NCT05769777

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 901 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.

Conditions

• Dermatitis Atopic

Interventions

Type	Name	Description
DRUG	Amlitelimab	Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Timeline

• Start date: 2023-04-03
• Primary completion: 2031-06-11
• Completion: 2031-06-11
• First posted: 2023-03-15
• Last updated: 2026-04-08

Locations

175 sites across 25 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Czechia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study