A study to evaluate the treatment response and safety of two dose regimens of subcutaneous amlitelimab monotherapy compared with treatment withdrawal in participants aged 12 years and older with moderate-to-severe atopic dermatitis (ESTUARY)
- Conditions
- Dermatitis atopic
- Registration Number
- jRCT2061240027
- Lead Sponsor
- Sanofi K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 961
- Participants must be at least 12 years of age inclusive, at the time the informed consent form (ICF) is signed.
- Must have participated, received study treatment without permanent investigational medicinal product 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 atopic dermatitis (AD).
- Able and willing to comply with requested study visit and procedures.
- Body weight must be >=25 kg.
Participants are excluded from the study if any of the following criteria apply:
- Developed a medical condition that would preclude participation as described in 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 investigational medicinal product 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 investigational medicinal product 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.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method Proportion of participants who maintain clinical response at Week (W) 48 of ESTUARY W48 Maintenance of clinical response is defined as having validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 (clear) or 1 (almost clear) and/or 75% reduction in Eczema Area and Severity Index (EASI) compared to parent study baseline EASI (EASI-75).
The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
- Secondary Outcome Measures
Name Time Method