A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
Public ClinicalTrials.gov record NCT06130566. 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 Monotherapy 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 parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. 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
- NCT06130566
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 601 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
- Nov 7, 2023
- Primary completion
- Jul 22, 2025
- Completion
- Nov 12, 2025
- Last update posted
- Jul 21, 2026
2023 – 2025
United States locations
- U.S. sites
- 42
- U.S. states
- 19
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale | Arizona | 85260 | — |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley | California | 92708 | — |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | 94538 | — |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette | California | 94549 | — |
| Carbon Health - North Hollywood - NoHo West- Site Number : 8401218 | North Hollywood | California | 91606 | — |
| Northridge Clinical Trials - Northridge- Site Number : 8401080 | Northridge | California | 91325 | — |
| 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- Site Number : 8401030 | Hollywood | Florida | 33021 | — |
| Florida International Research Center- Site Number : 8401091 | Miami | Florida | 33173 | — |
| Miami Dermatology and Laser Research- Site Number : 8401086 | Miami | Florida | 33173 | — |
| Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035 | Orlando | Florida | 32806 | — |
| Cleaver Medical Group Dermatology- Site Number : 8401139 | Cumming | Georgia | 30040 | — |
| 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 | — |
| Skin Sciences- Site Number : 8401039 | Louisville | Kentucky | 40217 | — |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | — |
| MedPharmics - Lafeyette- Site Number : 8401152 | Lafayette | Louisiana | 70508 | — |
| Massachusetts General Hospital- Site Number : 8401192 | Boston | Massachusetts | 02114 | — |
| Metro Boston Clinical Partners- Site Number : 8401128 | Needham | Massachusetts | 02492 | — |
| Revival Research - Doral- Site Number : 8401012 | Dearborn | Michigan | 33122 | — |
| Henry Ford Hospital- Site Number : 8401044 | Detroit | Michigan | 48202 | — |
| SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058 | Ridgeland | Mississippi | 39157 | — |
| MediSearch Clinical Trials- Site Number : 8401140 | Saint Joseph | Missouri | 64506 | — |
| Somnos Clinical Research- Site Number : 8401203 | Lincoln | Nebraska | 68510 | — |
| Universal Dermatology- Site Number : 8401224 | Fairport | New York | 14450 | — |
| Sadick Research Group - New York - Park Avenue- Site Number : 8401050 | New York | New York | 10075 | — |
| CHEAR Center- Site Number : 8401123 | The Bronx | New York | 10459 | — |
| Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124 | Charlotte | North Carolina | 28277 | — |
| Oregon Medical Research Center- Site Number : 8401017 | Portland | Oregon | 97201 | — |
| Vial Health - DermDox Dermatology- 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 | — |
| Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225 | Greenville | South Carolina | 29607 | — |
| Dermatology Treatment and Research Center- Site Number : 8401164 | Dallas | Texas | 75230 | — |
| Skin Specialist of Addison- Site Number : 8401208 | Dallas | Texas | 75254 | — |
| Texas Dermatology and Laser Specialists- Site Number : 8401131 | San Antonio | Texas | 78218 | — |
| Stryde Research - Epiphany Dermatology- Site Number : 8401185 | Southlake | Texas | 76092 | — |
| Springville Dermatology - Springville- Site Number : 8401106 | Springville | Utah | 84663 | — |
| 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 106 non-U.S. sites.
Recently updated Dermatitis Atopic trials
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06130566, 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 21, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06130566 live on ClinicalTrials.gov.