A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Official title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Study identification

NCT ID

NCT06241118

Recruitment status

Recruiting

Study type

Interventional

Phase

Phase 3

Lead sponsor

Sanofi

Industry

Enrollment

636 participants

Conditions and interventions

Eligibility (public fields only)

Age range

12 Years and older

Sex

All

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Feb 28, 2024

Primary completion

Sep 29, 2027

Completion

Sep 28, 2028

Last update posted

May 7, 2026

2024 – 2028

United States locations

U.S. sites

42

U.S. states

25

U.S. cities

38

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 105 non-U.S. sites.