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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02347176




Registration number
NCT02347176
Ethics application status
Date submitted
5/01/2015
Date registered
27/01/2015
Date last updated
23/05/2018

Titles & IDs
Public title
Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Scientific title
A Phase 2b, Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Tralokinumab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis
Secondary ID [1] 0 0
D2213C00001
Universal Trial Number (UTN)
Trial acronym
D2213C00001
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
Other interventions - Placebo
Treatment: Other - Tralokinumab Dose 1
Treatment: Other - Tralokinumab Dose 2
Treatment: Other - Tralokinumab Dose 3

Placebo comparator: Placebo - Placebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.

Experimental: Tralokinumab Dose 1 - Tralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Experimental: Tralokinumab Dose 2 - Tralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.

Experimental: Tralokinumab Dose 3 - Tralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.


Other interventions: Placebo
Subcutaneous injection with placebo

Treatment: Other: Tralokinumab Dose 1
Subcutaneous injection with tralokinumab

Treatment: Other: Tralokinumab Dose 2
Subcutaneous injection with tralokinumab

Treatment: Other: Tralokinumab Dose 3
Subcutaneous injection with tralokinumab
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
Timepoint [1] 0 0
Baseline (Day 1) and Week 12
Primary outcome [2] 0 0
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Response of 0 (Clear) or 1 (Almost Clear) and at Least a 2-Grade Reduction From Baseline at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [1] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Timepoint [1] 0 0
From Study Drug Administration (Day 1) to Week 22
Secondary outcome [2] 0 0
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
Timepoint [2] 0 0
From Study Drug Administration (Day 1) to Week 22
Secondary outcome [3] 0 0
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
Timepoint [3] 0 0
From Study Drug Administration (Day 1) to Week 22
Secondary outcome [4] 0 0
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
Timepoint [4] 0 0
From Study Drug Administration (Day 1) to Week 22
Secondary outcome [5] 0 0
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Timepoint [5] 0 0
Week 12
Secondary outcome [6] 0 0
Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
Timepoint [6] 0 0
Baseline (Day 1) and Week 12
Secondary outcome [7] 0 0
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
Timepoint [8] 0 0
Baseline (Day 1) and Week 12

Eligibility
Key inclusion criteria
* Physician diagnosis of atopic dermatitis for greater than (>) 1 year
* Atopic dermatitis involvement of greater than or equal to (>=) 10 percent (%) body surface area
* EASI score of >= 12
* SCORAD of >= 25
* IGA score of >= 3
* Effective birth control in line with protocol details
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of anaphylaxis following any biologic therapy
* Hepatitis B, C or human immunodeficiency virus
* Pregnant or breastfeeding
* History of cancer
* Previous receipt of tralokinumab

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
23/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/02/2016
Sample size
Target
Accrual to date
Final
204
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment hospital [2] 0 0
Research Site - Kogarah
Recruitment hospital [3] 0 0
Research Site - Liverpool
Recruitment hospital [4] 0 0
Research Site - Sydney
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
02217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
02010 - Sydney
Recruitment postcode(s) [5] 0 0
04102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Bochum
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Dülmen
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt/Main
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Munchen
Country [22] 0 0
Germany
State/province [22] 0 0
Münster
Country [23] 0 0
Germany
State/province [23] 0 0
Stuttgart-Weilimdorf
Country [24] 0 0
Germany
State/province [24] 0 0
Wuppertal
Country [25] 0 0
Japan
State/province [25] 0 0
Nakano-ku
Country [26] 0 0
Japan
State/province [26] 0 0
Shibuya-ku
Country [27] 0 0
Japan
State/province [27] 0 0
Shinjuku-ku
Country [28] 0 0
Japan
State/province [28] 0 0
Yokohama-shi
Country [29] 0 0
Poland
State/province [29] 0 0
Katowice
Country [30] 0 0
Poland
State/province [30] 0 0
Szczecin
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw
Country [33] 0 0
Poland
State/province [33] 0 0
Lódz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedImmune LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
Trial website
https://clinicaltrials.gov/study/NCT02347176
Trial related presentations / publications
Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, Rippon S, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021 May;126(5):576-583.e4. doi: 10.1016/j.anai.2020.12.004. Epub 2020 Dec 15.
Wollenberg A, Howell MD, Guttman-Yassky E, Silverberg JI, Kell C, Ranade K, Moate R, van der Merwe R. Treatment of atopic dermatitis with tralokinumab, an anti-IL-13 mAb. J Allergy Clin Immunol. 2019 Jan;143(1):135-141. doi: 10.1016/j.jaci.2018.05.029. Epub 2018 Jun 12.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02347176