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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

NCT05769777 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 999

Last updated 2026-04-23

No results posted yet for this study

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

DRUG

Amlitelimab

Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-03
Primary Completion
2031-06-11
Completion
2031-06-11
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05769777 on ClinicalTrials.gov