Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
D2213C00001
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
1 other identifier
interventional
204
6 countries
57
Brief Summary
The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2015
Shorter than P25 for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2015
CompletedStudy Start
First participant enrolled
January 23, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 5, 2016
CompletedResults Posted
Study results publicly available
June 7, 2017
CompletedMay 23, 2018
April 1, 2018
10 months
January 5, 2015
May 11, 2017
April 24, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
EASI evaluates 4 natural anatomical regions for severity and extent of key disease signs and focuses on the key acute and chronic signs of inflammation (erythema, induration/papulation, excoriation, and lichenification). The maximum total score is 72, with higher values indicating more severe disease. The data presented here is Adjusted mean change after excluding the data from participants who took prohibited medications.
Baseline (Day 1) and Week 12
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
The IGA allows investigators to assess overall disease severity at one given time point and consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). A participant has IGA response if they achieve a score of 0 (clear) or 1 (almost clear) and at least a 2-grade reduction from baseline.
Week 12
Secondary Outcomes (8)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
From Study Drug Administration (Day 1) to Week 22
Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
From Study Drug Administration (Day 1) to Week 22
Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
Week 12
- +3 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORPlacebo matched to Tralokinumab will be administered subcutaneously to participants once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 1
EXPERIMENTALTralokinumab Dose 1 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 2
EXPERIMENTALTralokinumab Dose 2 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Tralokinumab Dose 3
EXPERIMENTALTralokinumab Dose 3 will be administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or human immunodeficiency virus
- Pregnant or breastfeeding
- History of cancer
- Previous receipt of tralokinumab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (57)
Research Site
Phoenix, Arizona, 85018, United States
Research Site
Rogers, Arkansas, 72758, United States
Research Site
Fremont, California, 94538, United States
Research Site
Fullerton, California, 92835, United States
Research Site
Los Angeles, California, 90045, United States
Research Site
Oceanside, California, 92056, United States
Research Site
Rancho Santa Margarita, California, 92688, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
Clearwater, Florida, 33759, United States
Research Site
Miami, Florida, 33144, United States
Research Site
Worcester, Massachusetts, 01605, United States
Research Site
Warren, Michigan, 48088, United States
Research Site
Berlin, New Jersey, 08009, United States
Research Site
Verona, New Jersey, 07044, United States
Research Site
New York, New York, 10029, United States
Research Site
Rochester, New York, 14625, United States
Research Site
Portland, Oregon, 97241, United States
Research Site
Charleston, South Carolina, 29414, United States
Research Site
Houston, Texas, 77004, United States
Research Site
Houston, Texas, 77056, United States
Research Site
Pflugerville, Texas, 78660, United States
Research Site
San Antonio, Texas, 78218, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Norfolk, Virginia, 23507, United States
Research Site
East Melbourne, 3002, Australia
Research Site
Kogarah, 02217, Australia
Research Site
Liverpool, 2170, Australia
Research Site
Sydney, 02010, Australia
Research Site
Woolloongabba, 04102, Australia
Research Site
Surrey, British Columbia, V3V 0C6, Canada
Research Site
Courtice, Ontario, L1E 3C3, Canada
Research Site
Markham, Ontario, L3P1X2, Canada
Research Site
Peterborough, Ontario, K9J 5K2, Canada
Research Site
Waterloo, Ontario, N2J 1C4, Canada
Research Site
Windsor, Ontario, N8W 5L7, Canada
Research Site
Berlin, 10117, Germany
Research Site
Bochum, 44803, Germany
Research Site
Dresden, 01307, Germany
Research Site
Dülmen, 48249, Germany
Research Site
Frankfurt am Main, 60590, Germany
Research Site
Hanover, 30625, Germany
Research Site
München, 80337, Germany
Research Site
Münster, 48149, Germany
Research Site
Stuttgart-Weilimdorf, 70499, Germany
Research Site
Wuppertal, 42287, Germany
Research Site
Nakano, 164-0001, Japan
Research Site
Shibuya-ku, 150-0034, Japan
Research Site
Shinjuku-ku, 160-0004, Japan
Research Site
Shinjuku-ku, 160-0023, Japan
Research Site
Shinjuku-ku, 169-0075, Japan
Research Site
Yokohama, 220-0073, Japan
Research Site
Katowice, 40-611, Poland
Research Site
Lodz, 90-436, Poland
Research Site
Szczecin, 70-332, Poland
Research Site
Warsaw, 04-141, Poland
Research Site
Wroclaw, 50-368, Poland
Research Site
Wroclaw, 51-318, Poland
Related Publications (2)
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.
PMID: 33333295DERIVEDWollenberg 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.
PMID: 29906525DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rene van der Merwe
- Organization
- MedImmune, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2015
First Posted
January 27, 2015
Study Start
January 23, 2015
Primary Completion
November 27, 2015
Study Completion
February 5, 2016
Last Updated
May 23, 2018
Results First Posted
June 7, 2017
Record last verified: 2018-04