NCT06687980已完成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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 138
- 试验地点
- 127
- 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
This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC.
Study details include:
The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply (at screening and baseline unless otherwise specified):
- •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 are excluded from the study if any of the following criteria apply (at screening and baseline unless otherwise specified):
- •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) XE "CTCL" \f Abbreviation \t "cutaneous T-cell lymphoma" (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.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo subcutaneous injection as per protocol
干预措施: Placebo (Drug)
Dupilumab
Experimental
Dupilumab subcutaneous injection as per protocol
干预措施: Dupilumab (Drug)
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
时间窗: Week 24
Worst-Itch numerical rating score (WI-NRS) is a patient report outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").
次要结局
- Absolute change in weekly average of daily WI-NRS from baseline to Week 24(Baseline to Week 24)
- Percentage change in weekly average of daily WI-NRS from baseline to Week 24(Baseline to Week 24)
- Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24(Baseline through Week 24)
- Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24(Baseline to Week 24)
- Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab(Baseline through Week 36)
- Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)(Baseline through Week 36)
- Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24(Baseline to Week 24)
- Absolute change in ItchyQoL score from baseline to Week 24(Baseline to Week 24)
- Absolute change in DLQI total score from baseline to Week 24(Baseline to Week 24)
- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12(Week 12)
- Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24(Week 12 and 24)
- Absolute change in weekly average of daily WI-NRS from baseline to Week 24(Baseline to Week 24)
- Percentage change in weekly average of daily WI-NRS from baseline to Week 24(Baseline to Week 24)
- Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24(Week 12 and 24)
- Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24(Baseline to Week 24)
- Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24(Baseline to Week 24)
- Absolute change in ItchyQoL score from baseline to Week 24(Baseline to Week 24)
- Absolute change in DLQI total score from baseline to Week 24(Baseline to Week 24)
- Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab(Baseline through Week 36)
- Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12(Week 12)
- Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24(Baseline through Week 24)
- Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)(Baseline through Week 36)
研究者
研究点 (127)
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