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
Public ClinicalTrials.gov record NCT06407934. 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, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group 52-week Extension Study to Evaluate the Treatment Response and Safety of Two Amlitelimab Dose Regimens Administered by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing 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).
Study identification
- NCT ID
- NCT06407934
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,541 participants
Conditions and interventions
Conditions
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
- May 8, 2024 (Actual)
- Primary completion
- Jun 10, 2026 (Actual)
- Completion
- Mar 17, 2027 (Estimated)
- Last update posted
- Jul 10, 2026
2024 – 2027
United States locations
- U.S. sites
- 82
- U.S. states
- 28
- U.S. cities
- 70
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham | Alabama | 35244 | — |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | 85260 | — |
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale | Arizona | 85260 | — |
| Eclipse Clinical Research- Site Number : 8401158 | Tucson | Arizona | 85745 | — |
| Johnson Dermatology- Site Number : 8401076 | Fort Smith | Arkansas | 72916 | — |
| Encino Research Center- Site Number : 8401042 | Encino | California | 91436 | — |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley | California | 92708 | — |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | — |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach | California | 92647 | — |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette | California | 94549 | — |
| Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 | Lomita | California | 90717 | — |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles | California | 90045 | — |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | 90057 | — |
| Northridge Clinical Trials - Northridge- Site Number : 8401080 | Northridge | California | 91325 | — |
| Cura Clinical Research - Oxnard- Site Number : 8401142 | Oxnard | California | 93030 | — |
| Southern California Dermatology- Site Number : 8401043 | Santa Ana | California | 92701 | — |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | 90404 | — |
| UConn Health - Farmington- Site Number : 8401115 | Farmington | Connecticut | 06030 | — |
| Pediatric Skin Research- Site Number : 8401198 | Coral Gables | Florida | 33146 | — |
| St. Jude Clinical Research- Site Number : 8401287 | Doral | Florida | 33172 | — |
| Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286 | Fort Myers | Florida | 33919 | — |
| Direct Helpers Research Center- Site Number : 8401056 | Hialeah | Florida | 33012 | — |
| Encore Medical Research - Hollywood- Site Number : 8401030 | Hollywood | Florida | 33024 | — |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | 33126 | — |
| Acevedo Clinical Research Associates- Site Number : 8401088 | Miami | Florida | 33142 | — |
| Florida International Research Center- Site Number : 8401091 | Miami | Florida | 33173 | — |
| Miami Dermatology and Laser Research - Miami - Southwest 87th Avenue- Site Number : 8401086 | Miami | Florida | 33173 | — |
| Anchor Medical Research- Site Number : 8401300 | Miami | Florida | 33176 | — |
| Savin Medical Group - Miami Lakes- Site Number : 8401085 | Miami Lakes | Florida | 33014 | — |
| Nuline Clinical Trial Center- Site Number : 8401161 | Pompano Beach | Florida | 33060 | — |
| Global Clinical Professionals (GCP)- Site Number : 8401045 | St. Petersburg | Florida | 33705 | — |
| Clinical Research Trials of Florida- Site Number : 8401023 | Tampa | Florida | 33607 | — |
| AllerVie Clinical Research - Columbus- Site Number : 8401104 | Columbus | Georgia | 31904 | — |
| Cleaver Medical Group- Site Number : 8401138 | Dawsonville | Georgia | 30534 | — |
| First Georgia Physician Group- Site Number : 8401190 | Fayetteville | Georgia | 30214 | — |
| Skin Care Physicians of Georgia - Macon- Site Number : 8401034 | Macon | Georgia | 31217 | — |
| Javara Research - Thomasville- Site Number : 8401189 | Thomasville | Georgia | 31792 | — |
| Rophe Adult & Pediatric Medicine- Site Number : 8401289 | Union City | Georgia | 30291 | — |
| 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 | — |
| Skin Sciences- Site Number : 8401039 | Louisville | Kentucky | 40217 | — |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | — |
| BRCR Global Gretna- Site Number : 8401243 | Gretna | Louisiana | 70053 | — |
| Velocity Clinical Research - Lafayette- Site Number : 8401152 | Lafayette | Louisiana | 70508 | — |
| MetroBoston Clinical Partners - Brighton- Site Number : 8401128 | Brighton | Massachusetts | 02135 | — |
| Henry Ford Hospital- Site Number : 8401044 | Detroit | Michigan | 48202 | — |
| Revival Research Institute - Troy- Site Number : 8401012 | Troy | Michigan | 48084 | — |
| Oakland Medical Center- Site Number : 8401116 | Troy | Michigan | 48085 | — |
| Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078 | Ypsilanti | Michigan | 48197 | — |
| SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058 | Ridgeland | Mississippi | 39157 | — |
| Skin Specialists- Site Number : 8401068 | Omaha | Nebraska | 68144 | — |
| Jubilee Clinical Research- Site Number : 8401054 | Las Vegas | Nevada | 89106 | — |
| Care Access - Hoboken- Site Number : 8401132 | Hoboken | New Jersey | 07030 | — |
| The University of New Mexico- Site Number : 8401263 | Albuquerque | New Mexico | 87106 | — |
| 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 | — |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | New York | New York | 10075 | — |
| OptiSkin- Site Number : 8401163 | New York | New York | 10128 | — |
| AXIS Clinicals - Fargo- Site Number : 8401196 | Fargo | North Dakota | 58103 | — |
| Bexley Dermatology Research- Site Number : 8401051 | Bexley | Ohio | 43209 | — |
| Apex Clinical Research Center- Site Number : 8401237 | Mayfield Heights | Ohio | 44124 | — |
| Oregon Medical Research Center- Site Number : 8401017 | Portland | Oregon | 97201 | — |
| Best Skin Research - Camp Hill- Site Number : 8401031 | Camp Hill | Pennsylvania | 17011 | — |
| Paddington Testing Company- Site Number : 8401041 | Philadelphia | Pennsylvania | 19103 | — |
| Clinical Research of Philadelphia- Site Number : 8401193 | Philadelphia | Pennsylvania | 19114 | — |
| Dermatology Associates of Plymouth Meeting- Site Number : 8401147 | Plymouth Meeting | Pennsylvania | 19462 | — |
| Columbia Dermatology & Aesthetics- Site Number : 8401166 | Columbia | South Carolina | 29212 | — |
| Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8401225 | Greenville | South Carolina | 29607 | — |
| Health Concepts- Site Number : 8401059 | Rapid City | South Dakota | 57702 | — |
| Arlington Research Center- Site Number : 8401248 | Arlington | Texas | 76011 | — |
| Dermatology Treatment and Research Center- Site Number : 8401164 | Dallas | Texas | 75230 | — |
| Derm Texas- Site Number : 8401217 | Dallas | Texas | 75235 | — |
| Prolato Clinical Research Center- Site Number : 8401209 | Houston | Texas | 77054 | — |
| SMS Clinical Research- Site Number : 8401182 | Mesquite | Texas | 75149 | — |
| Synapse Clinical Research - Missouri City- Site Number : 8401148 | Missouri City | Texas | 77459 | — |
| Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8401131 | San Antonio | Texas | 78218 | — |
| Stryde Research - Epiphany Dermatology- Site Number : 8401185 | Southlake | Texas | 76092 | — |
| Complete Dermatology - Sugar Land- Site Number : 8401061 | Sugar Land | Texas | 77479 | — |
| Tanner Clinic - Layton Antelope A- Site Number : 8401151 | Layton | Utah | 84041 | — |
| Care Access - Arlington- Site Number : 8401134 | Arlington | Virginia | 22206 | — |
| Virginia Dermatology & Skin Cancer Center- Site Number : 8401047 | Norfolk | Virginia | 23502 | — |
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 242 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06407934, 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 Jul 10, 2026 · Synced Oct 19, 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 public registry record, listed eligibility criteria, and available contact information for NCT06407934 live on ClinicalTrials.gov.