Clinical trial NCT02347176: Phase 2 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults With Atopic Dermatitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy and safety of tralokinumab in adults with atopic dermatitis


Eligibility criteria: 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

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

Primary outcomes:
measure: Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: 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
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From Study Drug Administration (Day 1) to Week 22
measure: Number of Participants With Vital Signs and Physical Examination Abnormalities Reported as Treatment Emergent Adverse Events
timeFrame: From Study Drug Administration (Day 1) to Week 22
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment Emergent Adverse Events
timeFrame: From Study Drug Administration (Day 1) to Week 22
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities Reported as Treatment Emergent Adverse Events
timeFrame: From Study Drug Administration (Day 1) to Week 22
measure: Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12
timeFrame: Week 12
measure: Absolute Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 12
timeFrame: Baseline (Day 1) and Week 12
measure: Adjusted Percentage of Participants Achieving 50 Percent (%) Reduction From Baseline in SCORAD at Week 12
timeFrame: Week 12
measure: Change From Baseline in Pruritus Numeric Rating Scale (NRS) (7-day Mean Score) at Week 12
timeFrame: Baseline (Day 1) and Week 12
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Rogers
country: United States
facility: Research Site
state: Arkansas
city: Fremont
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Oceanside
country: United States
facility: Research Site
state: California
city: Rancho Santa Margarita
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Warren
country: United States
facility: Research Site
state: Michigan
city: Berlin
country: United States
facility: Research Site
state: New Jersey
city: Verona
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Houston
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Pflugerville
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: East Melbourne
country: Australia
facility: Research Site
city: Kogarah
country: Australia
facility: Research Site
city: Liverpool
country: Australia
facility: Research Site
city: Sydney
country: Australia
facility: Research Site
city: Woolloongabba
country: Australia
facility: Research Site
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Courtice
country: Canada
facility: Research Site
state: Ontario
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Dülmen
country: Germany
facility: Research Site
city: Frankfurt/Main
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Stuttgart-Weilimdorf
country: Germany
facility: Research Site
city: Wuppertal
country: Germany
facility: Research Site
city: Nakano-ku
country: Japan
facility: Research Site
city: Shibuya-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.