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

Active, not recruiting · Phase 2 · NCT05769777

Conditions: Dermatitis Atopic

Research payments reported, 2025: $1.4M
U.S. investigators named: 28
Sites paid: 28
Planned or actual enrollment: 999

About the trial

Sponsor: Sanofi
Tested: Amlitelimab (drug)
Dates: Started 2023-04-03; completion 2031-06-11
Results posted: Not yet

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.

From ClinicalTrials.gov, last updated 2026-04-23. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $1.4M in research payments for this study in 2025 (199 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.

At a glance

About the trial

Industry funding

U.S. investigators named on this study

Sites paid to run it