Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
The ANZCTR website will be unavailable from 1pm until 2:30pm (AEDT) on Thursday the 16th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
A database of clinical trials and their results from Australia, New Zealand, and other countries.
account_circle
Log in
to register or update your trial
search
Search for trials
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06407934
Registration number
NCT06407934
Ethics application status
Date submitted
6/05/2024
Date registered
9/05/2024
Date last updated
27/08/2025
Titles & IDs
Public title
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Query!
Scientific title
A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Query!
Secondary ID [1]
0
0
U1111-1290-9215
Query!
Secondary ID [2]
0
0
EFC17600
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ESTUARY
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo
Experimental: Amlitelimab dose 1 - Subcutaneous injection as per protocol
Experimental: Amlitelimab dose 2 - Subcutaneous injection as per protocol
Placebo comparator: Placebo - Subcutaneous injection as per protocol
Treatment: Drugs: Amlitelimab
Pharmaceutical form: Injection solution
Route of administration: Subcutaneous (SC) injection
Treatment: Drugs: Placebo
Pharmaceutical form: Injection solution
Route of administration: SC injection
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of participants who maintain treatment response at Week 48 of ESTUARY.
Query!
Assessment method [1]
0
0
Maintenance of clinical response is defined as having validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 (clear) or 1 (almost clear) and/or 75% reduction in Eczema Area and Severity Index (EASI) compared to parent study baseline EASI (EASI-75). The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Query!
Timepoint [1]
0
0
Week 48
Query!
Secondary outcome [1]
0
0
Responders from parent studies: Proportion of participants who continue to be EASI-75 among the participants who met EASI-75 at baseline of ESTUARY
Query!
Assessment method [1]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
Query!
Timepoint [1]
0
0
Up to Week 48
Query!
Secondary outcome [2]
0
0
Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) among participants who met vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
Query!
Assessment method [2]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [2]
0
0
Up to Week 48
Query!
Secondary outcome [3]
0
0
Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among those who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY
Query!
Assessment method [3]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear), 1 (almost clear) to 4 (severe). Barely perceptible erythema with no induration/papulation, no lichenification, no oozing or crusting.
Query!
Timepoint [3]
0
0
Up to Week 48
Query!
Secondary outcome [4]
0
0
Responders from parent studies: Proportion of participants who maintained weekly average of daily PP-NRS reduction of =4 among the participants with weekly average of daily PP-NRS reduction of = 4 at baseline of ESTUARY
Query!
Assessment method [4]
0
0
The Peak Pruritus-Numerical Rating Scale (PP-NRS) is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [4]
0
0
Up to Week 48
Query!
Secondary outcome [5]
0
0
Proportion of participants who maintain treatment response in ESTUARY
Query!
Assessment method [5]
0
0
Maintenance of treatment response is defined as having vIGA-AD 0 (clear) or 1 (almost clear) and/or 75% reduction in EASI compared to parent study baseline EASI. The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Query!
Timepoint [5]
0
0
Up to Week 44
Query!
Secondary outcome [6]
0
0
Responders from parent studies: Percent change in EASI from parent study baseline
Query!
Assessment method [6]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Query!
Timepoint [6]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [7]
0
0
Responders from parent studies: Proportion of participants with EASI-75
Query!
Assessment method [7]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
Query!
Timepoint [7]
0
0
Up to Week 48
Query!
Secondary outcome [8]
0
0
Responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY
Query!
Assessment method [8]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Query!
Timepoint [8]
0
0
Up to Week 48
Query!
Secondary outcome [9]
0
0
Responders from parent studies: Proportion of participants with EASI-50
Query!
Assessment method [9]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Query!
Timepoint [9]
0
0
Up to Week 48
Query!
Secondary outcome [10]
0
0
Responders from parent studies: Proportion of participants who continue to be EASI-90 among the participants who met EASI-90 at baseline of ESTUARY
Query!
Assessment method [10]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
Query!
Timepoint [10]
0
0
Up to Week 48
Query!
Secondary outcome [11]
0
0
Responders from parent studies: Proportion of participants with EASI-90
Query!
Assessment method [11]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
Query!
Timepoint [11]
0
0
Up to Week 48
Query!
Secondary outcome [12]
0
0
Responders from parent studies: Proportion of participants who continue to be EASI-100 among the participants who met EASI-100 at baseline of ESTUARY
Query!
Assessment method [12]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
Query!
Timepoint [12]
0
0
Up to Week 48
Query!
Secondary outcome [13]
0
0
Responders from parent studies: Proportion of participants with EASI-100
Query!
Assessment method [13]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
Query!
Timepoint [13]
0
0
Up to Week 48
Query!
Secondary outcome [14]
0
0
Responders from parent studies: Time to the first event of loss of EASI-75 response among the participants who were EASI-75 responders at baseline of ESTUARY
Query!
Assessment method [14]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
Query!
Timepoint [14]
0
0
Up to Week 48
Query!
Secondary outcome [15]
0
0
Responders from parent studies: Time to the first event of loss of EASI-50 response among the participants who were EASI-50 responders at baseline of ESTUARY
Query!
Assessment method [15]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Query!
Timepoint [15]
0
0
Up to Week 48
Query!
Secondary outcome [16]
0
0
Responders from parent studies: Time to the first event of loss of EASI-90 response among the participants who were EASI-90 responders at baseline of ESTUARY
Query!
Assessment method [16]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
Query!
Timepoint [16]
0
0
Up to Week 48
Query!
Secondary outcome [17]
0
0
Responders from parent studies: Time to the first event of loss of EASI-100 among participants who were EASI-100 at baseline of ESTUARY
Query!
Assessment method [17]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
Query!
Timepoint [17]
0
0
Up to Week 48
Query!
Secondary outcome [18]
0
0
Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)
Query!
Assessment method [18]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [18]
0
0
Up to Week 48
Query!
Secondary outcome [19]
0
0
Responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
Query!
Assessment method [19]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [19]
0
0
Up to Week 48
Query!
Secondary outcome [20]
0
0
Responders from parent studies: Time to first event of vIGA-AD =3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
Query!
Assessment method [20]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [20]
0
0
Up to Week 48
Query!
Secondary outcome [21]
0
0
Responders from parent studies: Time to first event of vIGA-AD =3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY
Query!
Assessment method [21]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [21]
0
0
Up to Week 48
Query!
Secondary outcome [22]
0
0
Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY
Query!
Assessment method [22]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [22]
0
0
Up to Week 48
Query!
Secondary outcome [23]
0
0
Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 3 (moderate) at baseline of parent study
Query!
Assessment method [23]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [23]
0
0
Up to Week 48
Query!
Secondary outcome [24]
0
0
Responders from parent studies: Proportion of participants who have an increase of =2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 4 (severe) at baseline of parent study
Query!
Assessment method [24]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [24]
0
0
Up to Week 48
Query!
Secondary outcome [25]
0
0
Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75 at baseline of ESTUARY
Query!
Assessment method [25]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
Query!
Timepoint [25]
0
0
Up to Week 48
Query!
Secondary outcome [26]
0
0
Responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily PP-NRS from parent study baseline
Query!
Assessment method [26]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [26]
0
0
Up to Week 48
Query!
Secondary outcome [27]
0
0
Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline
Query!
Assessment method [27]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [27]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [28]
0
0
Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
Query!
Assessment method [28]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [28]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [29]
0
0
Responders from parent studies: Proportion of participants who maintained PP-NRS 0 or 1 among the participants who were PP-NRS 0 or 1 at baseline of ESTUARY
Query!
Assessment method [29]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [29]
0
0
Up to Week 48
Query!
Secondary outcome [30]
0
0
Responders from parent studies: Proportion of participants who maintained vIGA-AD 0 or 1 and/or EASI-75 and weekly average of daily (WAD) PP-NRS reduction >4 among those who were vIGA-AD 0 or 1 and/or EASI-75 and WAD PP-NRS reduction >4 at BL of ESTUARY
Query!
Assessment method [30]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear), 1 (almost clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The Peak Pruritus-Numerical Rating Scale (PP-NRS) is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. BL=baseline.
Query!
Timepoint [30]
0
0
Up to Week 48
Query!
Secondary outcome [31]
0
0
Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
Query!
Assessment method [31]
0
0
The Sleep Disturbance-Numerical Rating Scale (SD-NRS) is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Query!
Timepoint [31]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [32]
0
0
Responders from parent studies: Proportion of participants who maintained weekly average of daily SD-NRS reduction of = 3 among the participants with weekly average of daily SD-NRS reduction of =3 at baseline of ESTUARY
Query!
Assessment method [32]
0
0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Query!
Timepoint [32]
0
0
Up to Week 48
Query!
Secondary outcome [33]
0
0
Responders from parent studies: Proportion of participants with =3 points reduction in weekly average of daily SD-NRS from parent study baseline
Query!
Assessment method [33]
0
0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Query!
Timepoint [33]
0
0
Up to Week 48
Query!
Secondary outcome [34]
0
0
Responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily SP-NRS from parent study baseline
Query!
Assessment method [34]
0
0
The Skin Pain-Numerical Rating Scale (SP-NRS) is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Query!
Timepoint [34]
0
0
Up to Week 48
Query!
Secondary outcome [35]
0
0
Responders from parent studies: Proportion of participants who maintained weekly average of daily SP-NRS reduction of = 4 among the participants with weekly average of daily SP-NRS reduction of =4 at ESTUARY baseline
Query!
Assessment method [35]
0
0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Query!
Timepoint [35]
0
0
Up to Week 48
Query!
Secondary outcome [36]
0
0
Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
Query!
Assessment method [36]
0
0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Query!
Timepoint [36]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [37]
0
0
Responders from parent studies: Proportion of participants who maintained SCORAD = 8.7 among participants with reduction in SCORAD = 8.7 at baseline of ESTUARY
Query!
Assessment method [37]
0
0
The Scoring Atopic Dermatitis (SCORAD) index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Query!
Timepoint [37]
0
0
Up to Week 48
Query!
Secondary outcome [38]
0
0
Responders from parent studies: Percent change in SCORAD index from parent study baseline
Query!
Assessment method [38]
0
0
The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Query!
Timepoint [38]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [39]
0
0
Responders from parent studies: Absolute change in SCORAD index from parent study baseline
Query!
Assessment method [39]
0
0
The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Query!
Timepoint [39]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [40]
0
0
Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline
Query!
Assessment method [40]
0
0
Query!
Timepoint [40]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [41]
0
0
Responders from parent studies: Proportion of participants who maintained POEM =4 among the participants with reduction in POEM =4 at baseline of ESTUARY
Query!
Assessment method [41]
0
0
The Patient Oriented Eczema Measure (POEM) is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
Query!
Timepoint [41]
0
0
Up to Week 48
Query!
Secondary outcome [42]
0
0
Responders from parent studies: Change in POEM from parent study baseline
Query!
Assessment method [42]
0
0
The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
Query!
Timepoint [42]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [43]
0
0
Responders from parent studies: Proportion of participants with a reduction in Children's Dermatology Life Quality Index (CDLQI) =6 among participants aged =12 to <16 years old and with CDLQI baseline =6
Query!
Assessment method [43]
0
0
The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [43]
0
0
Up to Week 48
Query!
Secondary outcome [44]
0
0
Responders from parent studies: Change in CDLQI in participants with age =12 to <16 years old
Query!
Assessment method [44]
0
0
The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [44]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [45]
0
0
Responders from parent studies: Change in Dermatology Life Quality Index (DLQI) in participants with age =16 years among the participants with DLQI =4 at parent study baseline
Query!
Assessment method [45]
0
0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [45]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [46]
0
0
Responders from parent studies: Proportion of participants with = 4 points reduction in DLQI from parent study baseline among the participants with DLQI =4 at parent study baseline
Query!
Assessment method [46]
0
0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [46]
0
0
Up to Week 48
Query!
Secondary outcome [47]
0
0
Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D =8 at parent study baseline
Query!
Assessment method [47]
0
0
The Hospital Anxiety Depression Scale-Depression (HADS) ranges 0-21 with higher score indicating a poorer state.
Query!
Timepoint [47]
0
0
Up to Week 48
Query!
Secondary outcome [48]
0
0
Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A =8 at parent study baseline
Query!
Assessment method [48]
0
0
The Hospital Anxiety Depression Scale-Anxiety (HADS-A) ranges 0-21 with higher score indicating a poorer state.
Query!
Timepoint [48]
0
0
Up to Week 48
Query!
Secondary outcome [49]
0
0
Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY
Query!
Assessment method [49]
0
0
Query!
Timepoint [49]
0
0
Up to Week 48
Query!
Secondary outcome [50]
0
0
Responders from parent studies: Time to first rescue medication initiation
Query!
Assessment method [50]
0
0
Query!
Timepoint [50]
0
0
Up to Week 48
Query!
Secondary outcome [51]
0
0
Non-responders from parent studies: Percent change in EASI from parent study baseline
Query!
Assessment method [51]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Query!
Timepoint [51]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [52]
0
0
Non-responders from parent studies: Proportion of participants with EASI-75
Query!
Assessment method [52]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
Query!
Timepoint [52]
0
0
Up to Week 48
Query!
Secondary outcome [53]
0
0
Non-responders from parent studies: Proportion of participants who continue to be EASI-50 among the participants who met EASI-50 at baseline of ESTUARY
Query!
Assessment method [53]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Query!
Timepoint [53]
0
0
Up to Week 48
Query!
Secondary outcome [54]
0
0
Non-responders from parent studies: Proportion of participants with EASI-50
Query!
Assessment method [54]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Query!
Timepoint [54]
0
0
Up to Week 48
Query!
Secondary outcome [55]
0
0
Non-responders from parent studies: Proportion of participants with EASI-90
Query!
Assessment method [55]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
Query!
Timepoint [55]
0
0
Up to Week 48
Query!
Secondary outcome [56]
0
0
Non-responders from parent studies: Proportion of participants with EASI-100
Query!
Assessment method [56]
0
0
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
Query!
Timepoint [56]
0
0
Up to Week 48
Query!
Secondary outcome [57]
0
0
Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)
Query!
Assessment method [57]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [57]
0
0
Up to Week 48
Query!
Secondary outcome [58]
0
0
Non-responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
Query!
Assessment method [58]
0
0
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Query!
Timepoint [58]
0
0
Up to Week 48
Query!
Secondary outcome [59]
0
0
Non-responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily PP-NRS from parent study baseline
Query!
Assessment method [59]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [59]
0
0
Up to Week 48
Query!
Secondary outcome [60]
0
0
Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline
Query!
Assessment method [60]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [60]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [61]
0
0
Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline
Query!
Assessment method [61]
0
0
The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Query!
Timepoint [61]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [62]
0
0
Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline
Query!
Assessment method [62]
0
0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Query!
Timepoint [62]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [63]
0
0
Non-responders from parent studies: Proportion of participants with =3 points reduction in weekly average of daily SD-NRS from parent study baseline
Query!
Assessment method [63]
0
0
The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Query!
Timepoint [63]
0
0
Up to Week 48
Query!
Secondary outcome [64]
0
0
Non-responders from parent studies: Proportion of participants with = 4 points reduction in weekly average of daily SP-NRS from parent study baseline [
Query!
Assessment method [64]
0
0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Query!
Timepoint [64]
0
0
Up to Week 48
Query!
Secondary outcome [65]
0
0
Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline
Query!
Assessment method [65]
0
0
The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Query!
Timepoint [65]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [66]
0
0
Non-responders from parent studies: Proportion of participants with a reduction in CDLQI =6 among participants aged =12 to <16 years old and with CDLQI =6 at parent study baseline
Query!
Assessment method [66]
0
0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [66]
0
0
Up to Week 48
Query!
Secondary outcome [67]
0
0
Non-responders from parent studies: Change in CDLQI in participants with age =12 to <16 years old
Query!
Assessment method [67]
0
0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [67]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [68]
0
0
Non-responders from parent studies: Change in DLQI in participants with age =16 years among the participants with DLQI =4 at parent study baseline
Query!
Assessment method [68]
0
0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [68]
0
0
Parent study baseline to Week 48
Query!
Secondary outcome [69]
0
0
Non-responders from parent studies: Proportion of participants with = 4 points reduction in DLQI from parent study baseline among the participants with DLQI =4 at parent study baseline
Query!
Assessment method [69]
0
0
The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Query!
Timepoint [69]
0
0
Up to Week 48
Query!
Secondary outcome [70]
0
0
Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D =8 at parent study baseline
Query!
Assessment method [70]
0
0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Query!
Timepoint [70]
0
0
Up to Week 48
Query!
Secondary outcome [71]
0
0
Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A =8 at parent study baseline
Query!
Assessment method [71]
0
0
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Query!
Timepoint [71]
0
0
Up to Week 48
Query!
Secondary outcome [72]
0
0
All participants: Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
Query!
Assessment method [72]
0
0
Query!
Timepoint [72]
0
0
Up to week 68
Query!
Secondary outcome [73]
0
0
All participants: Serum amlitelimab concentrations measured at prespecified timepoints
Query!
Assessment method [73]
0
0
Query!
Timepoint [73]
0
0
Up to Week 68
Query!
Secondary outcome [74]
0
0
All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab
Query!
Assessment method [74]
0
0
Query!
Timepoint [74]
0
0
Up to Week 68
Query!
Eligibility
Key inclusion criteria
* Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
* Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD.
* Able and willing to comply with requested study visit and procedures.
* Body weight must be = 25 kg.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Participants are excluded from the study if any of the following criteria apply:
* Developed a medical condition that would preclude participation as described in Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols.
* Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE).
* Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant.
* Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study.
* Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.).
* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
8/05/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
5/04/2027
Query!
Actual
Query!
Sample size
Target
961
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Investigational Site Number : 7240015 - Coffs Harbour
Query!
Recruitment hospital [2]
0
0
Investigational Site Number : 0360010 - Westmead
Query!
Recruitment hospital [3]
0
0
Investigational Site Number : 0320010 - Birtinya
Query!
Recruitment hospital [4]
0
0
Investigational Site Number : 0320008 - Maroochydore
Query!
Recruitment hospital [5]
0
0
Investigational Site Number : 0360007 - Woolloongabba
Query!
Recruitment hospital [6]
0
0
Investigational Site Number : 0360008 - Melbourne
Query!
Recruitment hospital [7]
0
0
Investigational Site Number : 0360006 - Melbourne
Query!
Recruitment hospital [8]
0
0
Investigational Site Number : 0361006 - Saint Petersburg
Query!
Recruitment hospital [9]
0
0
Fremantle Hospital- Site Number : 8401050 - Perth
Query!
Recruitment postcode(s) [1]
0
0
2450 - Coffs Harbour
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [4]
0
0
4558 - Maroochydore
Query!
Recruitment postcode(s) [5]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [6]
0
0
3002 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [8]
0
0
197376 - Saint Petersburg
Query!
Recruitment postcode(s) [9]
0
0
6160 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Mississippi
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nevada
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Mexico
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Ohio
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Dakota
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Utah
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Santa Fe Province
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Tucumán Province
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Corrientes
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Mendoza
Query!
Country [35]
0
0
Austria
Query!
State/province [35]
0
0
Cornwall
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Espírito Santo
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Estado de Bahia
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Paraná
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Rio Grande do Sul
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
São Paulo
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Rio de Janeiro
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Pleven
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Sofia
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Alberta
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
British Columbia
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Manitoba
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Ontario
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Quebec
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Saskatchewan
Query!
Country [50]
0
0
Chile
Query!
State/province [50]
0
0
Los Lagos Region
Query!
Country [51]
0
0
Chile
Query!
State/province [51]
0
0
Reg Metropolitana de Santiago
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Región de Valparaíso
Query!
Country [53]
0
0
Chile
Query!
State/province [53]
0
0
Región del Biobío
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Gyeonggi-do
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Beijing
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Changsha
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Chengdu
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Chongqing
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Guangzhou
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Hangzhou
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Jinan
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Nanchang
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Ningbo
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Shanghai
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Shenyang
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Shenzhen
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Wenzhou
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Wuhan
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Wuxi
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Yinchuan
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Zhenjiang
Query!
Country [72]
0
0
Colombia
Query!
State/province [72]
0
0
Ontario
Query!
Country [73]
0
0
Colombia
Query!
State/province [73]
0
0
Texas
Query!
Country [74]
0
0
Croatia
Query!
State/province [74]
0
0
Zagreb
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Kutná Hora
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Nový Jicín
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Olomouc
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Prague
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Tainan CITY
Query!
Country [80]
0
0
Denmark
Query!
State/province [80]
0
0
Aalborg
Query!
Country [81]
0
0
Denmark
Query!
State/province [81]
0
0
Aarhus
Query!
Country [82]
0
0
Denmark
Query!
State/province [82]
0
0
Herlev
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Buenos Aires
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
California
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Valparaíso
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Antony
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Nice
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Paris
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Pierre-Bénite
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Romans-sur-Isère
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Rouen
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Toulouse
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Tours
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Louisiana
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Maranhão
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Ontario
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Texas
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Augsburg
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Hamburg
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Kiel
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Mainz
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Münster
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Witten
Query!
Country [104]
0
0
Greece
Query!
State/province [104]
0
0
Santa Fe
Query!
Country [105]
0
0
Greece
Query!
State/province [105]
0
0
Athens
Query!
Country [106]
0
0
India
Query!
State/province [106]
0
0
Reg Metropolitana de Santiago
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Ahmedabad
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
Belagavi
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Chandigarh
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Haryana
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Kolkata
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Nagpur
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Pune
Query!
Country [114]
0
0
Ireland
Query!
State/province [114]
0
0
Dublin
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Afula
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Beersheba
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Haifa
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Jerusalem
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
Petah Tikva
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Safed
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Milano
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Roma
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Bologna
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Catania
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Como
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
L’Aquila
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Pisa
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Busan-gwangyeoksi
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Hokkaido
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Hyogo
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Kanagawa
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Miyagi
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Osaka
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Tochigi
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Tokyo
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Kagoshima
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Kyoto
Query!
Country [138]
0
0
Malaysia
Query!
State/province [138]
0
0
Buenos Aires
Query!
Country [139]
0
0
Mexico
Query!
State/province [139]
0
0
Nuevo León
Query!
Country [140]
0
0
Mexico
Query!
State/province [140]
0
0
Aguascalientes
Query!
Country [141]
0
0
Mexico
Query!
State/province [141]
0
0
Veracruz
Query!
Country [142]
0
0
Netherlands
Query!
State/province [142]
0
0
Rotterdam
Query!
Country [143]
0
0
Peru
Query!
State/province [143]
0
0
Ontario
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Lesser Poland Voivodeship
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Lower Silesian Voivodeship
Query!
Country [146]
0
0
Poland
Query!
State/province [146]
0
0
Lublin Voivodeship
Query!
Country [147]
0
0
Poland
Query!
State/province [147]
0
0
Lódzkie
Query!
Country [148]
0
0
Poland
Query!
State/province [148]
0
0
Masovian Voivodeship
Query!
Country [149]
0
0
Poland
Query!
State/province [149]
0
0
Pomeranian Voivodeship
Query!
Country [150]
0
0
Portugal
Query!
State/province [150]
0
0
Lisbon
Query!
Country [151]
0
0
Portugal
Query!
State/province [151]
0
0
Porto
Query!
Country [152]
0
0
Singapore
Query!
State/province [152]
0
0
Saskatchewan
Query!
Country [153]
0
0
Slovakia
Query!
State/province [153]
0
0
Buenos Aires
Query!
Country [154]
0
0
Slovakia
Query!
State/province [154]
0
0
South Carolina
Query!
Country [155]
0
0
Slovakia
Query!
State/province [155]
0
0
Valencia
Query!
Country [156]
0
0
South Africa
Query!
State/province [156]
0
0
Benoni
Query!
Country [157]
0
0
South Africa
Query!
State/province [157]
0
0
Cape Town
Query!
Country [158]
0
0
South Africa
Query!
State/province [158]
0
0
Durban
Query!
Country [159]
0
0
South Africa
Query!
State/province [159]
0
0
Johannesburg
Query!
Country [160]
0
0
South Africa
Query!
State/province [160]
0
0
Pretoria
Query!
Country [161]
0
0
South Korea
Query!
State/province [161]
0
0
Daegu
Query!
Country [162]
0
0
South Korea
Query!
State/province [162]
0
0
Gwangju
Query!
Country [163]
0
0
South Korea
Query!
State/province [163]
0
0
Gyeonggi-do
Query!
Country [164]
0
0
South Korea
Query!
State/province [164]
0
0
Gyeongsangnam-do
Query!
Country [165]
0
0
South Korea
Query!
State/province [165]
0
0
Incheon-gwangyeoksi
Query!
Country [166]
0
0
South Korea
Query!
State/province [166]
0
0
Seoul-teukbyeolsi
Query!
Country [167]
0
0
Spain
Query!
State/province [167]
0
0
Barcelona [Barcelona]
Query!
Country [168]
0
0
Spain
Query!
State/province [168]
0
0
Basque Country
Query!
Country [169]
0
0
Spain
Query!
State/province [169]
0
0
Las Palmas
Query!
Country [170]
0
0
Spain
Query!
State/province [170]
0
0
Pontevedra [Pontevedra]
Query!
Country [171]
0
0
Spain
Query!
State/province [171]
0
0
Sevilla
Query!
Country [172]
0
0
Spain
Query!
State/province [172]
0
0
Alicante
Query!
Country [173]
0
0
Spain
Query!
State/province [173]
0
0
Granada
Query!
Country [174]
0
0
Spain
Query!
State/province [174]
0
0
Madrid
Query!
Country [175]
0
0
Spain
Query!
State/province [175]
0
0
Valencia
Query!
Country [176]
0
0
Sweden
Query!
State/province [176]
0
0
Mazowieckie
Query!
Country [177]
0
0
Sweden
Query!
State/province [177]
0
0
Slaskie
Query!
Country [178]
0
0
Sweden
Query!
State/province [178]
0
0
Älvsjö
Query!
Country [179]
0
0
Sweden
Query!
State/province [179]
0
0
Örebro
Query!
Country [180]
0
0
Taiwan
Query!
State/province [180]
0
0
Kaohsiung City
Query!
Country [181]
0
0
Taiwan
Query!
State/province [181]
0
0
Taichung
Query!
Country [182]
0
0
Taiwan
Query!
State/province [182]
0
0
Taipei
Query!
Country [183]
0
0
Tunisia
Query!
State/province [183]
0
0
Michigan
Query!
Country [184]
0
0
Turkey (Türkiye)
Query!
State/province [184]
0
0
Antalya
Query!
Country [185]
0
0
Turkey (Türkiye)
Query!
State/province [185]
0
0
Gaziantep
Query!
Country [186]
0
0
Turkey (Türkiye)
Query!
State/province [186]
0
0
Istanbul
Query!
Country [187]
0
0
Turkey (Türkiye)
Query!
State/province [187]
0
0
Kayseri
Query!
Country [188]
0
0
Turkey (Türkiye)
Query!
State/province [188]
0
0
Samsun
Query!
Country [189]
0
0
United Kingdom
Query!
State/province [189]
0
0
England
Query!
Country [190]
0
0
United Kingdom
Query!
State/province [190]
0
0
Hampshire
Query!
Country [191]
0
0
United Kingdom
Query!
State/province [191]
0
0
Leicestershire
Query!
Country [192]
0
0
United Kingdom
Query!
State/province [192]
0
0
London, City of
Query!
Country [193]
0
0
United Kingdom
Query!
State/province [193]
0
0
Doncaster
Query!
Country [194]
0
0
United Kingdom
Query!
State/province [194]
0
0
Glasgow
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 \[COAST-1\], EFC17560 \[COAST 2\], EFC17561 \[SHORE\]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).
Query!
Trial website
https://clinicaltrials.gov/study/NCT06407934
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Trial Transparency email recommended (Toll free for US & Canada)
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
800-633-1610
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06407934
Download to PDF