A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 19
- 主要终点
- Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
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. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.
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
- •Diagnosis of HS based on clinical history and physical examination for at least 3 months.
- •Diagnosis of HS (Hurley I or II) with the following:
- •A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND
- •The AN count at the screening AND baseline visits:
- •AN of 3 should affect at least 1 distinct anatomical area
- •AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas.
- •Baseline Skin Pain or Itch NRS score ≥
- •Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.
- •Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
- •Willingness to avoid pregnancy or fathering children
排除标准
- •Presence of draining tunnels at screening or at baseline visits.
- •Concurrent conditions and history of other diseases:
- •Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS.
- •Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety.
- •Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
- •Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
- •Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline.
- •Laboratory values outside of the protocol-defined criteria.
- •Use of any prohibited medications per protocol-defined criteria.
- •Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
- •Other exclusion criteria may apply.
研究组 & 干预措施
Ruxolitinib Cream
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
干预措施: Ruxolitinib cream (Drug)
Vehicle Cream
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
时间窗: Baseline; Week 16
The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
次要结局
- Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16(Baseline; Week 16)
- Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline(Baseline; Week 16)
- Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16(Baseline; Week 16)
- Change From Baseline in Itch NRS Score at Week 16(Baseline; Week 16)
- Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16(Baseline; Week 16)
- Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16(Baseline; Week 16)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period(up to Week 16 plus 30 days)
- Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period(up to Week 16 plus 30 days)
- Number of Participants With Any TEAE in the Open-label Extension (OLE) Period(from Week 17 up to Week 32 plus 30 days)
- Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period(from Week 17 up to Week 32 plus 30 days)