Clinical Trials List
2024-05-31 - 2027-05-31
Phase III
Recruiting5
ICD-10L20.0
Besnier's prurigo
ICD-10L20.81
Atopic neurodermatitis
ICD-10L20.82
Flexural eczema
ICD-10L20.83
Infantile (acute) (chronic) eczema
ICD-10L20.84
Intrinsic (allergic) eczema
ICD-10L20.89
Other atopic dermatitis
ICD-10L20.9
Atopic dermatitis, unspecified
ICD-9691.8
Other atopic dermatitis and related conditions
A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 52-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis
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Trial Applicant
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Sponsor
Sanofi Taiwan Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 卓雍哲 Division of Dermatology
- Chih-Chieh Chan Division of Dermatology
- 陳柏樺 Division of Dermatology
- WEI-HSIN WU Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鄭裕文 無
- Lai San Wong 無
- 曾涵琪 無
- 林尚宏 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Cheng-Yuan Li 無
- DINGDAR LEE 無
- 吳貞宜 無
- 張綜顯 無
- 何翊芯 無
- Yun-Ting Chang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
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.
Inclution 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.
The Estimated Number of Participants
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Taiwan
18 participants
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Global
1500 participants
