A Safety and Efficacy Study of Ruxolitinib Cream Combined With Narrow-Band Ultraviolet B Phototherapy in Participants With Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 13
- 主要终点
- Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream with or without phototherapy in adolescent and adult participants with non-segmental vitiligo for whom vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
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
- None
入排标准
- 年龄范围
- 12 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of nonsegmental vitiligo with depigmented area including all of the following:
- •≥ 0.5 F-VASI on the face
- •≥ 3.0 T-VASI (body areas not including the face)
- •Total body vitiligo area (facial and nonfacial) not exceeding 10% BSA.
- •Agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
排除标准
- •No pigmented hair within any of the vitiligo areas on the face.
- •Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or other skin depigmentation disorders.
- •Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
- •Previous adverse reaction to NB-UVB phototherapy that caused discontinuation of therapy.
- •Lack of response (little or no repigmentation) to prior NB-UVB phototherapy.
- •History of thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke, myocardial infarction).
- •Any other skin disease that, in the opinion of the investigator, would interfere with the study cream application or study assessments.
- •Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox) within 1 week before baseline.
- •Any serious illness or medical, physical, or psychiatric condition(s) that pose a significant risk to the participant; or interfere with interpretation of study data.
- •Recent use of topical or systemic medications (including biologics or JAK inhibitors), or laser or phototherapy to treat vitiligo. Note: Recent may be defined differently for different treatments.
- •Specific protocol-defined chemistry, hematology, and serological lab values.
- •Those who are pregnant, lactating or considering pregnancy during the period of study participation.
研究组 & 干预措施
Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have < 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.
干预措施: Ruxolitinib 1.5% cream (Drug)
Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)
Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have < 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.
干预措施: NB-UVB phototherapy (Device)
Group B: Ruxolitinib Monotherapy
Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.
干预措施: Ruxolitinib 1.5% cream (Drug)
结局指标
主要结局
Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48
时间窗: Baseline; Week 48
T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area \[BSA\] estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).
次要结局
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to approximately 52 weeks)
- Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Score at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI75) Score at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI90) Score at Each Post-Baseline Visit(Baseline; up to Week 48)
- Change From Baseline in F-VASI at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit(Baseline; up to Week 48)
- Change From Baseline in T-VASI at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit(Baseline; up to Week 48)
- Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit(Baseline; up to Week 48)
- Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit(Baseline; up to Week 48)
- Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit(Baseline; up to Week 48)
- Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16(pre-application at Weeks 4, 12, and 16)