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 (COAST 2)
Public ClinicalTrials.gov record NCT06181435. 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, Parallelgroup, 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
- NCT06181435
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 589 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
- Dec 21, 2023 (Actual)
- Primary completion
- Nov 25, 2025 (Actual)
- Completion
- Mar 12, 2026 (Actual)
- Last update posted
- Aug 13, 2026
2023 – 2026
United States locations
- U.S. sites
- 43
- U.S. states
- 21
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | 85260 | — |
| Eclipse Clinical Research- Site Number : 8401158 | Tucson | Arizona | 85745 | — |
| Torrance Clinical Research- Site Number : 8401027 | Lomita | California | 90717 | — |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles | California | 90045 | — |
| Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079 | Mission Viejo | California | 92691 | — |
| Cura Clinical Research - Oxnard- Site Number : 8401142 | Oxnard | California | 93030 | — |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | 90404 | — |
| University of Connecticut Health Center- Site Number : 8401115 | Farmington | Connecticut | 06032 | — |
| Pediatric Skin Research- Site Number : 8401198 | Coral Gables | Florida | 33146 | — |
| Skin Care Research - Hollywood- Site Number : 8401071 | Hollywood | Florida | 33021 | — |
| Savin Medical Group - Miami- Site Number : 8401085 | Miami | Florida | 33126 | — |
| Anchor Medical Research- Site Number : 8401300 | Miami | Florida | 33176 | — |
| Accel Research - Nona Pediatric Center- Site Number : 8401081 | Orlando | Florida | 32829 | — |
| Nuline Clinical Trial Center- Site Number : 8401161 | Pompano Beach | Florida | 33060 | — |
| Clinical Research Trials of Florida- Site Number : 8401023 | Tampa | Florida | 33607 | — |
| AllerVie Clinical Research - Columbus- Site Number : 8401104 | Columbus | Georgia | 31904 | — |
| First Georgia Physician Group- Site Number : 8401190 | Fayetteville | Georgia | 30214 | — |
| Access Dermatology- Site Number : 8401296 | Bowling Green | Kentucky | 42104 | — |
| MedPharmics - Covington- Site Number : 8401137 | Covington | Louisiana | 70433 | — |
| Care Access Research - Marriottsville- Site Number : 8401126 | Marriottsville | Maryland | 21104 | — |
| Tufts Medical Center Site Number : 8401201 | Boston | Massachusetts | 02111 | — |
| University Of Mississippi Medical Center- Site Number : 8401184 | Jackson | Mississippi | 39216 | — |
| Care Access - Hoboken- Site Number : 8401132 | Hoboken | New Jersey | 07030 | — |
| University of New Mexico Comprehensive Cancer Center- Site Number : 8401263 | Albuquerque | New Mexico | 87102 | — |
| OmeraNY- Site Number : 8401156 | Brooklyn | New York | 11220 | — |
| Equity Medical- Site Number : 8401239 | New York | New York | 10023 | — |
| Montefiore Medical Center - Moses Campus- Site Number : 8401150 | The Bronx | New York | 10467 | — |
| Red River Research Partners- Site Number : 8401196 | Fargo | North Dakota | 58103 | — |
| Bexley Dermatology Research- Site Number : 8401051 | Bexley | Ohio | 43209 | — |
| Velocity Clinical Research - Springdale- Site Number : 8401153 | Cincinnati | Ohio | 45246 | — |
| Dermatology Associates of Plymouth Meeting- Site Number : 8401147 | Plymouth Meeting | Pennsylvania | 19462 | — |
| PEAK Research- Site Number : 8401083 | Upper Saint Clair | Pennsylvania | 15241 | — |
| Columbia Dermatology & Aesthetics- Site Number : 8401166 | Columbia | South Carolina | 29212 | — |
| Health Concepts- Site Number : 8401059 | Rapid City | South Dakota | 57702 | — |
| Arlington Research Center- Site Number : 8401248 | Arlington | Texas | 76011 | — |
| Derm Texas- Site Number : 8401217 | Dallas | Texas | 75235 | — |
| Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063 | Houston | Texas | 77004 | — |
| Prolato Clinical Research Center- Site Number : 8401209 | Houston | Texas | 77054 | — |
| Sienna Dermatology- Site Number : 8401148 | Missouri City | Texas | 77459 | — |
| Progressive Clinical Research - San Antonio- Site Number : 8401016 | San Antonio | Texas | 78229 | — |
| Advanced Research Institute - Odgen- Site Number : 8401057 | Ogden | Utah | 84405 | — |
| Care Access - Arlington- Site Number : 8401134 | Arlington | Virginia | 22206 | — |
| Velocity Clinical Research - Hampton- Site Number : 8401154 | Hampton | Virginia | 23666 | — |
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 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06181435, 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 13, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06181435 live on ClinicalTrials.gov.