A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Prurigo Nodularis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 76
- 主要终点
- WI-NRS4 Response at Week 12
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
详细描述
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PN ≥ 3 months before screening.
- •≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area <20% BSA.
- •IGA-CPG-S score of ≥ 2 at screening and baseline.
- •Baseline PN-related WI-NRS score ≥
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Chronic pruritus due to a condition other than PN
- •Total estimated BSA treatment area (excluding the scalp) > 20%.
- •Neuropathic and psychogenic pruritus
- •Active atopic dermatitis lesions within 3 months of screening and baseline.
- •Uncontrolled thyroid function
- •Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
- •Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
- •Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
- •Pregnant or lactating, or considering pregnancy.
- •History of alcoholism or drug addiction within 1 year
- •Known allergy or reaction to any of the components of the study drug.
- •Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
- •Employees of the sponsor or investigator or otherwise dependents of them.
- •The following participants are excluded in France:
- •Vulnerable populations according to article L.1121-6 of the French Public Health Code.
- •Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
- •Individuals not affiliated with the social security system.
研究组 & 干预措施
Ruxolitinib 1.5% Cream
Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
干预措施: Ruxolitinib Cream (Drug)
Vehicle Cream
Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will enter the open label extension (OLE) period for up to 40 weeks.
干预措施: Vehicle Cream (Drug)
结局指标
主要结局
WI-NRS4 Response at Week 12
时间窗: Baseline; Week 12
WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders.
次要结局
- WI-NRS4 Response at Week 4(Baseline; Week 4)
- Percentage of Participants With Overall-Treatment Success at Week 12(Baseline; Week 12)
- Percentage of Participants With IGA-CPG-S-TS at Week 12(Baseline; Week 12)
- WI-NRS4 Response at Day 7(Baseline; Day 7)
- WI-NRS4 Response at Each Post-baseline Visit(Baseline; up to Week 52)
- DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit(Baseline; up to Week 12)
- OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit(Baseline; up to Week 52)
- Time to ≥2-point Improvement From Baseline in WI-NRS Score(Baseline; up to Week 52)
- Time to ≥4-point Improvement From Baseline in WI-NRS Score(Baseline; up to Week 52)
- DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline(Baseline; up to Week 12)
- OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline(Baseline; up to Week 52)
- DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit(Baseline; up to Week 12)
- OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit(Baseline; up to Week 52)
- Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit(Baseline; up to Week 52)
- Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit(Baseline; up to Week 52)
- DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit(Baseline; up to Week 12)
- OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit(Baseline; up to Week 52)
- DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit(Baseline; up to Week 12)
- OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit(Baseline; up to Week 52)
- DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit(Baseline; up to Week 12)
- OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit(Baseline; up to Week 52)
- DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit(Baseline; up to Week 12)
- OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit(Baseline; up to Week 52)
- DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to Week 12)
- DBVC Period: Number of Participants With Any ≥Grade 3 TEAE(up to Week 12)
- OLE Period: Number of Participants With Any TEAE(from beginning of Week 13 up to Week 56)
- OLE Period: Number of Participants With Any ≥Grade 3 TEAE(from beginning of Week 13 up to Week 56)