Phase 2
N=55
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream With Phototherapy in Participants With Vitiligo
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT05247489 ↗Enrolled (actual)
55
Serious AEs
3.6%
Results posted
Feb 2025
Primary outcome: Primary: Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 — 6.58; 6.87; -3.43; -3.46 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib 1.5% cream (Drug); NB-UVB phototherapy (Device)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48 |
6.58; 6.87; -3.43; -3.46 | — |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (TEAE) |
9; 21 | — |
| SECONDARY Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit |
6.3; 5.7; 21.4; 17.1; 63.6; 31.4 | — |
| SECONDARY Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit |
6.3; 0.0; 7.1; 0.0; 45.5; 14.3 | — |
| SECONDARY Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit |
0.0; 0.0; 0.0; 0.0; 9.1; 0.0 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.0; 18.2; 0.0 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY 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 |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Change From Baseline in F-VASI at Each Post-Baseline Visit |
1.00; 0.91; -0.13; -0.05; -0.26; -0.14 | — |
| SECONDARY Percentage Change From Baseline in F-VASI at Each Post-Baseline Visit |
-11.69; -6.24; -25.57; -14.62; -54.62; -32.43 | — |
| SECONDARY Change From Baseline in T-VASI at Each Post-Baseline Visit |
6.58; 6.87; -0.40; -0.06; -0.85; -0.17 | — |
| SECONDARY Percentage Change From Baseline in T-VASI at Each Post-Baseline Visit |
-6.12; -1.02; -15.21; -2.79; -29.76; -7.88 | — |
| SECONDARY Change From Baseline in Facial Body Surface Area (F-BSA) at Each Post-Baseline Visit |
1.12; 0.96; -0.04; -0.02; -0.08; -0.06 | — |
| SECONDARY Percentage Change From Baseline in F-BSA at Each Post-Baseline Visit |
-4.02; -1.50; -7.25; -4.37; -24.12; -14.83 | — |
| SECONDARY Change From Baseline in Total Body Surface Area (T-BSA) at Each Post-Baseline Visit |
7.00; 7.22; -0.19; -0.02; -0.48; -0.01 | — |
| SECONDARY Percentage Change From Baseline in T-BSA at Each Post-Baseline Visit |
-2.65; -0.36; -7.71; -0.24; -16.92; -2.60 | — |
| SECONDARY Plasma Concentration of Ruxolitinib at Weeks 4, 12, and 16 |
18.7; 51.1; 23.3; 53.7; 49.3; 55.4 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05247489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.