EICHORCondition: Dermatitis Atopic · Sponsor: Sanofi
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This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD). The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal. Study details include: The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD). The study duration will be up to 52 weeks for participants entering the LTS17367 \[RIVER-AD\] study at the Week 52 visit of EFC17600 (ESTUARY).
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Participants must be at least 12 years of age inclusive, at the time the informed consent is signed. * Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate-to-severe AD. * Able and willing to comply with requested study visit and procedures. * Body weight must be ≥ 25 kg. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Developed a medical condition that would preclude participation as described in Exclusion Criteria or Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols. * Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE). * Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant. * Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study. * Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.). * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Cahaba Dermatology & Skin Health Center- Site Number : 8401066 | Birmingham, Alabama, United States | — |
| Center for Dermatology and Plastic Surgery- Site Number : 8401119 | Scottsdale, Arizona, United States | — |
| Scottsdale Clinical Trials- Site Number : 8401149 | Scottsdale, Arizona, United States | — |
| Eclipse Clinical Research- Site Number : 8401158 | Tucson, Arizona, United States | — |
| Johnson Dermatology- Site Number : 8401076 | Fort Smith, Arkansas, United States | — |
| Encino Research Center- Site Number : 8401042 | Encino, California, United States | — |
| First OC Dermatology- Site Number : 8401025 | Fountain Valley, California, United States | — |
| Center for Dermatology Clinical Research- Site Number : 8401018 | Fremont, California, United States | — |
| Marvel Clinical Research- Site Number : 8401102 | Huntington Beach, California, United States | — |
| Sunwise Clinical Research- Site Number : 8401022 | Lafayette, California, United States | — |
| Torrance Clinical Research - Narbonne Avenue- Site Number : 8401027 | Lomita, California, United States | — |
| Dermatology Research Associates - Los Angeles- Site Number : 8401092 | Los Angeles, California, United States | — |
+ 312 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06407934