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NCT06241118 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Dermatitis, Atopic, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 390
- Enrollment target
- 20
- Study locations
NCT06241118: Recruiting Phase 3 study of Dermatitis, Atopic, sponsored by Sanofi.
NCT06241118 is a Phase 3 study of Dermatitis, Atopic that is actively recruiting participants, run by Sanofi. The registered enrollment target is 390 participants, roughly in line with the 384-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06241118, a Phase 3 study of Dermatitis, Atopic, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 390 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).
Primary Outcome
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amlitelimab
- DRUG Topical corticosteroids
- DRUG Topical tacrolimus or pimecrolimus
Study Locations (20)
California
- Encino Research Center- Site Number : 8401042 - Encino
- Center for Dermatology Clinical Research- Site Number : 8401018 - Fremont
- Long Beach Clinical Trials- Site Number : 8401188 - Long Beach
- Dermatology Research Associates - Los Angeles- Site Number : 8401092 - Los Angeles
- LA Universal Research Center- Site Number : 8401064 - Los Angeles
- University Dermatology Trials- Site Number : 8401339 - Newport Beach
- Rady Children's Hospital- Site Number : 8401291 - San Diego
- Therapeutics Clinical Research- Site Number : 8401283 - San Diego
Florida
- Encore Medical Research of Boynton Beach- Site Number : 8401030 - Boynton Beach
- St. Jude Clinical Research- Site Number : 8401287 - Doral
- Apex Clinical Research - Jacksonville- Site Number : 8401332 - Jacksonville
- Global Clinical Professionals (GCP)- Site Number : 8401045 - St. Petersburg
- Avita Clinical Research- Site Number : 8401073 - Tampa
Illinois
- Northwestern University- Site Number : 8401285 - Chicago
- NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038 - Skokie
Alabama
- University of Alabama at Birmingham- Site Number : 8401267 - Birmingham
Arizona
- Center for Dermatology and Plastic Surgery- Site Number : 8401119 - Scottsdale
Arkansas
- Arkansas Dermatology - North Little Rock- Site Number : 8401244 - North Little Rock
Colorado
- Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245 - Wheat Ridge
Indiana
- Dawes Fretzin Clinical Research- Site Number : 8401015 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 390 participants |
| Start Date | 2024-02-29 |
| Est. Completion | 2026-09-14 |
| Phase | Phase 3 |
What NCT06241118 shows while recruiting
NCT06241118 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 384-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target.
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT06241118 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT06241118 about?
NCT06241118 is a clinical study titled "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". This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this ...
What is the current status of trial NCT06241118?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 390 participants. The study started on 2024-02-29. Estimated completion is 2026-09-14.
What conditions does trial NCT06241118 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT06241118?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG), Topical corticosteroids (DRUG), Topical tacrolimus or pimecrolimus (DRUG).
Who is sponsoring clinical trial NCT06241118?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06241118 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatitis, Atopic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06241118's enrollment target sits among peer trials
390 9th of 29 higher than 21 of 29 other Dermatitis, Atopic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatitis, Atopic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Treatment Response and Safety of Two Dose Regimens of Subcutaneous Amlitelimab Compared With Treatment Withdrawal in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
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Study of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
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Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
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Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
COMPLETED · Phase 3
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A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
COMPLETED · Phase 3
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