Evaluate efficacy and safety of LEO 138559 in adults with moderate-to-severe AD
Research type
Research Study
Full title
A phase 2b, randomized, double-blind, placebo-controlled, multi-site, parallel-group, dose finding trial to evaluate the efficacy and safety of different doses of subcutaneously administered LEO 138559 in adult subjects with moderate-to-severe atopic dermatitis (AD).
IRAS ID
1007132
Contact name
Ana Tenreiro da Cruz
Contact email
Sponsor organisation
LEO Pharma A/S
Research summary
The purpose of this trial is to test different doses of the trial medicine (LEO 138559) at treating moderate to severe atopic dermatitis in adults. There will be 4 different doses, that will also be compared to a placebo (a dummy medicine that doesn't contain the active ingredient of LEO 138559). Each participant will be randomly assigned to one of the 4 doses of LEO 138559 or placebo. In all arms, injections of placebo may be used to mask the different doses. The trial will last up to 36 weeks, including a screening/washout period (up to 4 weeks), a treatment period (16 weeks), and a follow up period (16 weeks). The participants will visit the clinic 17 times. For the first 4 weeks of the treatment period, participants will visit the clinic every week. For the next 12 weeks of the treatment period, participants will visit the clinic every 2 weeks. For the 16 week follow up period, participants will visit the clinic every 4 weeks. The treatments will be given to the participants by staff at the clinic. They are given as an injection just under the skin. At each visit the doctor will check the participants atopic dermatitis and if they
have had any side effects. Participants will also complete an electronic diary every day about their atopic dermatitis and quality of life.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0136
Date of REC Opinion
19 Sep 2023
REC opinion
Further Information Favourable Opinion