DRI18180
Research type
Research Study
Full title
A Phase 2, randomized, double-blind, placebo controlled, parallel group, 3-arm, multinational, multicenter, proof-of-concept study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in adult participants with severe alopecia areata
IRAS ID
1009854
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi Pasteur Inc.
Research summary
This study is to evaluate the efficacy and safety of subcutaneous amlitelimab monotherapy compared with placebo in adult participants with severe alopecia areata. This study is taking place in 15 countries. It is planned to start in June 2024. Available medicines for alopecia areata are not always effective or suitable for all patients and may cause side effects, there is a need for new treatment. In this study, researchers want to check how safe and effective amlitelimab is in treating severe alopecia areata when injected under the skin. The study compares how effective and safe two different frequencies of the medicine (amlitelimab) are compared to a placebo (dummy treatment). People 18 years or older with severe alopecia areata (50% scalp hair loss or more) can participate. Two different frequencies of amlitelimab are being tested. Amlitelimab works by blocking cells involved in the inflammation process. Amlitelimab or placebo is injected under the skin (eg, abdomen, thigh, or upper arm). The treatment is randomly chosen for each participant meaning determined by chance using a computer program. The study contains 3 periods: enrolment period (also called screening period) (2 to 4 weeks), treatment period (36 weeks), and safety follow-up period (16 weeks). Participants may have the possibility to continue treatment with amlitelimab in another study at the end of treatment period. In that case, the current study duration will be up to 40 weeks. By participating in this study, it is possible that amlitelimab may improve severe alopecia areata more than usual treatment, it is not certain that people will directly benefit from participating. Amlitelimab has been well tolerated in other clinical studies, but has mostly been tested for other skin conditions. A placebo is used to better see the effect of the medicine being compared with having no medicine.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0294
Date of REC Opinion
27 Jun 2024
REC opinion
Further Information Favourable Opinion