A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Official title

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Overview

The purpose of this study is to to evaluate the safety and efficacy of ruxolitinib cream in pediatric participants with nonsegmental vitiligo.

Interventions

• Drug Ruxolitinib Cream
  Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
• Drug Vehicle Cream
  Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Primary outcome measures

• Proportion of Participants Achieving a ≥ 75% Improvement From Baseline in the Facial Vitiligo Area Scoring Index (F-VASI75) [Time frame: Week 24]

Secondary outcome measures (12)

• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) [Time frame: Week 24]
• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) [Time frame: Week 24]
• Proportion of Participants Achieving a ≥ 50% Improvement From Baseline in the Total Body Vitiligo Area Scoring Index (T-VASI50) [Time frame: Week 24]
• Percentage change from baseline in F-BSA [Time frame: Week 24]
• Number of Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to Week 52 and 30 days]
• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI50) [Time frame: Week 52]
• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI75) [Time frame: Week 52]
• Proportion of Participants Achieving Facial Vitiligo Area Scoring Index (F-VASI90) [Time frame: Week 52]
• Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI50) [Time frame: Week 52]
• Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI25) [Time frame: Week 24 and Week 52]
• Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI75) [Time frame: Week 24 and Week 52]
• Proportion of Participants Achieving Total Body Vitiligo Area Scoring Index (T-VASI90) [Time frame: Week 24 and Week 52]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 79 centers

• University of Alabama At Birmingham-School of Medicine — Birmingham
• Saguaro Dermatology — Phoenix
• Phoenix Children'S Hospital — Phoenix
• Omni Dermatology — Phoenix
• Affiliated Dermatology — Scottsdale
• Banner - University Medicine Multispecialty Services Clinic — Tucson
• Premier Dermatology Clinical Trials Institute At Northwest Arkansas — Fayetteville
• Burke Pharmaceutical Research — Hot Springs
• … and 71 more centers

Canada · 19 centers

• Kirk Barber Research — Calgary
• … and 18 more centers

Identifiers

NCT: NCT06548360 · INCB18424-312

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗