2024-514737-37-00招募中3 期
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and safety of dupilumab for the treatment of pruritus of Lichen Simplex Chronicus (LSC) in adults
Sanofi-Aventis Recherche & Developpement21 个研究点 分布在 8 个国家目标入组 77 人开始时间: 2025年2月4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
- 77
- 试验地点
- 21
- 主要终点
- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
研究概览
简要总结
To demonstrate the efficacy of dupilumab on pruritus of LSC in adult participants with moderate-to-severe LSC inadequately controlled by topical therapies
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
- 是
入选标准
- •Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.
- •Participants with moderate-to-severe LSC, as defined by Investigator’s Global Assessment (IGA) score ≥3 and one or more of the following: at least 1 single anogenital lesion; at least 2 lesions including 1 lesion of ≥3 cm in diameter; at least 1 severe lesion (IGA score = 4).
- •History of LSC for at least 6 months prior to the screening visit.
- •On the Worst-Itch Numerical Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst-itch of LSC score of ≥7 in the 7 days prior to Day
- •A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned randomization date, randomization can be postponed until this requirement is met, but without exceeding the 28-day maximum duration of the screening period
- •History of failing a 2-week course of medium-to-superpotent topical corticosteroid (TCS) +/- topical calcineurin inhibitor (TCI) for the treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable. Patients with documented systemic treatment for LSC (other than antihistamines) in the past 6 months are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with dupilumab after appropriate washout.
- •Appropriate contraceptive measures
排除标准
- •Participants diagnosed with active lesions of prurigo nodularis (broadly distributed nodules) or active lesions of atopic dermatitis (AD) within 6 months, contact dermatitis, psoriasis, cutaneous T-cell lymphoma (CTCL) (or suspected of CTCL), vulvar lichen planus, or vulvar lichen sclerosus
- •Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, lichen planus hypertrophicus.
- •Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the participant’s participation in the study.
- •Severe psychiatric disease that, in the Investigator’s judgement, would affect the study intervention evaluation.
- •Having received or planning to use any of the treatments within the timeframe as specified in the protocol
结局指标
主要结局
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24
次要结局
- Change in weekly average of daily WI-NRS from baseline to Week 24
- Change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24
- Change in ItchyQoL score from baseline to Week 24
- Change in DLQI total score from baseline to Week 24
- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12
- Incidence of treatment-emergent ADA against dupilumab
- Percentage of participants experiencing TEAEs or SAEs from baseline through Week 24
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (21)
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