Amlitelimab: Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Topical corticosteroids: Pharmaceutical form: Topical Route of administration: Topical
Topical calcineurin inhibitors: Pharmaceutical form: Topical Route of administration: Topical
Oral corticosteroids: Pharmaceutical form: Oral Route of administration: Oral
This is an open-label, Phase 2/Phase 3, long-term extension study for treatment of participants of previous amlitelimab clinical trials in moderate to severe atopic dermatitis.
The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated participants with moderate to severe atopic dermatitis (AD) who have previously been enrolled in an amlitelimab clinical trial. All participants will have visits during the treatment period every 4 weeks. Responder participants rolling over from EFC17599 and EFC17600, and responder participants enrolling through screening from DRI17366 will be initiated into drug withdrawal (with no drug administration) at LTS17367 baseline visit to monitor durability of treatment response. If these responder participants relapse during LTS17367, they will have treatment restored. Non-responder participants rolling over from EFC17599 or EFC17600, and non-responder participants enrolling through screening from DRI17366 will have treatment administration from LTS17367 baseline. Participants rolling over from DRI17366, SFY17915 and INT18404 will also have treatment administration from LTS17367 baseline.
Remote visits with home dosing are allowed for the purpose of study drug administration, when applicable. In the case of remote visit with home dosing, the participant or a caregiver may administer study drug after appropriate training. Alternatively, if needed, and based on the investigator's judgement, home visits with healthcare professional assistance or on-site study drug administration visits can be performed. Where participants discontinue amlitelimab permanently during LTS17367, safety follow up will be performed for a minimum of 140 days from the last amlitelimab administration.
| Facility | City | Region | Status |
|---|---|---|---|
| Allervie Clinical Research - Birmingham- Site Number : 8401101 | Birmingham | Alabama | |
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham | Alabama | |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale | Arizona | |
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale | Arizona | |
| Eclipse Clinical Research- Site Number : 8401158 | Tucson | Arizona | |
| Arkansas Research Trials- Site Number : 8401244 | North Little Rock | Arkansas | |
| Orange County Clinical Trials- Site Number : 8401271 | Anaheim | California | |
| Encino Research Center- Site Number : 8401042 | Encino | California | |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley | California | |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont | California | |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach | California | |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette | California | |
| Antelope Valley Clinical Trials- Site Number : 8401099 | Lancaster | California | |
| Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 | Lomita | California | |
| Long Beach Clinical Trials- Site Number : 8401188 | Long Beach | California | |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles | California | |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles | California | |
| University Dermatology Trials- Site Number : 8401339 | Newport Beach | California | |
| Cura Clinical Research - Oxnard- Site Number : 8401142 | Oxnard | California | |
| Southern California Dermatology- Site Number : 8401043 | Santa Ana | California | |
| Clinical Science Institute- Site Number : 8401028 | Santa Monica | California | |
| Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245 | Wheat Ridge | Colorado | |
| UConn Health - Farmington- Site Number : 8401115 | Farmington | Connecticut | |
| Encore Medical Research of Boynton Beach- Site Number : 8401030 | Boynton Beach | Florida | |
| Pediatric Skin Research- Site Number : 8401198 | Coral Gables | Florida | |
| St. Jude Clinical Research- Site Number : 8401287 | Doral | Florida | |
| Alliance for Multispeciality Research - Fort Myers- Site Number : 8401111 | Fort Myers | Florida | |
| Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286 | Fort Myers | Florida | |
| Direct Helpers Research Center- Site Number : 8401056 | Hialeah | Florida | |
| Doral Medical Research - Hialeah- Site Number : 8401094 | Hialeah | Florida | |
| Apex Clinical Research - Jacksonville- Site Number : 8401332 | Jacksonville | Florida | |
| Clever Medical Research- Site Number : 8401160 | Miami | Florida | |
| Miami Dermatology and Laser Research - Miami - South Miami Avenue- Site Number : 8401086 | Miami | Florida | |
| Medical Research Center of Miami II- Site Number : 8401019 | Miami | Florida | |
| Acevedo Clinical Research Associates- Site Number : 8401088 | Miami | Florida | |
| Future Care Solution - Miami- Site Number : 8401144 | Miami | Florida | |
| Sanchez Clinical Research- Site Number : 8401095 | Miami | Florida | |
| Florida International Research Center- Site Number : 8401091 | Miami | Florida | |
| Savin Medical Group - Miami Lakes- Site Number : 8401085 | Miami Lakes | Florida | |
| Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8401109 | Miami Lakes | Florida |
+ 350 more sites — see the full list on the official registry below.
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 NCT05492578 on ClinicalTrials.gov ↗ ← All trials in the UK