drugset / Trial / 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
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-04-03
- Primary completion
- 2031-06-11
- Completion
- 2031-06-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlitelimab | Monoclonal antibody | — | Subcutaneous |