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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04212169




Registration number
NCT04212169
Ethics application status
Date submitted
4/11/2019
Date registered
26/12/2019
Date last updated
28/09/2023

Titles & IDs
Public title
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Scientific title
A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI3506 in Adult Subjects With Moderate-to-severe Atopic Dermatitis
Secondary ID [1] 0 0
2019-003304-12
Secondary ID [2] 0 0
D9182C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEDI3506
Treatment: Drugs - Placebo

Experimental: MEDI3506 at dose level 1 - Participant will receive multiple doses of MEDI3506 at dose level 1.

Experimental: MEDI3506 at dose level 2 - Participant will receive multiple doses of MEDI3506 at dose level 2.

Experimental: MEDI3506 at dose level 3 - Participant will receive multiple doses of MEDI3506 at dose level 3.

Placebo comparator: Placebo - Participant will receive multiple doses of Placebo


Treatment: Drugs: MEDI3506
multiple doses

Treatment: Drugs: Placebo
multiple doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline to Week 16 in EASI Score
Assessment method [1] 0 0
The EASI evaluates 4 anatomic regions for severity and extent of key disease signs and focuses on the acute and chronic signs of inflammation (ie, erythema, edema, papulation, excoriation, and lichenification). The maximum score is 72, with higher values indicating more severe disease. Analysis was performed using mixed effect model for repeated measures and MCP-mod dose response model.
Timepoint [1] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Subjects Achieving a 90% Reduction From Baseline in EASI Score at Week 16
Assessment method [1] 0 0
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 90% reduction from baseline in EASI score.
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Subjects Achieving a 75% Reduction From Baseline in EASI Score at Week 16
Assessment method [2] 0 0
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 75% reduction from baseline in EASI score.
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Subjects Achieving a 50% Reduction From Baseline in EASI Score at Week 16
Assessment method [3] 0 0
To further assess the effects of MEDI3506 compared with placebo on AD disease severity, in adult subjects with moderate-to-severe AD. Responders are subjects who achieved at least 50% reduction from baseline in EASI score.
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Subjects Achieving an IGA of 0 (Clear) or 1 (Almost Clear) With at Least a 2 Grade Reduction From Baseline Score at Week 16
Assessment method [4] 0 0
The IGA allows investigators to assess overall AD disease severity at 1 given time point and consists of a 5-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, and 4 = severe disease).
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Subjects Achieving a Reduction of = 3 From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Assessment method [5] 0 0
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Pruritus NRS
Assessment method [6] 0 0
Peak pruritus (ie, worst itch experienced in the previous 24 hours) assessed using an Numerical Rating Scale (NRS; 0 to 10) with 0 = no itch and 10 = worst imaginable itch. The daily assessments were summarised as a weekly mean.
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Change From Baseline to Week 16 in Weekly Mean of Daily Peak Skin Pain NRS
Assessment method [7] 0 0
Skin pain (ie, worst skin pain experienced in the previous 24 hours) assessed using an NRS (0 to 10) with 0 = no pain and 10 = worst imaginable pain. The daily assessments were summarised as a weekly mean.
Timepoint [7] 0 0
Week 16
Secondary outcome [8] 0 0
SCORAD: Percent Change From Baseline to Week 16
Assessment method [8] 0 0
SCORAD is a clinical tool for assessing the severity of AD that evaluates the extent and intensity of AD lesions, in addition to subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Change From Baseline to Week 16 in Percentage Body Surface Area (BSA) Affected by AD
Assessment method [9] 0 0
Change in percentage of body surface area (BSA) affected by AD from baseline at week 16.
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
Change From Baseline to Week 16 in DLQI
Assessment method [10] 0 0
The Dermatology Life Quality Index (DLQI) is a 10-item, patient- completed, health-related quality of life assessment of dermatology conditions with a recall period of 1 week. Each item is scored on a 4-point Likert scale with 0 = not at all /not relevant, 1 = a little, 2 = a lot, and 3 = very much. The score from each item is summed, and the maximum total score is 30 while the minimum score is 0. Higher score means highest (adverse) effect on participant's life.
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Patient Description of Atopic Dermatitis or Eczema From Patient Global Impression of Severity at Week 16
Assessment method [11] 0 0
The Patient Global Impression of Severity (PGI-S) is a tool that allows patients to rate the severity of a condition over the past 7 days with response options of "No symptoms", "Very mild", "Mild", "Moderate", "Severe" and "Very severe".
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Change From Baseline to Week 16 in POEM
Assessment method [12] 0 0
The Patient-Oriented Eczema Measure (POEM) is a 7-item questionnaire for assessing disease symptoms including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping occurring in the past week. Each item is scored on a 5-point scale with 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = every day. The total POEM score is calculated by summing the score of each item resulting in a maximum of 28 and a minimum of 0, with higher values indicating severe disease
Timepoint [12] 0 0
Week 16
Secondary outcome [13] 0 0
Change From Baseline to Week 16 in 5-D Itch
Assessment method [13] 0 0
The 5-D Itch Scale is a questionnaire consisting of 5 items used specifically to measure the course of itch by asking for the degree, duration, disability and distribution of the pruritus within the last 2 weeks. The scores from each item are summed, with maximum score of 25 and minimum score of 5. Higher score represent worse outcome
Timepoint [13] 0 0
Week 16
Secondary outcome [14] 0 0
Occurrence of Adverse Events
Assessment method [14] 0 0
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [14] 0 0
up to 24 weeks
Secondary outcome [15] 0 0
Oral or Tympanic Temperature Taken During Vital Signs Assessment
Assessment method [15] 0 0
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [15] 0 0
Baseline, week 16 and week 24
Secondary outcome [16] 0 0
Systolic Blood Pressure Taken During Vital Signs Assessment
Assessment method [16] 0 0
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [16] 0 0
Baseline, week 16 and week 24
Secondary outcome [17] 0 0
Heart Rate Taken During Vital Signs Assessment
Assessment method [17] 0 0
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [17] 0 0
Baseline, week 16 and week 24
Secondary outcome [18] 0 0
Respiratory Rate Collected During Vital Signs Assessment
Assessment method [18] 0 0
Collectively with other vital signs assessment are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [18] 0 0
Baseline, week 16 and week 24
Secondary outcome [19] 0 0
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Haematology
Assessment method [19] 0 0
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [19] 0 0
up to 24 weeks
Secondary outcome [20] 0 0
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Serum Chemistry
Assessment method [20] 0 0
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [20] 0 0
up to 24 weeks
Secondary outcome [21] 0 0
Number of Participants With Abnormal Laboratory Assessments Relative to Normal Ranges for Urinalysis
Assessment method [21] 0 0
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [21] 0 0
up to 24 weeks
Secondary outcome [22] 0 0
Heart Rate (Beats/Min) Recorded on ECGs
Assessment method [22] 0 0
Collectively with other ECG parameters are used t assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [22] 0 0
Baseline, week 16 and week 24
Secondary outcome [23] 0 0
QT (Miliseconds) Recorded on ECGs
Assessment method [23] 0 0
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [23] 0 0
Baseline, week 16 and week 24
Secondary outcome [24] 0 0
Number of Participants With Investigator's Overall ECGs Evaluations, e.g. Normal/Abnormal and Their Clinical Significance
Assessment method [24] 0 0
Collectively with other ECG parameters are used to assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [24] 0 0
Week 16 and week 24
Secondary outcome [25] 0 0
Left Ventricular Ejection Fraction Measured by Echocardiogram
Assessment method [25] 0 0
To assess the safety and tolerability of MEDI3506 compared with placebo, in adult subjects with moderate-to-severe AD.
Timepoint [25] 0 0
Baseline and week 16
Secondary outcome [26] 0 0
Serum MEDI3506 Concentration Profiles
Assessment method [26] 0 0
To evaluate the PK of MEDI3506 in adult subjects with moderate-to-severe AD.
Timepoint [26] 0 0
Week 16 and week 24
Secondary outcome [27] 0 0
Occurence of Anti-drug Antibody During the Treatment and Follow-up Periods
Assessment method [27] 0 0
To evaluate the immunogenicity of MEDI3506 in adult subjects with moderate-to-severe AD.
Timepoint [27] 0 0
up to 24 weeks

Eligibility
Key inclusion criteria
* Age 18 to 65 years inclusive at the time of consent.
* Body mass index between 19.0 and 40.0 kg/m2 inclusive.
* Documented history of chronic AD, for at least 1 year prior to screening Visit 1.
* Meets at minimum 1 of the criteria, as follows:

* History of inadequate response to topical medications for AD
* Subject intolerance to treatment with topical medications for AD, or
* Topical medications are otherwise medically inadvisable
* AD that affects = 10% of the body surface area (BSA).
* An EASI score of = 12 at Visit 1 and = 16 at Visit 3 (Day 1).
* An IGA score of = 3.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
* Any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram [ECG]) or from safety laboratory analysis.
* Active dermatologic conditions that might confound the diagnosis of AD or would interfere with the assessment of the skin.
* Known active allergic or irritant contact dermatitis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/09/2022
Sample size
Target
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Carlton
Recruitment hospital [3] 0 0
Research Site - East Melbourne
Recruitment hospital [4] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3053 - Carlton
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Louisiana
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Rhode Island
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Tennessee
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Germany
State/province [11] 0 0
Berlin
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Hamburg
Country [14] 0 0
Germany
State/province [14] 0 0
Mahlow
Country [15] 0 0
Poland
State/province [15] 0 0
Bialystok
Country [16] 0 0
Poland
State/province [16] 0 0
Kielce
Country [17] 0 0
Poland
State/province [17] 0 0
Poznan
Country [18] 0 0
Poland
State/province [18] 0 0
Skierniewice
Country [19] 0 0
Poland
State/province [19] 0 0
Wroclaw
Country [20] 0 0
Poland
State/province [20] 0 0
Lódz
Country [21] 0 0
Spain
State/province [21] 0 0
Alcobendas
Country [22] 0 0
Spain
State/province [22] 0 0
Leganés
Country [23] 0 0
Spain
State/province [23] 0 0
Sevilla
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Corby
Country [25] 0 0
United Kingdom
State/province [25] 0 0
High Wycombe
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Kenilworth
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Northwood
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Romford
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Shipley
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sidcup
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Wokingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04212169