Phase 2
N=60
A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA)
Vitiligo
Bottom Line
View on ClinicalTrials.gov: NCT04896385 ↗Enrolled (actual)
60
Serious AEs
1.4%
Results posted
Dec 2023
Primary outcome: Primary: Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 — -20.93; 8.13; -18.33; 21.13 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib cream (Drug); Vehicle Cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24 |
-20.93; 8.13; -18.33; 21.13; -12.92; 22.17 | — |
| SECONDARY Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts |
-0.34; 0.15; -0.43; 0.02 | 0.004 sig |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period |
19; 7 | — |
| SECONDARY Number of Participants With TEAEs During the Treatment-Extension Period |
12; 3 | — |
| SECONDARY Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period |
1; 0 | — |
| SECONDARY Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period |
0; 1 | — |
Summary
The purpose of the study is to evaluate the Mechanism Of Action (MOA) of ruxolitinib cream in vitiligo by assessing the change in biomarkers.
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of nonsegmental vitiligo with depigmented areas including ≥ 0.5% BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, and ≥ 3 T-VASI; total body vitiligo area (facial and nonfacial) should not exceed 50% BSA.
- At least 1 active vitiligo lesion (eg, such as confetti lesion, trichrome appearance, pinkish rim, or other evidence of inflammatory activity) at the site for skin biopsy.
- 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 (eg, piebaldism, pityriasis alba, leprosy, postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor).
- Used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas except hydroquinone.
- Any other skin disease that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
- Conditions at baseline that would interfere with evaluation of vitiligo.
- Use of any protocol-defined treatments within the indicated washout period before baseline.
Data sourced from ClinicalTrials.gov (NCT04896385). 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.