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Clinical Trial Summary

This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD). The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (primary endpoint). Study details include: The study duration will be up to 36 weeks (for participants not entering the LTS17367 [RIVER-AD]). The screening period will be 2 to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 [RIVER-AD]).


Clinical Trial Description

The study duration will be up to 36 weeks ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06015308
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Can
Phone 800-633-1610
Email contact-us@sanofi.com
Status Recruiting
Phase Phase 2
Start date October 6, 2023
Completion date August 18, 2025

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