Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Public ClinicalTrials.gov record NCT05769777. 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
An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab 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 single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 284 weeks, including: * A screening period of up to 2 to 4 weeks * An open label treatment period of up to 268 weeks (approximately 5 years) * A post-treatment safety follow-up period of at least 20 weeks after the last dose administration (last IMP administration at Week 264) The planned number of visits will be 35 visits.
Study identification
- NCT ID
- NCT05769777
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 999 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
- Apr 3, 2023 (Actual)
- Primary completion
- Jun 11, 2031 (Estimated)
- Completion
- Jun 11, 2031 (Estimated)
- Last update posted
- Apr 23, 2026
2023 – 2031
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Allervie Clinical Research - Birmingham- Site Number : 8400050 | Birmingham | Alabama | 35209 | — |
| Research Solutions of Arizona- Site Number : 8400020 | Litchfield Park | Arizona | 85340 | — |
| Dermatology Trial Associates- Site Number : 8400027 | Bryant | Arkansas | 72022 | — |
| University Dermatology Trials- Site Number : 8400052 | Newport Beach | California | 92660 | — |
| Children's Hospital Colorado - Aurora- Site Number : 8400041 | Aurora | Colorado | 80045 | — |
| IMMUNOe International Research Centers - Centennial- Site Number : 8400024 | Centennial | Colorado | 80112 | — |
| Renaissance Research and Medical Group- Site Number : 8400006 | Cape Coral | Florida | 33991 | — |
| Florida Pharmaceutical Research and Associates- Site Number : 8400018 | Miami | Florida | 33143 | — |
| Miami Clinical Research Tower- Site Number : 8400036 | Miami | Florida | 33155 | — |
| Florida Research Center- Site Number : 8400011 | Miami | Florida | 33174 | — |
| Clinical Research Trials of Florida- Site Number : 8400054 | Tampa | Florida | 33607 | — |
| Advanced Medical Research - Atlanta- Site Number : 8400044 | Atlanta | Georgia | 30342 | — |
| Georgia Skin & Cancer Clinic- Site Number : 8400048 | Savannah | Georgia | 31419 | — |
| Sneeze Wheeze & Itch Associates- Site Number : 8400002 | Normal | Illinois | 61761 | — |
| Kentucky Advanced Medical Research- Site Number : 8400014 | Murray | Kentucky | 42071 | — |
| The Derm Institute of West Michigan- Site Number : 8400043 | Caledonia | Michigan | 49316 | — |
| Michigan Dermatology Institute - Livonia- Site Number : 8401010 | Livonia | Michigan | 48152 | — |
| Michigan Dermatology Institute - Waterford- Site Number : 8400010 | Waterford | Michigan | 48328 | — |
| Dermatology Research Center of Oklahoma- Site Number : 8400035 | Tulsa | Oklahoma | 74132 | — |
| The Children's Hospital of Philadelphia- Site Number : 8400009 | Philadelphia | Pennsylvania | 19104 | — |
| Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053 | San Antonio | Texas | 78218 | — |
| Private Practice - Dr. Marthe N. Dika- Site Number : 8400022 | Burlington | Wisconsin | 53105 | — |
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 152 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05769777, 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 Apr 23, 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 NCT05769777 live on ClinicalTrials.gov.