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

NCT05247489 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 18424-217
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 13

Brief 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).

Conditions

Vitiligo

Keywords

Non-segmental; Vitiligo; hypopigmentation; Pigment Disorders; Skin Diseases; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Body Vitiligo Area Scoring Index (T-VASI) at Week 48

  T-VASI was calculated with contributions from 6 body sites. The percentage of vitiligo involvement was estimated in hand units (percentage of body surface area \[BSA\] estimated to nearest 0.1%) by the Investigator using the Palmar Method. The Investigator used his/her hand to mimic the participant's hand size to evaluate percent BSA vitiligo involvement. The degree of depigmentation for each body site was estimated to the nearest percentage: 0% (no depigmentation present), 10% (only specks of depigmentation present), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment present), 100% (no pigment present). T-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each body site and summing the values (range: 0-100; lower scores indicate increased improvement).

  Baseline; Week 48

Secondary Outcomes (16)

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE)

  up to approximately 52 weeks

• Percentage of Participants Achieving a ≥50% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI50) Score at Each Post-Baseline Visit

  Baseline; up to Week 48

• Percentage of Participants Achieving a ≥75% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI75) Score at Each Post-Baseline Visit

  Baseline; up to Week 48

• Percentage of Participants Achieving a ≥90% Improvement From Baseline in the Face Vitiligo Area Scoring Index (F-VASI90) Score at Each Post-Baseline Visit

  Baseline; up to Week 48

• 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

  Baseline; up to Week 48

Study Arms (2)

Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)

EXPERIMENTAL

Participants will initially apply ruxolitinib 1.5%mg cream as a monotherapy. At week 12, those who have \< 25% improvement in total body Vitiligo Area Scoring Index (T-VASI25) will have NB-UVB phototherapy added to their ruxolitinib 1.5% cream BID regimen. NB-UVB will be given 3 times per week starting at Week 12 through Week 48 (36 weeks). For participants who receive combination therapy, NB-UVB machines will be supplied by the sponsor for at home use during the study.

Drug: Ruxolitinib 1.5% cream; Device: NB-UVB phototherapy

Group B: Ruxolitinib Monotherapy

EXPERIMENTAL

Participants will apply ruxolitinib 1.5% cream BID as monotherapy. Participants who have ≥ T-VASI25 at Week 12 will continue on ruxolitinib 1.5% cream BID alone.

Drug: Ruxolitinib 1.5% cream

Interventions

Ruxolitinib 1.5% cream DRUG

Ruxolitinib cream 1.5% applied twice a day (BID).

Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB); Group B: Ruxolitinib Monotherapy

NB-UVB phototherapy DEVICE

NB-UVB (311-312 nm) phototherapy is an established treatment modality for vitiligo. Starting dose will be 200 mJ/cm2 and dose may be increased by 10% at each visit

Also known as: Narrow-Band Ultraviolet B Phototherapy

Group A: Ruxolitinib + Narrow-Band Ultraviolet B Phototherapy (NB-UVB)

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (13)

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

UC Davis Health

Sacramento, California, 95816, United States

Location

Palo Alto Medical Foundation

Sunnyvale, California, 94086, United States

Location

Delricht Clinical Research - Clinedge - Ppds Baton Rouge

Baton Rouge, Louisiana, 70809, United States

Location

Aesthetic and Dermatology Center

Rockville, Maryland, 20850, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Metro Boston Clinical Partners

Brighton, Massachusetts, 02135, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

Henry Ford Medical Center - New Center One

Detroit, Michigan, 48202, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, 78660, United States

Location

Principle Research Solutions

Spokane, Washington, 99202, United States

Location

Simcomed Health Ltd

Barrie, Ontario, L4M 7G1, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

MeSH Terms

Conditions

Vitiligo; Hypopigmentation; Pigmentation Disorders; Skin Diseases

Interventions

ruxolitinib

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Study Officials

• Haq Nawaz, MD

  Incyte Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 21, 2022
• Study Start: May 5, 2022
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

US (11); CA (2)