2024-511225-64-00已完成2 期
A Phase 2, randomized, double-blind, placebo-controlled, parallel group, 3-arm, multinational, multicenter, proof-of-concept study to evaluate the efficacy and safety of amlitelimab monotherapy by subcutaneous injection in adult participants with severe alopecia areata
Sanofi-Aventis Recherche & Developpement29 个研究点 分布在 8 个国家目标入组 74 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 29
- 主要终点
- Change from baseline in SALT score at Week 36
研究概览
简要总结
To evaluate the efficacy of amlitelimab compared to placebo in adult participants with AA with 50% or greater scalp hair loss on regrowth of lost hair
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Definitive diagnosis of AA of more than 6 months.
- •Diagnosis of severe AA, as determined by all of the following: a) Hair loss affecting ≥50% of the scalp, as measured by Severity of Alopecia Tool (SALT) at both screening and baseline visits. b) Current episode of severe hair loss of less than 8 years. Participants with a history of AA of more than 8 years who have observed episodes of terminal hair regrowth over their scalp (“moving patches” spontaneously or following treatment) in the past 8 years can be included. c) Stable disease: no evidence of terminal hair regrowth within 6 months (ie, equivalent to less than 10% improvement points spontaneous reduction in SALT over the past 6 months). (guidance: if participant reports to have quite a bit more hair than 6 months prior, then patient cannot be included).
- •Willingness in maintaining a consistent hair style and hair care, including hair products, and to refrain from weaves, extensions, adhesive wigs, other than banded perimeter devices, refrain from shaving of scalp hair for 2 weeks prior to each study visit from baseline to the EOS.
排除标准
- •Participants that are currently experiencing other forms of alopecia, including but not limited to: androgenetic alopecia, trichotillomania, telogen effluvium, traction alopecia, scarring alopecia.
- •Participants currently with any local or systemic active medical conditions which in the opinion of the Investigator would interfere with evaluations of the IMP effect on AA due to scalp inflammation, including but not limited to seborrheic dermatitis requiring topical treatment to the scalp, lupus erythematosus, lichen planus, psoriasis, secondary syphilis, tinea capitis, thyroiditis, systemic sclerosis, hair transplants, micropigmentation/tattoo of the scalp
- •Received the specified treatment regimens within the timeframe outlined in the protocol.
- •Prior use of any oral JAKi or the topical JAKi ruxolitinib for more than 24 months, regardless if washout period is respected.
- •Subjects with shaved heads must not enter the study until hair has grown back and SALT score can be reliably administered.
研究组 & 干预措施
Amlitelimab
Test
干预措施: Amlitelimab (Drug)
Amlitelimab matching placebo to test product
Placebo
干预措施: Amlitelimab matching placebo to test product (Drug)
结局指标
主要结局
Change from baseline in SALT score at Week 36
Change from baseline in SALT score at Week 36
次要结局
- Change from the baseline in SALT score at Week 24 (key secondary)
- Proportion of participants achieving a SALT score ≤20 at Weeks 24 and 36
- Time to SALT score ≤20
- Proportion of participants achieving a SALT score ≤10 at Weeks 24 and 36
- Time to SALT score ≤10
- Proportion of participants achieving a SALT50 at Weeks 24 and 36
- Proportion of participants achieving a SALT75 at Weeks 24 and 36
- Proportion of participants achieving a SALT90 at Weeks 24 and 36
- Proportion of participants achieving ClinRO Measure for eyebrow (EB) Hair Loss 0 or 1 with ≥2-point improvement from baseline at Weeks 24 and 36 (among participants with ClinRO Measure for EB Hair Loss ≥2 at Baseline)
- Proportion of participants achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 with ≥2-point improvement from baseline (among participants with ClinRO Measure for EL Hair Loss ≥2 at Baseline)
- Proportion of participants achieving a PGI-C response defined as a score of “moderately improved” or “greatly improved” at Weeks 24 and 36
- Proportion of participants achieving a PGI-S response defined as a score of “mild“ or “none” at Weeks 24 and 36
- Mean changes from baseline in SKINDEX-16AA at Weeks 24 and 36
- Proportion of participants with PRO Scalp Hair Assessment score of 0 to 1 with ≥2-point improvement from baseline (among participants with PRO Scalp Hair Assessment score ≥3 at Baseline)
- Proportion of participants achieving grade 0 or 1 with ≥2point improvement from baseline PRO Measure for EB Hair Loss (among participants with PRO Measure for EB Hair Loss ≥2 at Baseline)
- Proportion of participants achieving grade 0 or 1 with ≥2point improvement from baseline PRO Measure for EL Hair Loss at Weeks 24 and 36 (among participants with PRO Measure for EL Hair Loss ≥2 at Baseline)
- Proportion of participants who experienced treatment-emergent adverse events (TEAEs), experienced treatment-emergent serious adverse event (TESAEs) and/or Treatment-Emergent adverse event of special interest (AESIs)
- Serum amlitelimab concentrations measured at prespecified timepoints
- Incidence of ADAs) of amlitelimab at prespecified timepoints
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (29)
Loading locations...
相似试验
已完成
2 期
Dose ranging study of amlitelimab in adult participants with moderate-to-severe asthmaAsthma2024-510641-33-00Sanofi-Aventis Recherche & Developpement104
招募中
2 期
Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric CancerAdebrelimabAdenocarcinoma of GE JunctionAdenocarcinoma of StomachNCT07353684Beijing Friendship Hospital49
撤回
2 期
Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS TrialHematopoietic and Lymphatic System NeoplasmNCT07349771Mayo Clinic72
招募中
1 期
Atamparib in Patients With Advanced Solid TumorsNCT07374419Nerviano Medical Sciences (Shanghai) Ltd.178
招募中
3 期
A Study to Evaluate the Efficacy and Safety of 608 in Adult Subjects With Active Ankylosing Spondylitis(AS)Ankylosing SpondylitisNCT07261644Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.500