A Randomized, Double-Blind, Dose-Ranging Study of INCB018424 Phosphate Cream in Subjects With Vitiligo
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 157
- 试验地点
- 26
- 主要终点
- Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24
研究概览
简要总结
The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of vitiligo.
- •Vitiligo with depigmented areas including:
- •at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm [without digits]) AND
- •at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints [palm plus 5 digits]).
- •Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.
排除标准
- •Conditions at baseline that would interfere with evaluation of vitiligo.
- •Participants who are receiving any kind of phototherapy, including tanning beds.
- •Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
- •Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
- •Participants who have received any of the following treatments within the minimum specified timeframes.
- •Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
- •Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
- •Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
- •Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
- •Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
- •Participants with protocol-defined cytopenias at screening
- •Participants with severely impaired liver function.
- •Participants with impaired renal function.
- •Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
- •Participants who have previously received JAK inhibitor therapy, systemic or topical.
研究组 & 干预措施
Ruxolitinib cream 1.5% twice daily (BID)
Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Ruxolitinib cream (Drug)
Ruxolitinib cream 1.5% once daily (QD)
Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Ruxolitinib cream (Drug)
Ruxolitinib cream 1.5% once daily (QD)
Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Vehicle cream (Drug)
Ruxolitinib cream 0.5% QD
Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Ruxolitinib cream (Drug)
Ruxolitinib cream 0.5% QD
Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Vehicle cream (Drug)
Ruxolitinib cream 0.15% QD
Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if < 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Ruxolitinib cream (Drug)
Ruxolitinib cream 0.15% QD
Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if < 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Vehicle cream (Drug)
Vehicle BID
Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Ruxolitinib cream (Drug)
Vehicle BID
Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24
时间窗: Baseline; Week 24
An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).
次要结局
- Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52(up to 52 weeks)
- Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear(Week 24)
- Dose Response on Percentage Change From Baseline in F-VASI(up to 156 weeks)
- Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 24 to Week 52(Week 24 to Week 52)
- Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24(up to 24 weeks)
- Percentage of Participants Who Achieved an F-VASI50 at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Mean Change From Baseline in T-VASI Score at Week 24(Baseline; Week 24)
- Number of Participants Who Applied Ruxolitinib 1.5% Cream BID Throughout Study Participation With Any TEAE and Any Grade 3 or Higher TEAE(up to Week 156)
- Percentage Change From Baseline in T-BSA Repigmentation at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Percentage Change From Baseline in T-VASI Score at Week 24(Baseline; Week 24)
- Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area(Baseline; Weeks 52 and 104)
- Mean Change From Baseline in VETF Scale Scores at Week 24: Total Staging(Baseline; Week 24)
- Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52(Baseline; Week 52)
- Mean Change From Baseline in F-VASI Score at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Percentage Change From Baseline in F-VASI Score at Week 24(Baseline; Week 24)
- Percentage Change From Baseline in F-BSA Repigmentation at Week 24(Baseline; Week 24)
- Mean Change From Baseline in Vitiligo European Task Force (VETF) Scale Scores at Week 24: Total Spreading(Baseline; Week 24)
- Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE From Week 52 to Week 156(Week 52 to Week 156)
- Percentage Change From Baseline in T-BSA Repigmentation at Week 24(Baseline; Week 24)
- Mean Change From Baseline in T-VASI Score at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging(Baseline; Weeks 52 and 104)
- Percentage of Participants in Each Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) Category at Week 24(Week 24)
- Mean Change From Baseline in F-VASI Score at Week 24(Baseline; Week 24)
- Percentage Change From Baseline in F-VASI Score at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Percentage Change From Baseline in F-BSA Repigmentation at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Percentage Change From Baseline in T-VASI Score at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Spreading(Baseline; Weeks 52 and 104)
- Mean Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area(Baseline; Week 24)
- Percentage Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Staging(Baseline; Weeks 52 and 104)
- Percentage of Participants in Each Patient Global Impression of Change for Vitiligo (PaGIC-V) Category at Week 24(Baseline; Week 24)
- Percentage of Participants in Each PaGIC-V Category at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Time to Achieve an T-PhGVA of Clear or Almost Clear(up to 52 weeks)
- Mean Change From Baseline in VETF Scale Scores at Weeks 52 and 104: Total Percentage Area(Baseline; Weeks 52 and 104)
- Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Percentage Area(Baseline; Week 24)
- Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Week 24(Week 24)
- Percentage of Participants in Each Facial Assessment of the PaGVA (F-PaGVA) Category at Weeks 52, 104, and 156(Weeks 52, 104, and 156)
- Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Weeks 52, 104, and 156(Baseline; Weeks 52, 104, and 156)
- Time to Achieve an F-PhGVA of Clear or Almost Clear(up to 52 weeks)
- Percentage Change From Baseline in VETF Scale Scores at Week 24: Total Staging(Baseline; Week 24)
- Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Week 24(Week 24)
- Time to Achieve a T-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the T-VASI50 Score(up to 52 weeks)
- Percentage of Participants in Each Facial Assessment of the PhGVA (F-PhGVA) Category at Weeks 52, 104 and 156(Weeks 52, 104, and 156)
- Percentage of Participants in Each Total Body Assessment of the PhGVA (T-PhGVA) Category at Weeks 52, 104 and 156(Weeks 52, 104, and 156)
- Percentage of Participants in Each Total Body Assessment of the PaGVA (T-PaGVA) Category at Weeks 52, 104, and 156(Weeks 52, 104, and 156)
- Percentage of Participants Who Report a PaGIC-V Score of Very Much Improved or Much Improved at Week 24(Baseline; Week 24)
- Percentage of Participants in Each Facial Assessment of the Patient's Global Vitiligo Assessment (F-PaGVA) Category at Week 24(Week 24)
- Time to Achieve an F-VASI50: Number of Days From the Date of the First Application in the Double-Blind Period to the Date of the First Evaluation at Which the Participant Met the F-VASI50 Score(up to 52 weeks)
- Time to Achieve a PaGIC-V of Very Much Improved or Much Improved(up to 52 weeks)