A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo
- Conditions
- NonSegmental Vitiligo
- Interventions
- Drug: Vehicle Cream
- Registration Number
- NCT06548360
- Lead Sponsor
- Incyte Corporation
- Brief Summary
The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- Clinical diagnosis of nonsegmental vitiligo with depigmented area including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 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.
- 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.
- Current or previous use of JAK inhibitors, systemic or topical.
- Protocol-defined clinically significant abnormal laboratory values at screening.
- BMI-for-age < 5th percentile or ≥ 85th percentile according to the CDC BMI Percentile Calculator for Child and Teen.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ruxolitinib 1.5 % Cream Ruxolitinib Cream Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Vehicle Cream Vehicle Cream Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) Week 24 ≥75% improvement in facial Vitiligo Area Scoring Index.
- Secondary Outcome Measures
Name Time Method Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) Week 52 ≥50% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) Week 52 ≥90% improvement in facial Vitiligo Area Scoring Index.
Percentage change from baseline in F-BSA Week 24 Facial body surface area (F-BSA) takes into account the facial depigmented areas as a percentage of the total body area.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) Week 24 and Week 52 ≥90% improvement in total body Vitiligo Area Scoring Index
Pharmacokinetic (PK) of Ruxolitinib: Trough concentrations Weeks 6, 24, 30 and 52 Trough is defined as the concentration reached by a drug immediately before the next dose is administered.
Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) Week 24 ≥50% improvement in total body Vitiligo Area Scoring Index.
Number of Treatment Emergent Adverse Events (TEAEs) Up to Week 52 and 30 days TEAE defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25) Week 24 and Week 52 ≥25% improvement in total body Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) Week 24 and Week 52 ≥75% improvement in total body Vitiligo Area Scoring Index
Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) Week 52 ≥75% improvement in facial Vitiligo Area Scoring Index.
Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) Week 52 ≥50% improvement in total body Vitiligo Area Scoring Index.
Related Research Topics
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Trial Locations
- Locations (91)
Skin Care Research, Llc
🇺🇸Hollywood, Florida, United States
Encore Medical Research, Llc Boynton Beach
🇺🇸Boynton Beach, Florida, United States
Pediatric Skin Research Llc
🇺🇸Coral Gables, Florida, United States
Solutions Through Advanced Research, Inc
🇺🇸Jacksonville, Florida, United States
Nicklaus Children'S Hospital
🇺🇸Miami, Florida, United States
Dh Tamarac Research Center Etna Medical Center Emc
🇺🇸Tamarac, Florida, United States
Usf Health Morsani Center For Advanced Healthcare
🇺🇸Tampa, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Cleaver Medical Group
🇺🇸Cumming, Georgia, United States
Advanced Medical Research Pc
🇺🇸Sandy Springs, Georgia, United States
Scroll for more (81 remaining)Skin Care Research, Llc🇺🇸Hollywood, Florida, United States