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
Public ClinicalTrials.gov record NCT06224348. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT06224348
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 643 participants
Conditions and interventions
Conditions
Interventions
- Amlitelimab Drug
- Placebo Drug
- Topical corticosteroids Drug
- Topical calcineurin inhibitors Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 17, 2024
- Primary completion
- Aug 20, 2025
- Completion
- Oct 31, 2025
- Last update posted
- Aug 12, 2026
2024 – 2025
United States locations
- U.S. sites
- 40
- U.S. states
- 20
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham | Alabama | 35244 | — |
| Johnson Dermatology- Site Number : 8401076 | Fort Smith | Arkansas | 72916 | — |
| Encino Research Center- Site Number : 8401042 | Encino | California | 91436 | — |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach | California | 92647 | — |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | 90057 | — |
| Cura Clinical Research- Site Number : 8401141 | Palmdale | California | 93551 | — |
| Integrative Skin Science and Research- Site Number : 8401275 | Sacramento | California | 95815 | — |
| Southern California Dermatology- Site Number : 8401043 | Santa Ana | California | 92701 | — |
| Skin Care Research - Hollywood- Site Number : 8401071 | Hollywood | Florida | 33021 | — |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | 33126 | — |
| Acevedo Clinical Research Associates- Site Number : 8401088 | Miami | Florida | 33142 | — |
| Palm Springs Community Health Center- Site Number : 8401264 | Miami Lakes | Florida | 33016 | — |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33705 | — |
| University of South Florida- Site Number : 8401070 | Tampa | Florida | 33612 | — |
| Avita Clinical Research- Site Number : 8401073 | Tampa | Florida | 33613 | — |
| Cleaver Medical Group- Site Number : 8401138 | Dawsonville | Georgia | 30534 | — |
| NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038 | Skokie | Illinois | 60076 | — |
| Dawes Fretzin Clinical Research- Site Number : 8401015 | Indianapolis | Indiana | 46256 | — |
| BRCR Global Gretna- Site Number : 8401243 | Gretna | Louisiana | 70053 | — |
| Velocity Clinical Research - New Orleans- Site Number : 8401155 | New Orleans | Louisiana | 70119 | — |
| Oakland Medical Center- Site Number : 8401116 | Troy | Michigan | 48085 | — |
| Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078 | Ypsilanti | Michigan | 48197 | — |
| Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157 | Lee's Summit | Missouri | 64064 | — |
| Skin Specialists- Site Number : 8401068 | Omaha | Nebraska | 68144 | — |
| Jubilee Clinical Research- Site Number : 8401054 | Las Vegas | Nevada | 89106 | — |
| Allcutis Research - Portsmouth- Site Number : 8401082 | Portsmouth | New Hampshire | 03801 | — |
| Equity Medical- Site Number : 8401239 | New York | New York | 10023 | — |
| Icahn School of Medicine at Mount Sinai- Site Number : 8401129 | New York | New York | 10029 | — |
| OptiSkin- Site Number : 8401163 | New York | New York | 10128 | — |
| Apex Clinical Research Center- Site Number : 8401237 | Mayfield Heights | Ohio | 44124 | — |
| Essential Medical Research- Site Number : 8401183 | Tulsa | Oklahoma | 74137 | — |
| Vial Health - DermDox Dermatology- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | — |
| Clinical Research Center of the Carolinas- Site Number : 8401067 | Charleston | South Carolina | 29407 | — |
| SMS Clinical Research- Site Number : 8401182 | Mesquite | Texas | 75149 | — |
| Sienna Dermatology- Site Number : 8401148 | Missouri City | Texas | 77459 | — |
| Texas Dermatology and Laser Specialists- Site Number : 8401131 | San Antonio | Texas | 78218 | — |
| Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026 | San Antonio | Texas | 78258 | — |
| Complete Dermatology - Sugar Land- Site Number : 8401061 | Sugar Land | Texas | 77479 | — |
| Cope Family Medicine - Ogden Clinic- Site Number : 8401114 | Bountiful | Utah | 84010 | — |
| Tanner Clinic - Layton Antelope A- Site Number : 8401151 | Layton | Utah | 84041 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 127 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06224348, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 12, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06224348 live on ClinicalTrials.gov.