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NCT06407934 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Dermatitis, Atopic, sponsored by Sanofi.
- Active
- Registry status
- Phase 3
- Development phase
- 1,541
- Enrollment target
- 20
- Study locations
NCT06407934: Active Phase 3 study of Dermatitis, Atopic, sponsored by Sanofi.
NCT06407934 is a Phase 3 study of Dermatitis, Atopic that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 1,541 participants, above the 344-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (348% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06407934, a Phase 3 study of Dermatitis, Atopic, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,541 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who received amlitelimab dose 1 in the parent studies (EFC17559 \[COAST-1\], EFC17560 \[COAST 2\], EFC17561 \[SHORE\]) and were responders can maintain their response either remaining at dose 1 or switching to dose 2 of amlitelimab compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY). The total treatment duration will be up to 52 weeks. The total number of visits will be up to 15 visits (or 14 visits for those entering LTS17367 \[RIVER-AD\] study).
Primary Outcome
Clinical response is defined as having vIGA-AD 0 or 1. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^. The validated Investigator Global Assessment scale for atopic dermatitis (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). The Eczema Area and Severity Index (EASI) is an Investigator-assessed validated tool used to measure the extent (a
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Amlitelimab
Study Locations (20)
California
- Encino Research Center- Site Number : 8401042 - Encino
- First OC Dermatology- Site Number : 8401025 - Fountain Valley
- Center for Dermatology Clinical Research- Site Number : 8401018 - Fremont
- Marvel Clinical Research- Site Number : 8401102 - Huntington Beach
- Sunwise Clinical Research- Site Number : 8401022 - Lafayette
- Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 - Lomita
- Dermatology Research Associates - Los Angeles- Site Number : 8401092 - Los Angeles
- LA Universal Research Center- Site Number : 8401064 - Los Angeles
- Northridge Clinical Trials - Northridge- Site Number : 8401080 - Northridge
- Cura Clinical Research - Oxnard- Site Number : 8401142 - Oxnard
- Southern California Dermatology- Site Number : 8401043 - Santa Ana
- Clinical Science Institute- Site Number : 8401028 - Santa Monica
Arizona
- Center for Dermatology and Plastic Surgery- Site Number : 8401119 - Scottsdale
- Scottsdale Clinical Trials- Site Number : 8401149 - Scottsdale
- Eclipse Clinical Research- Site Number : 8401158 - Tucson
Florida
- Pediatric Skin Research- Site Number : 8401198 - Coral Gables
- St. Jude Clinical Research- Site Number : 8401287 - Doral
Alabama
- Cahaba Dermatology & Skin Health Center- Site Number : 8401066 - Birmingham
Arkansas
- Johnson Dermatology- Site Number : 8401076 - Fort Smith
Connecticut
- UConn Health - Farmington- Site Number : 8401115 - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,541 participants |
| Start Date | 2024-05-08 |
| Est. Completion | 2027-03-17 |
| Phase | Phase 3 |
What the registry record for NCT06407934 still lists
NCT06407934 is an interventional study that assigns participants to a tested intervention. Its 1,541 participants enrollment target places it among the larger protocols in the corpus, above the 344-participant average among 29 other Dermatitis, Atopic trials with a reported enrollment target (348% higher).
The record links to 1 condition, with Dermatitis, Atopic appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06407934 names 20 study sites across 6 states, led by California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT06407934 about?
NCT06407934 is a clinical study titled "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". This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The main objective of this study is to evaluate if those participants who recei...
What is the current status of trial NCT06407934?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,541 participants. The study started on 2024-05-08. Estimated completion is 2027-03-17.
What conditions does trial NCT06407934 study?
This clinical trial studies the following conditions: Dermatitis, Atopic.
What interventions are being tested in trial NCT06407934?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG).
Who is sponsoring clinical trial NCT06407934?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06407934 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06407934's enrollment target sits among peer trials
1,541 2nd of 29 the highest 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
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