A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Extension Period in Participants With Vitiligo

Phase 3

Recruiting

• Conditions: leucoderma; white patches of skin; 10040790

• Registration Number: NL-OMON49311
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

- Adolescents and adults aged >= 12 years.
- Participants with a clinical diagnosis of non-segmental vitiligo with
depigmented area including >= 0.5% BSA on the face, >= 0.5 F-VASI, >= 3% BSA on
nonfacial areas, >= 3 T-VASI, and total body vitiligo area (facial and
non-facial) not exceeding 10% BSA.
- Participants who 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

- Participants who have 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).
- Participants who have used depigmentation treatments (eg, monobenzone) for
past treatment of vitiligo or other pigmented areas.
Note: Prior use of hydroquinone is not prohibited (as it is a bleaching agent,
not a depigmentation treatment).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of participants achieving F-VASI75 at Week 24.</p><br>