A long-term extension study to evaluate the long-term safety, tolerability and efficacy of subcutaneous amlitelimab in adult participants with moderate to severe atopic dermatitis who participated in KY1005-CT05 (DRI17366).

Sanofi-aventis recherche & développement0 个研究点目标入组 315 人开始时间: 2022年7月11日最近更新: 2022年8月8日

试验速览

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•- Participant must be 18 years of age, inclusive, or older at the time of signing the informed consent.
•- Participated in KY1005-CT05 (DRI17366) for moderate to severe AD and received study treatment, adequately completed the assessments required for the treatment period, is still receiving investigational medicinal product (IMP) at the defined end of study for that participant and is from one of the following 3 cohorts:
•-- Cohort 1 - participants at Week 24 in the KY1005-CT05 (DRI17336) study who have not achieved an = Eczema Area and Skin Severity Index (EASI)-75 and/or Investigator Global Assessment (IGA) 0/1
•-- Cohort 2 - participants at or after Week 28 and before Week 52 who lose clinical response. Loss of clinical response is defined as the first instance of < EASI-50 during the second study period
•-- Cohort 3 - participants at Week 24 in KY1005-CT05 (DRI17336) who have been re-randomized and who subsequently complete the study to Week 52, enter safety follow-up and experience worsening of their AD during safety follow-up or thereafter
•- Provide signed informed consent and able to comply with the requirements of the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Participants are excluded from the study if any of the following criteria apply:
•- Any participant who has received prohibited systemic therapies, as per KY1005-CT05 (DRI17366) clinical trial protocol, either during or after completion of KY1005-CT05 (DRI17366) participation will not be eligible for the ong-term extension (LTE)
•- Participants who, during their participation in KY1005-CT05 (DRI17366), developed an adverse events (AE) or a serious adverse event (SAE) deemed related to amlitelimab, which in the opinion of the Investigator or of the Medical Monitor could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant
•- Conditions in KY1005-CT05 (DRI17366), consistent with protocol-defined criteria for permanent IMP discontinuation, if deemed related to amlitelimab or led to Investigator or Sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.).
•- Developed a medical condition that would preclude participation as per KY1005-CT05 (DRI17366) clinical trial protocol
•- Concurrent participation in any other clinical study, including non-interventional studies

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