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NCT06224348 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Dermatitis, Atopic, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 643
- Enrollment target
- 20
- Study locations
NCT06224348: Completed Phase 3 study of Dermatitis, Atopic, sponsored by Sanofi.
NCT06224348 is a Phase 3 study of Dermatitis, Atopic that has completed, run by Sanofi. The registered enrollment target is 643 participants, above the 375-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06224348, a Phase 3 study of Dermatitis, Atopic, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 643 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 atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI). 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/or TCI. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600 (ESTUARY).
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 calcineurin inhibitors
Study Locations (20)
Florida
- Skin Care Research - Hollywood- Site Number : 8401071 - Hollywood
- Clever Medical Research- Site Number : 8401160 - Miami
- Acevedo Clinical Research Associates- Site Number : 8401088 - Miami
- Palm Springs Community Health Center- Site Number : 8401264 - Miami Lakes
- Global Clinical Professionals (GCP)- Site Number : 8401045 - St. Petersburg
- University of South Florida- Site Number : 8401070 - Tampa
- Avita Clinical Research- Site Number : 8401073 - Tampa
California
- Encino Research Center- Site Number : 8401042 - Encino
- Marvel Clinical Research- Site Number : 8401102 - Huntington Beach
- LA Universal Research Center- Site Number : 8401064 - Los Angeles
- Cura Clinical Research- Site Number : 8401141 - Palmdale
- Integrative Skin Science and Research- Site Number : 8401275 - Sacramento
- Southern California Dermatology- Site Number : 8401043 - Santa Ana
Louisiana
- BRCR Global Gretna- Site Number : 8401243 - Gretna
- Velocity Clinical Research - New Orleans- Site Number : 8401155 - New Orleans
Alabama
- Cahaba Dermatology & Skin Health Center- Site Number : 8401066 - Birmingham
Arkansas
- Johnson Dermatology- Site Number : 8401076 - Fort Smith
Georgia
- Cleaver Medical Group- Site Number : 8401138 - Dawsonville
Illinois
- NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038 - Skokie
Indiana
- Dawes Fretzin Clinical Research- Site Number : 8401015 - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2024-01-18 |
| Est. Completion | 2025-11-01 |
| Phase | Phase 3 |
What the finished NCT06224348 record still lists
NCT06224348 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (71% higher).
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.
NCT06224348 names 20 study sites across 8 states, led by Florida, California, Louisiana.
Frequently Asked Questions
What is clinical trial NCT06224348 about?
NCT06224348 is a clinical study titled "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". 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 atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticoste...
What is the current status of trial NCT06224348?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 643 participants. The study started on 2024-01-18. Estimated completion is 2025-11-01.
What conditions does trial NCT06224348 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT06224348?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG), Topical corticosteroids (DRUG), Topical calcineurin inhibitors (DRUG).
Who is sponsoring clinical trial NCT06224348?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06224348 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. 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 NCT06224348's enrollment target sits among peer trials
643 8th of 29 higher than 22 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 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
RECRUITING · Phase 3
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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
ACTIVE NOT RECRUITING · Phase 3
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