A Phase 2B Dose-ranging study of REGN3500 in AD
Research type
Research Study
Full title
A Phase 2B, randomised, double-blind, placebo- controlled, parallel-group, dose-ranging study investigating the efficacy, safety, and Pharmacokinetic profiles of REGN3500 administered to adult patients with moderate-to-severe Atopic Dermatitis
IRAS ID
256223
Contact name
Pradnya Lokhande
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2018-001544-64
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
138118, IND Number
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Atopic dermatitis (AD), also known as atopic eczema, is a medical condition that causes the skin to become itchy, red, dry, thickened, and cracked. Atopic dermatitis typically improves and then worsens periodically and is often associated with other allergic disorders such as asthma, rhinitis and food allergy. Atopic dermatitis is typically treated with moisturisers and prescription ointments. There are treatments that can relieve the symptoms of atopic dermatitis, but the condition cannot be cured. Regeneron Pharmaceuticals, Inc. is developing REGN3500 for treatment of atopic dermatitis. This study is being conducted to determine the safety and effectiveness of 4 different doses of REGN3500 compared to the placebo in adult participants with moderate-to-severe AD who are intolerant of, or who are not adequately controlled with, topical treatment (applied to the skin).
REGN3500 has been previously tested in participants with asthma with no serious side effects. Based on the previous study results, REGN3500 is expected to be effective in treatment of AD.
This study is randomised meaning participants may receive any 1 of the 5 treatment regimens as listed below, double-blind(both the participant and the study doctor will not know which study drug is the participant receiving), placebo-controlled (a method of research in which an inactive substance (a placebo) is given to one group of participants, while the treatment ( study drug) being tested is given to another group, parallel-group (different groups/arms will receive different doses of the same drug and a placebo) , dose-ranging study(different doses of the same drug). The amount of study drug participants receive and the dosing interval will depend on their allocated treatment group.The 5 treatment groups/Arms in this study are:
Arm1:REGN3500 Subcutaneous (SC)
Arm2:REGN3500 SC
Arm3:REGN3500 SC
Arm4:REGN3500 SC
Arm5: Placebo SC
The treatment will be given in a form of sub-cutaneous injections (under the skin). Each participant will be a part of this study up to 41 weeks, including an up to 5-week screening period, 16-weeks treatment period and 20-weeks post-treatment follow-up period.
Approximately 300 participants will be randomised (60 per treatment group) from approximately 100 multinational study sites.REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/0562
Date of REC Opinion
29 May 2019
REC opinion
Further Information Favourable Opinion