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
Public ClinicalTrials.gov record NCT06241118. 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 (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment
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 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).
Study identification
- NCT ID
- NCT06241118
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 464 participants
Conditions and interventions
Conditions
Interventions
- Amlitelimab Drug
- Placebo Drug
- Topical corticosteroids Drug
- Topical tacrolimus or pimecrolimus 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
- Feb 28, 2024
- Primary completion
- Sep 29, 2027
- Completion
- Sep 28, 2028
- Last update posted
- Aug 26, 2026
2024 – 2028
United States locations
- U.S. sites
- 43
- U.S. states
- 25
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham- Site Number : 8401267 | Birmingham | Alabama | 35233 | — |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | 85260 | — |
| Arkansas Dermatology - North Little Rock- Site Number : 8401244 | North Little Rock | Arkansas | 72117 | — |
| Encino Research Center- Site Number : 8401042 | Encino | California | 91436 | — |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | — |
| Long Beach Clinical Trials- Site Number : 8401188 | Long Beach | California | 90806 | — |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles | California | 90045 | — |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | 90057 | — |
| University Dermatology Trials- Site Number : 8401339 | Newport Beach | California | 92660 | — |
| Rady Children's Hospital- Site Number : 8401291 | San Diego | California | 92123 | — |
| Therapeutics Clinical Research- Site Number : 8401283 | San Diego | California | 92123 | — |
| Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245 | Wheat Ridge | Colorado | 80033 | — |
| Encore Medical Research of Boynton Beach- Site Number : 8401030 | Boynton Beach | Florida | 33436 | — |
| St. Jude Clinical Research- Site Number : 8401287 | Doral | Florida | 33172 | — |
| Apex Clinical Research - Jacksonville- Site Number : 8401332 | Jacksonville | Florida | 32256 | — |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | 33126 | — |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33714 | — |
| Avita Clinical Research- Site Number : 8401073 | Tampa | Florida | 33613 | — |
| Northwestern University- Site Number : 8401285 | Chicago | Illinois | 60611 | — |
| NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8401038 | Skokie | Illinois | 60077 | — |
| Dawes Fretzin Clinical Research- Site Number : 8401015 | Indianapolis | Indiana | 46256 | — |
| Equity Medical - Bowling Green- Site Number : 8401296 | Bowling Green | Kentucky | 42104 | — |
| Tandem Clinical Research - Metairie- Site Number : 8401187 | Metairie | Louisiana | 70006 | — |
| University of Michigan Health System - Ann Arbor- Site Number : 8401290 | Ann Arbor | Michigan | 48109 | — |
| MI Skin Center- Site Number : 8401307 | Northville | Michigan | 48167 | — |
| Skin Specialists- Site Number : 8401068 | Omaha | Nebraska | 68144 | — |
| Schweiger Dermatology Group - East Windsor- Site Number : 8401338 | East Windsor | New Jersey | 08520 | — |
| The University of New Mexico- Site Number : 8401263 | Albuquerque | New Mexico | 87106 | — |
| Equity Medical- Site Number : 8401239 | New York | New York | 10023 | — |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | New York | New York | 10075 | — |
| Cincinnati Children's Hospital Medical Center- Site Number : 8401279 | Cincinnati | Ohio | 45229 | — |
| Oregon Health & Science University (OHSU)- Site Number : 8401247 | Portland | Oregon | 97239 | — |
| Paddington Testing Company- Site Number : 8401041 | Philadelphia | Pennsylvania | 19103 | — |
| Clinical Research of Philadelphia- Site Number : 8401193 | Philadelphia | Pennsylvania | 19114 | — |
| Medical University of South Carolina - Charleston - Jonathan Lucas Street- Site Number : 8401282 | Charleston | South Carolina | 29425 | — |
| Arlington Research Center- Site Number : 8401248 | Arlington | Texas | 76011 | — |
| McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8401288 | Bellaire | Texas | 77401 | — |
| Reveal Research Institute - Dallas- Site Number : 8401219 | Dallas | Texas | 75235 | — |
| Advanced Research Institute - Odgen (ARI - Ogden)- Site Number : 8401057 | Ogden | Utah | 84405 | — |
| Virginia Dermatology & Skin Cancer Center- Site Number : 8401047 | Norfolk | Virginia | 23502 | — |
| North Sound Dermatology- Site Number : 8401280 | Mill Creek | Washington | 98012 | — |
| Children's Wisconsin- Site Number : 8401246 | Milwaukee | Wisconsin | 53226 | — |
| Cheyenne Skin Clinic- Site Number : 8401234 | Cheyenne | Wyoming | 82009 | — |
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 107 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06241118, 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 26, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06241118 live on ClinicalTrials.gov.