CTRI/2025/01/078988招募中3 期
A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 48-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered as monotherapy by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis
Sanofi Healthcare India Pvt Limited7 个研究点 分布在 1 个国家目标入组 961 人开始时间: 2025年1月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 961
- 试验地点
- 7
- 主要终点
- To demonstrate the maintenance of treatment response to amlitelimab monotherapy Q4W compared to treatment withdrawal and subsequently amlitelimab monotherapy Q12W compared to treatment withdrawal in responders with moderate-to-severe AD
研究概览
简要总结
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 AD.
The main objective of this study is to evaluate if those participants who received amlitelimab Q4W in the parent studies (EFC17559 [COAST-1], EFC17560 [COAST 2], EFC17561 [SHORE]) and were responders can maintain their treatment response either remaining at Q4W frequency or switching to a Q12W regimen of amlitelimab compared to treatment withdrawal (Group A).
Study details include:
• The study duration will be up to 64 weeks (for participants not entering the LTS17367 [RIVER-AD] study) including a 48-week randomized double-blind period, and a 16-week safety follow-up.
• The study duration will be up to 48 weeks for participants entering the LTS17367[RIVER-AD] study at the Week 48 visit of EFC17600 (ESTUARY).
• The total treatment duration will be up to 48 weeks.
• The total number of visits will be up to 14 visits (or 13 visits for those entering LTS17367 [RIVER-AD] study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must be at least 12 years of age inclusive, at the time the informed consent is signed. I
- •Must have participated, received study treatment without permanent 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.
- •Must have complied with the clinical trial protocol in EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE) to the satisfaction of the Investigator. I03 Able and willing to comply with requested study visit and procedures. I04 Body weight must be ≥ 25 kg I05 All participants Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a-Male participants Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 5 months after the last administration of study intervention- o Refrain from donating sperm Plus either-.
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR o Must agree to use contraception/barrier as detailed below:.
- •A male condom: the participant should also be advised of the benefit for a female partner to use a highly effective method of contraception (as will be described in Section 10.4) as a condom may break or leak when having sexual intercourse with a WOCBP who is not currently pregnant Female Participants A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies.
- •Is a woman of nonchildbearing potential (WONCBP). OR.
- •Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of less than 1percent, as will be described in section 10.4, during the study intervention period (to be effective before starting the intervention) and for at least 5 months after the last administration of study intervention. • A WOCBP must have a negative highly sensitive pregnancy test (serum as required by local regulations) within 30 days before the first administration of study intervention, as will be described in Section 8.3.
- •Capable of giving a signed informed assent and/or consent as described in Appendix 1 (Section 10.1) of the protocol which includes the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. The signed ICF must always be present at the time of inclusion.
排除标准
- •Participants are excluded from the study if any of the following criteria apply. E 01 Developed a medical condition that would preclude participation as described in Section 5.2 (Exclusion Criteria) or Section 7.1.1 (Permanent Discontinuation) of EFC17559 (COAST-1)/EFC17560 (COAST-2)/EFC17561 (SHORE) clinical trial protocols. E02 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). E03 Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an AE or a 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. E04 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. E05 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.). E6 In the Investigators opinion any significant abnormality on 12-lead ECG at the baseline visit that could be suggestive of an unstable or underlying cardiovascular condition that could preclude the participant’s participation in the study. E7 Individuals accommodated in an institution because of regulatory or legal order; participants who are legally institutionalized, persons who have been placed in an institution based on an official court order. E8 Any country-related specific regulation that would prevent the participant from entering the study. E9 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. E10 Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals E11 Participants dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6). E12Any anticipated situation during study implementation/course that may raise ethics considerations.
结局指标
主要结局
To demonstrate the maintenance of treatment response to amlitelimab monotherapy Q4W compared to treatment withdrawal and subsequently amlitelimab monotherapy Q12W compared to treatment withdrawal in responders with moderate-to-severe AD
时间窗: Baseline, Week 48
次要结局
- To demonstrate the maintenance of treatment response to amlitelimab monotherapy compared to treatment withdrawal in responders with moderate -to-severe AD(Baseline, Week 48)
- To characterize the treatment response to amlitelimab monotherapy in non-responders with moderate-to-severe AD(Baseline, Week 48)
研究者
研究点 (7)
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