ESTUARY
Research type
Research Study
Full title
A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 48-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered as monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis.
IRAS ID
1009763
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi Pasteur Inc.
Eudract number
2023-508096-36
Clinicaltrials.gov Identifier
Research summary
Atopic dermatitis (AD) is a chronic inflammatory skin disease that causes itch and leaves red blotches on the skin. This disease can affect health, social functioning, well-being and quality of life. Available AD medicines are not always effective or suitable and may cause side effects. There is a need for new treatments.
This extension study evaluates the safety and treatment response of amlitelimab for AD, in participants who already completed a 24-week amlitelimab study (parent study) and if benefits can be maintained if the treatment frequency is continued, reduced, or stopped. For participants who did not have significant treatment response at the end of the parent study, this study will evaluate if benefit can be obtained by continuing or decreasing the interval between 2 doses. The study is a double-blind, placebo-controlled study with 2 periods: a treatment period (48 weeks), and a safety follow up period (16 weeks). Two different dosing intervals of amlitelimab will be compared to a placebo (dummy treatment). “Double-blind” means that neither the participant taking part, nor the study doctors know who is given the medicine or the placebo. This is done to make sure that the study results are not influenced in any way.
Amlitelimab works by blocking immune cells involved in the inflammation process. Amlitelimab or placebo is injected under the skin. The treatment is randomly chosen for each participant meaning determined by chance using a computer program. This works like flipping a coin. The placebo looks like the medicine being tested, but it does not have any real medicine in it. If necessary topical treatments may be given to control intolerable AD symptoms.
People 12 years and older with moderate to severe AD and have completed a 24-week parent study can take part in the study. Medical history of patients will be analaysed. If any of exclusion criteria are met, they cannot participate.REC name
London - Brent Research Ethics Committee
REC reference
24/LO/0260
Date of REC Opinion
11 Jul 2024
REC opinion
Further Information Favourable Opinion