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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03526861
Ethics application status
Date submitted
4/05/2018
Date registered
16/05/2018

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
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 16
Timepoint [1] 0 0
At Week 16
Primary outcome [2] 0 0
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 16
Timepoint [2] 0 0
At Week 16
Secondary outcome [1] 0 0
Subjects With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 4 From Baseline to Week 16
Timepoint [1] 0 0
At Week 16
Secondary outcome [2] 0 0
Change in Scoring Atopic Dermatitis (SCORAD) From Baseline to Week 16
Timepoint [2] 0 0
From Week 0 to Week 16
Secondary outcome [3] 0 0
Change in Children's Dermatology Life Quality Index (CDLQI) Score From Baseline to Week 16
Timepoint [3] 0 0
From Week 0 to Week 16
Secondary outcome [4] 0 0
Number of Adverse Events
Timepoint [4] 0 0
From Week 0 to Week 16
Secondary outcome [5] 0 0
Presence of Anti-drug Antibodies
Timepoint [5] 0 0
From Week 0 to Week 16
Secondary outcome [6] 0 0
Subjects With at Least 50% Reduction in Eczema Area and Severity Index (EASI50) at Week 16.
Timepoint [6] 0 0
At Week 16
Secondary outcome [7] 0 0
Subjects With at Least 90% Reduction in Eczema Area and Severity Index (EASI90) at Week 16.
Timepoint [7] 0 0
At Week 16
Secondary outcome [8] 0 0
Change in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16
Timepoint [8] 0 0
From Week 0 to Week 16
Secondary outcome [9] 0 0
Subjects With at Least 75% Reduction in Scoring Atopic Dermatitis (SCORAD75) at Week 16
Timepoint [9] 0 0
At Week 16
Secondary outcome [10] 0 0
Subjects With at Least 50% Reduction in Scoring Atopic Dermatitis (SCORAD50) at Week 16
Timepoint [10] 0 0
At Week 16
Secondary outcome [11] 0 0
Change in Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) From Baseline to Week 16
Timepoint [11] 0 0
From Week 0 to Week 16
Secondary outcome [12] 0 0
Participants With Reduction of Adolescent Worst Pruritus Numeric Rating Scale (NRS) (Weekly Average) of at Least 3 From Baseline to Week 16
Timepoint [12] 0 0
At Week 16
Secondary outcome [13] 0 0
Change in Patient Oriented Eczema Measure (POEM) From Baseline to Week 16
Timepoint [13] 0 0
From Week 0 to Week 16
Secondary outcome [14] 0 0
Tralokinumab Serum Trough Concentration at Week 16
Timepoint [14] 0 0
At Week 16
Secondary outcome [15] 0 0
Subjects With Investigator's Global Assessment (IGA) Score of 0 (Clear) or 1 (Almost Clear) at Week 52 Among Subjects With IGA Score of 0 or 1 at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16
Timepoint [15] 0 0
At Week 52
Secondary outcome [16] 0 0
Subjects With at Least 75% Reduction in Eczema Area and Severity Index (EASI75) at Week 52 Among Subjects With at Least 75% Reduction in EASI at Week 16 After Initial Randomisation to Tralokinumab and Without Use of Rescue From Week 2 to Week 16
Timepoint [16] 0 0
At Week 52
Secondary outcome [17] 0 0
Tralokinumab Serum Trough Concentration at Week 66
Timepoint [17] 0 0
At Week 66

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/03/2021
Sample size
Target
Accrual to date
Final
301
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
Belgium
State/province [22] 0 0
Brussels
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Liège
Country [25] 0 0
Belgium
State/province [25] 0 0
Maldegem
Country [26] 0 0
Canada
State/province [26] 0 0
Alberta
Country [27] 0 0
Canada
State/province [27] 0 0
British Columbia
Country [28] 0 0
Canada
State/province [28] 0 0
Manitoba
Country [29] 0 0
Canada
State/province [29] 0 0
Ontario
Country [30] 0 0
Canada
State/province [30] 0 0
Quebec
Country [31] 0 0
Canada
State/province [31] 0 0
Saskatchewan
Country [32] 0 0
France
State/province [32] 0 0
Marseille
Country [33] 0 0
France
State/province [33] 0 0
Nice
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Valence
Country [36] 0 0
Germany
State/province [36] 0 0
Berlin
Country [37] 0 0
Germany
State/province [37] 0 0
Dresden
Country [38] 0 0
Germany
State/province [38] 0 0
Jena
Country [39] 0 0
Germany
State/province [39] 0 0
Osnabrück
Country [40] 0 0
Japan
State/province [40] 0 0
Fukuoka
Country [41] 0 0
Japan
State/province [41] 0 0
Kagoshima city
Country [42] 0 0
Japan
State/province [42] 0 0
Kyoto
Country [43] 0 0
Japan
State/province [43] 0 0
Nagoya-shi
Country [44] 0 0
Japan
State/province [44] 0 0
Obihiro
Country [45] 0 0
Japan
State/province [45] 0 0
Osaka-fu
Country [46] 0 0
Japan
State/province [46] 0 0
Osaka
Country [47] 0 0
Japan
State/province [47] 0 0
Shimotsuke
Country [48] 0 0
Japan
State/province [48] 0 0
Tokyo
Country [49] 0 0
Japan
State/province [49] 0 0
Tsu
Country [50] 0 0
Japan
State/province [50] 0 0
Yamanashi
Country [51] 0 0
Netherlands
State/province [51] 0 0
Bergen Op Zoom
Country [52] 0 0
Netherlands
State/province [52] 0 0
Breda
Country [53] 0 0
Netherlands
State/province [53] 0 0
Groningen
Country [54] 0 0
Netherlands
State/province [54] 0 0
Rotterdam
Country [55] 0 0
Poland
State/province [55] 0 0
Kraków
Country [56] 0 0
Poland
State/province [56] 0 0
Rzeszów
Country [57] 0 0
Poland
State/province [57] 0 0
Swidnik
Country [58] 0 0
Poland
State/province [58] 0 0
Wroclaw
Country [59] 0 0
Poland
State/province [59] 0 0
Lódz
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Glasgow
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 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?


Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://leopharmatrials.com/en/for-researchers


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Paller AS, Flohr C, Cork M, Bewley A, Blauvelt A, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03526861