Study of Tezepelumab in Moderate-to-Severe Atopic Dermatitis
Research type
Research Study
Full title
A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined with Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis
IRAS ID
254018
Contact name
Anthony Bewley
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2018-001997-52
Duration of Study in the UK
2 years, 1 months, 6 days
Research summary
This phase 2b study is designed to evaluate safety and efficacy of tezepelumab as
monotherapy and explore its efficacy as adjunct therapy in subjects with moderate-to-severe Atopic Dermatitis (AD). Part A is main study, evaluating tezepelumab as monotherapy; Part B evaluates tezepelumab as adjunctive therapy when combined with topical corticosteroids.
In Part A, two futility analyses are planned. If “not futile” for first analysis, enrollment of subjects in Part B will commence.
Eligible subjects will include adults with a clinical diagnosis of AD for at least 2 years, that affects ≥ 10% of body surface area.
Study will consist of a 28-day screening period, a 52-week treatment period, and 12-week safety follow-up period.
During screening, subjects must discontinue from all topical AD therapies, except approved moisturizers. Eligible subjects will be randomized 1:1:1:1 to receive 420 mg subcutaneous injection [SC] every 2 weeks [Q2W], 280 mg SC Q2W, 210 mg SC every 4 weeks [Q4W], or placebo. All subjects will receive a 420 mg SC dose (investigational product or placebo) as first dose. Thereafter, they will receive the appropriate dose depending on treatment group.
In Part B, subjects will be randomized 2:1 to receive 420 mg SC Q2W or placebo; both groups in Part B will be allowed to use topical corticosteroids.
Approx 240 subjects will be enrolled into Part A, approx. 60 into Part B.
Key study procedures include assessment of Investigator's Global Assessment, Eczema Area and Severity Index, SCORAD (Scoring of Atopic Dermatitis), and other measures of AD disease severity. Samples will be collected for Pharmacokinetic analysis and biomarker development. A safety follow-up will be conducted for 14 weeks after the final dose.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
18/SC/0682
Date of REC Opinion
18 Jan 2019
REC opinion
Further Information Favourable Opinion