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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03526861




Registration number
NCT03526861
Ethics application status
Date submitted
4/05/2018
Date registered
16/05/2018
Date last updated
3/07/2019

Titles & IDs
Public title
Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Scientific title
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre Trial to Evaluate the Efficacy, Safety, and Tolerability of Tralokinumab Monotherapy in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) Who Are Candidates for Systemic Therapy
Secondary ID [1] 0 0
2017-005143-33
Secondary ID [2] 0 0
LP0162-1334
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 - Tralokinumab
Treatment: Drugs - Placebos

Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceA - Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 1) maintenance SC injection regimen A.

Experimental: Tralokinumab(Dose1) initial-> Tralokinumab(Dose1) maintenanceB - Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 1) maintenance SC injection regimen B.

Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceA - Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 2) maintenance SC injection regimen A.

Experimental: Tralokinumab(Dose2) initial-> Tralokinumab(Dose2) maintenanceB - Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52 (maintenance period):
Tralokinumab (Dose 2) maintenance SC injection regimen B.

Experimental: Placebo initial-> Placebo maintenance - Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52 (maintenance period):
Placebo continuation SC injection regimen A.

Experimental: Tralokinumab (Dose1) initial-> Open-label tralokinumab - Week 0 to 16 (initial period):
Tralokinumab (Dose 1) loading SC injection on Day 0 followed by tralokinumab (Dose 1) injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Experimental: Tralokinumab (Dose2) initial-> Open-label tralokinumab - Week 0 to 16 (initial period):
Tralokinumab (Dose 2) loading SC injection on Day 0 followed by tralokinumab (Dose 2) injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids

Experimental: Placebo initial-> Open-label tralokinumab - Week 0 to 16 (initial period):
Placebo loading SC injection on Day 0 followed by placebo injection regimen A.
Week 16 to 52:
Tralokinumab (Dose 1) maintenance SC regimen A - open-label with allowed use of topical corticosteroids


Treatment: Drugs: Tralokinumab
Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.

Treatment: Drugs: Placebos
Placebo contains the same excipients in the same concentration only lacking tralokinumab.

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

Outcomes
Primary outcome [1] 0 0
Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) at Week 16. - The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Timepoint [1] 0 0
16 weeks
Primary outcome [2] 0 0
At least 75% reduction in Eczema Area and Severity Index (EASI75) at Week 16. - The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe and/or more extensive condition.
Timepoint [2] 0 0
16 weeks
Secondary outcome [1] 0 0
Change in Scoring Atopic Dermatitis (SCORAD) from baseline to Week 16. - The SCORAD is a validated tool to evaluate the extent and severity of AD lesions, along with subjective symptoms. The maximum total score is 103, with higher values indicating more severe disease.
Timepoint [1] 0 0
16 weeks
Secondary outcome [2] 0 0
Reduction of Adolescent Pruritus numeric rating scale (NRS) (weekly average) of at least 4 from baseline to Week 16. - The Adolescent Pruritus NRS is used by subjects to assess their worst itch over the past 24 hours using an 11-point NRS with 0 indicating 'no itch' and 10 indicating 'worst itch possible'.
Timepoint [2] 0 0
16 weeks
Secondary outcome [3] 0 0
Change in Children's Dermatology Life Quality Index (CDLQI) score from baseline to Week 16. - The CDLQI is a validated questionnaire with content specific to those with dermatology conditions. It consists of 10 items addressing the subject's perception of the impact of their skin disease on various aspects of their quality of life over the last week such as dermatology-related symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and the treatment. Each item is scored on a 4-point Likert scale (0 = 'not at all'; 1 = 'only a little'; 2 = 'quite a lot'; 3 = 'very much'). Item 7 (on school time) has one additional response category 'prevented school', which is also scored '3'. The total score of the CDLQI is the sum of the 10 items (0 to 30); a high score is indicative of a poor quality of life.
Timepoint [3] 0 0
16 weeks
Secondary outcome [4] 0 0
Number of adverse events.
Timepoint [4] 0 0
66 weeks
Secondary outcome [5] 0 0
Occurrence of anti-drug antibodies (yes/no).
Timepoint [5] 0 0
66 weeks

Eligibility
Key inclusion criteria
- Age 12 to 17.

- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.

- History of AD for =1 year.

- History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or
lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for
whom these topical AD treatments are medically inadvisable.

- AD involvement of =10% body surface area at screening and baseline.

- Stable dose of emollient twice daily (or more, as needed) for at least 14 days before
randomisation.
Minimum age
12 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active dermatologic conditions that may confound the diagnosis of AD.

- Use of tanning beds or phototherapy within 6 weeks prior to randomisation.

- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic
corticosteroid within 4 weeks prior to randomisation.

- Treatment with TCS, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2
weeks prior to randomisation.

- Receipt of any marketed biological therapy (i.e. immunoglobulin, anti immunoglobulin
E) including dupilumab or investigational biologic agents.

- Active skin infection within 1 week prior to randomisation.

- Clinically significant infection within 4 weeks prior to randomisation.

- A helminth parasitic infection within 6 months prior to the date informed consent is
obtained.

- Tuberculosis requiring treatment within the 12 months prior to screening.

- Known primary immunodeficiency disorder.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Leo Pharma Investigationel Site - Darlinghurst
Recruitment hospital [2] 0 0
Leo Pharma Investigationel Site - Kogarah
Recruitment hospital [3] 0 0
Leo Pharma Investigationel Site - Melbourne
Recruitment hospital [4] 0 0
Leo Pharma Investigationel Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
3002 - Melbourne
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kentucky
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Louisiana
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Minnesota
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Belgium
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Brugge
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Brussels
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Gent
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Belgium
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Liège
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Lille
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Dresden
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Germany
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Jena
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Osnabrück
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Fukuoka
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Kagoshima city
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Kyoto
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Nagoya-shi
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Obihiro
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Osaka-fu
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Osaka
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Shimotsuke
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Tsu
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Yamanashi
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Netherlands
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Bergen Op Zoom
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Breda
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Groningen
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Netherlands
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Rotterdam
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Poland
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Kraków
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Rzeszów
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Swidnik
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Wroclaw
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Lódz
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LEO Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Primary objective:

To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with
placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and
health-related quality of life compared with placebo.

To investigate the safety, immunogenicity, and tolerability of SC administration of
tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18
years) with moderate-to-severe AD.
Trial website
https://clinicaltrials.gov/show/NCT03526861
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical expert
Address 0 0
LEO Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
LEO Pharma A/S
Address 0 0
Country 0 0
Phone 0 0
(+1) 877-557-1168
Fax 0 0
Email 0 0
disclosure@leo-pharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03526861