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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
NCT06407934 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06407934
The ClinicalTrials.gov registry entry for NCT06407934 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,541 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06407934 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06407934?
The interventions under investigation include: Placebo (DRUG), Amlitelimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06407934?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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