NCT06548360招募中3 期
A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 193
- 主要终点
- Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
研究概览
简要总结
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 2% BSA on nonfacial areas, ≥ 2 T-VASI.
- •Total body vitiligo area does not exceed 10% BSA.
- •Pigmented hair within some of the areas of vitiligo on the face.
- •Must agree to discontinue all agents used to treat vitiligo from screening through the final safety follow-up visit.
- •For sexually active participants (except participants who are prepubescent) willingness to avoid pregnancy or fathering a child from screening through 30 days after the last application of study cream.
排除标准
- •Diagnosis of other forms of vitiligo (eg, segmental).
- •Other differential diagnosis of vitiligo or other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- •Any other skin disease that, in the opinion of the investigator, would interfere with the study drug application or study assessments.
- •Prior or current use of depigmentation treatments (eg, monobenzone).
- •Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including application of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
- •Use of protocol-defined treatments within the indicated washout period before baseline.
- •History of treatment failure with any systemic or topical JAK inhibitor (eg, ruxolitinib, tofacitinib, baricitinib, abrocitinib, and upadacitinib) for vitiligo or any other inflammatory condition.
- •Protocol-defined clinically significant abnormal laboratory values at screening.
- •Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
- •In the opinion of the investigator, unable or unlikely to comply with the application schedule and study evaluations.
- •Living with anyone participating in any current Incyte-sponsored ruxolitinib cream study.
- •Employees of the sponsor or investigator or are otherwise dependents of them.
- •Known allergy or reaction to any component of the study cream formulation.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
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)
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)
结局指标
主要结局
Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75)
时间窗: Week 24
≥75% improvement in facial Vitiligo Area Scoring Index.
次要结局
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)(Week 52)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)(Week 52)
- Percentage change from baseline in F-BSA(Week 24)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90)(Week 24 and Week 52)
- Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations(Weeks 6, 24, 30 and 52)
- Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50)(Week 24)
- Number of Treatment Emergent Adverse Events (TEAEs)(Up to Week 52 and 30 days)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25)(Week 24 and Week 52)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75)(Week 24 and Week 52)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75)(Week 52)
- Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50)(Week 52)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50)(Week 24)
- Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90)(Week 24)
研究者
研究点 (193)
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