Condition: Dermatitis Atopic · Sponsor: Sanofi
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).
This description comes directly from the study's public registry record.
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| University of Alabama at Birmingham- Site Number : 8401267 | Birmingham, Alabama, United States | Recruiting |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale, Arizona, United States | Recruiting |
| Arkansas Dermatology - North Little Rock- Site Number : 8401244 | North Little Rock, Arkansas, United States | Recruiting |
| Encino Research Center- Site Number : 8401042 | Encino, California, United States | Recruiting |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont, California, United States | Recruiting |
| Long Beach Clinical Trials- Site Number : 8401188 | Long Beach, California, United States | Recruiting |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles, California, United States | Recruiting |
| LA Universal Research Center- Site Number : 8401064 | Los Angeles, California, United States | Recruiting |
| University Dermatology Trials- Site Number : 8401339 | Newport Beach, California, United States | Recruiting |
| Rady Children's Hospital- Site Number : 8401291 | San Diego, California, United States | Recruiting |
| Therapeutics Clinical Research- Site Number : 8401283 | San Diego, California, United States | Recruiting |
| Paradigm Clinical Research - Wheat Ridge- Site Number : 8401245 | Wheat Ridge, Colorado, United States | Recruiting |
+ 138 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06241118