NCT06959225进行中（未招募）3 期
A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 580
- 试验地点
- 203
- 主要终点
- Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of HS for at least 6 months prior to screening visit.
- •Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:
- •A total AN count of at least 4, with no draining tunnels AND
- •Affecting at least 2 distinct anatomical areas
- •Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
- •Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period.
- •Further inclusion criteria apply.
排除标准
- •Body surface areas to be treated exceed 20% BSA at screening or baseline
- •Presence of draining tunnels at screening or baseline.
- •Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •Laboratory values outside of the protocol-defined criteria.
- •Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
- •Further exclusion criteria apply.
研究组 & 干预措施
Vehicle Cream
Placebo Comparator
Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
干预措施: Vehicle Cream (Drug)
Ruxolitinib 1.5 % Cream
Experimental
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
干预措施: Ruxolitinib Cream (Drug)
结局指标
主要结局
Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
时间窗: Week 16
HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and/or inflammatory nodule (AN) count with no increase from baseline in abscess or draining tunnel count.
次要结局
- Percentage change from baseline in total AN count at each postbaseline visit(Up to 52 weeks)
- Mean change from baseline in total AN count at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Proportion of participants with ≥ 1 HS flare(Up to 16 weeks)
- Proportion of participants who achieve HiSCR50/75/90/100 at each postbaseline visit(Up to 16 weeks)
- Extension Period: Proportion of participants with ≥ 1 HS flare(From Week 16 through Week 52)
- Proportion of participants who achieve abscess and/or inflammatory nodule (AN)75 at each postbaseline visit(Up to 52 weeks)
- Proportion of participants with ≥ 1 flare(Up to 16 weeks)
- Proportion of participants who achieve HiSCR50(Week 16)
- Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3(Week 16)
- Treatment-IR Population: Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3(Week 16)
- Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3 at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline(Week 16)
- Mean change from baseline in abscess count at each postbaseline visit(Up to 52 weeks)
- Percentage change from baseline in abscess count at each postbaseline visit(Up to 52 weeks)
- Mean change from baseline in inflammatory nodule count at each postbaseline visit(Up to 52 weeks)
- Percentage change from baseline in inflammatory nodule count at each postbaseline visit(Up to 52 weeks)
- Proportion of participants with presence of draining tunnels at each postbaseline visit(Up to 52 weeks)
- Proportion of participants who achieve Itch Numeric Rating Scale (NRS)30 among participants with baseline Itch NRS score ≥ 3 at each postbaseline visit(Up to 52 weeks)
- Proportion of participants who achieve Patient Global Impression of Change (PGIC) at each postbaseline visit(Up to 52 weeks)
- Proportion of participants who achieve PGIC score 1 or 2 at each postbaseline visit(Up to 52 weeks)
- Patient Global Impression of Severity (PGIS) score at each postbaseline visit(Up to 52 weeks)
- Change from baseline in PGIS Score at each postbaseline visit(Up to 52 weeks)
- Proportion of participants who achieve status of Dermatology Life Quality Index (DLQ1)4 at each postbaseline visit(Up to 52 weeks)
- Proportion of participants who achieve status of Children's Dermatology Life Quality Index (CDLQ1)6 at each postbaseline visit(Up to 52 weeks)
- Change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit(Up to 52 weeks)
- Percent change from baseline in Hidradenitis Suppurativa Quality of Life (HiSQoL) score at each postbaseline visit(Up to 52 weeks)
- Change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit(Up to 52 weeks)
- Percent change from baseline in Hidradenitis Suppurativa Quality of Life - Adolescent (HiSQoL-AA) at each postbaseline visit(Up to 52 weeks)
- Change from baseline in EuroQol 5-dimension 5-level scale (EQ-5D-5L) score at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Change from baseline in total abscess count at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Percent change from baseline in total abscess count at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Change from baseline in total inflammatory nodule count at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Percent change from baseline in total inflammatory nodule count at each postbaseline visit(Up to 52 weeks)
- Treatment-IR Population: Proportion of participants with presence of draining tunnels at each postbaseline visit(Up to 52 weeks)
- Number of Treatment Emergent Adverse Events (TEAEs)(Up to 56 weeks)
研究者
研究点 (203)
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