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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
NCT06241118 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06241118
The ClinicalTrials.gov registry entry for NCT06241118 describes a study currently listed as 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 390 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 4 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: NCT06241118 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06241118?
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 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.
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