ANB020-005: ANB020 in Moderate-to-Severe Atopic Dermatitis
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects with Moderate-to-Severe Atopic Dermatitis
IRAS ID
249132
Contact name
Professor Graham Ogg
Contact email
Sponsor organisation
AnaptysBio
Eudract number
2018-000331-27
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 11 months, 22 days
Research summary
This is a randomised, double-blind, placebo-controlled study to assess the efficacy (how well a drug works), safety and PK (pharmacokinetics) of ANB020 (the study drug) in adult patients with moderate to severe atopic dermatitis (eczema). Atopic dermatitis (AD) is one of the most common chronic inflammatory diseases of the skin that affects both children and adults.
The study will have a screening period of 4 weeks, a treatment period of 16 weeks and a safety follow-up period of 8 weeks.
There will be 5 groups of study participants receiving different doses of the study drug or placebo. A placebo looks like a medicine but contains no active ingredients. For every 5 study participants, 4 will receive ANB020 at different doses and 1 will receive placebo. There is an equal chance of being in any of the groups.
The study is “double-blind”. This means that neither the study participant nor the study doctor will know which study medication (ANB020 or placebo) the participant will receive.
Study participants will receive ANB020 or placebo, by subcutaneous (SC) injection on Day 1 (Week 0), Day 29 (Week 4), Day 57 (Week 8), and Day 85 (Week 12).
ANB020 is a monoclonal antibody and it is being developed for the treatment of atopic dermatitis (AD). Approximately 300 patients will be enrolled on the study worldwide with around 12 patients enrolled from the UK. The study sponsor is called Anaptys Bio, Inc.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0259
Date of REC Opinion
18 Sep 2018
REC opinion
Further Information Favourable Opinion