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
Condition(s) studied
Investigational drug(s) / intervention(s)
Amlitelimab: Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous (SC)
Study summary
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.
Eligibility
Primary outcome measure(s)
- Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs) — Baseline up to end of study (EOS) (Week 284)
Percentage of participants who experienced TEAEs from baseline during the study - Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs) — Baseline up to EOS (Week 284)
Percentage of participants who experienced TESAEs from baseline during the study
Trial sites (174)
| Facility | City | Region | Status |
|---|---|---|---|
| Allervie Clinical Research - Birmingham- Site Number : 8400050 | Birmingham | Alabama | |
| Research Solutions of Arizona- Site Number : 8400020 | Litchfield Park | Arizona | |
| Dermatology Trial Associates- Site Number : 8400027 | Bryant | Arkansas | |
| University Dermatology Trials- Site Number : 8400052 | Newport Beach | California | |
| Children's Hospital Colorado - Aurora- Site Number : 8400041 | Aurora | Colorado | |
| IMMUNOe International Research Centers - Centennial- Site Number : 8400024 | Centennial | Colorado | |
| Renaissance Research and Medical Group- Site Number : 8400006 | Cape Coral | Florida | |
| Florida Pharmaceutical Research and Associates- Site Number : 8400018 | Miami | Florida | |
| Miami Clinical Research Tower- Site Number : 8400036 | Miami | Florida | |
| Florida Research Center- Site Number : 8400011 | Miami | Florida | |
| Clinical Research Trials of Florida- Site Number : 8400054 | Tampa | Florida | |
| Advanced Medical Research - Atlanta- Site Number : 8400044 | Atlanta | Georgia | |
| Georgia Skin & Cancer Clinic- Site Number : 8400048 | Savannah | Georgia | |
| Sneeze Wheeze & Itch Associates- Site Number : 8400002 | Normal | Illinois | |
| Kentucky Advanced Medical Research- Site Number : 8400014 | Murray | Kentucky | |
| The Derm Institute of West Michigan- Site Number : 8400043 | Caledonia | Michigan | |
| Michigan Dermatology Institute - Livonia- Site Number : 8401010 | Livonia | Michigan | |
| Michigan Dermatology Institute - Waterford- Site Number : 8400010 | Waterford | Michigan | |
| Dermatology Research Center of Oklahoma- Site Number : 8400035 | Tulsa | Oklahoma | |
| The Children's Hospital of Philadelphia- Site Number : 8400009 | Philadelphia | Pennsylvania | |
| Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400053 | San Antonio | Texas | |
| Private Practice - Dr. Marthe N. Dika- Site Number : 8400022 | Burlington | Wisconsin | |
| Investigational Site Number : 0320022 | General Pico | La Pampa Province | |
| Investigational Site Number : 0320006 | Rosario | Santa Fe Province | |
| Investigational Site Number : 0320007 | Rosario | Santa Fe Province | |
| Investigational Site Number : 0320008 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320001 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320003 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320002 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320004 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320009 | Buenos Aires | Argentina | |
| Investigational Site Number : 0320005 | Buenos Aires | Argentina | |
| Investigational Site Number : 0360002 | Kogarah | New South Wales | |
| Investigational Site Number : 0360001 | Sydney | New South Wales | |
| Centro de Pesquisas da Clínica IBIS- Site Number : 0760002 | Salvador | Estado de Bahia | |
| Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022 | Curitiba | Paraná | |
| Pontifica Universidade Catolica do Parana- Site Number : 0760023 | Curitiba | Paraná | |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005 | Porto Alegre | Rio Grande do Sul | |
| Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008 | Ribeirão Preto | São Paulo | |
| Faculdade de Medicina do ABC- Site Number : 0760001 | Santo André | São Paulo |
+ 134 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05769777 on ClinicalTrials.gov ↗ ← All trials in South Korea