A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

NCT03099304 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 18424-211
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.

Conditions

Vitiligo

Keywords

Vitiligo; depigmenting disorder; topical JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Treated With Ruxolitinib Cream Who Achieved a ≥ 50% Improvement From Baseline in Facial Assessment of the Vitiligo Area and Severity Index Score (F-VASI50) Compared With Participants Treated With Vehicle at Week 24

  An F-VASI50 responder achieved at least 50% improvement from Baseline in F-VASI, measured by the percentage of vitiligo involvement (percentage of body surface area \[BSA\]) and the degree of depigmentation: 0% (no depigmentation), 10% (only specks of depigmentation), 25% (pigmented area exceeded depigmented area), 50% (depigmented and pigmented area was equal), 75% (depigmented area exceeded pigmented area), 90% (specks of pigment), or 100% (no pigment). The percentage of BSA (hand unit) vitiligo involvement was estimated to the 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 the percentage of BSA vitiligo involvement. F-VASI was then derived by multiplying the values assessed for the vitiligo involvement by the percentage of affected skin for each site on the face and summing the values of all sites (possible range: 0-3; lower scores indicate increased improvement).

  Baseline; Week 24

Secondary Outcomes (48)

• Percentage of Participants Who Achieved a Facial Assessment of the Physician's Global Vitiligo Assessment (F-PhGVA) of Clear or Almost Clear

  Week 24

• Percentage of Participants Who Achieved a ≥ 50% Improvement From Baseline in Full Body Assessment of Vitiligo Area and Severity Index (T-VASI) at Week 52

  Baseline; Week 52

• Dose Response on Percentage Change From Baseline in F-VASI

  up to 156 weeks

• Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Grade 3 or Higher TEAE up to Week 24

  up to 24 weeks

• Number of Participants With Any TEAE and Any Grade 3 or Higher TEAE up to Week 52

  up to 52 weeks

Study Arms (5)

Ruxolitinib cream 1.5% twice daily (BID)

EXPERIMENTAL

Ruxolitinib cream 1.5% BID for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.

Drug: Ruxolitinib cream

Ruxolitinib cream 1.5% once daily (QD)

EXPERIMENTAL

Ruxolitinib cream 1.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.

Drug: Ruxolitinib cream; Drug: Vehicle cream

Ruxolitinib cream 0.5% QD

EXPERIMENTAL

Ruxolitinib cream 0.5% QD in the morning (vehicle cream in the evening) for 52 weeks, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.

Drug: Ruxolitinib cream; Drug: Vehicle cream

Ruxolitinib cream 0.15% QD

EXPERIMENTAL

Ruxolitinib cream 0.15% QD in the morning (vehicle cream in the evening) for 52 weeks (opportunity for re-randomization to a higher dose at Week 24 if \< 25% improvement in F-VASI score), followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.

Drug: Ruxolitinib cream; Drug: Vehicle cream

Vehicle BID

PLACEBO COMPARATOR

Vehicle cream BID for 24 weeks, followed by re-randomization to ruxolitinib cream 1.5% BID, 1.5% QD, or 0.5% QD for Weeks 24 to 52, followed by ruxolitinib cream 1.5% BID in a 104-week open-label extension.

Drug: Ruxolitinib cream; Drug: Vehicle cream

Interventions

Ruxolitinib cream DRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Also known as: INCB018424 cream

Ruxolitinib cream 0.15% QD; Ruxolitinib cream 0.5% QD; Ruxolitinib cream 1.5% once daily (QD); Ruxolitinib cream 1.5% twice daily (BID); Vehicle BID

Vehicle cream DRUG

Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

Ruxolitinib cream 0.15% QD; Ruxolitinib cream 0.5% QD; Ruxolitinib cream 1.5% once daily (QD); Vehicle BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of vitiligo.
• Vitiligo with depigmented areas including:
• at least 0.5% of the total body surface area (BSA) on the face (0.5% BSA is approximately equal to the area of the participant's palm \[without digits\]) AND
• at least 3% of the total BSA on nonfacial areas (3% BSA is approximately equal to the area of 3 of the participant's handprints \[palm plus 5 digits\]).
• Participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. Over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted.

You may not qualify if:

• Conditions at baseline that would interfere with evaluation of vitiligo.
• Participants who are receiving any kind of phototherapy, including tanning beds.
• Participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation.
• Participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas.
• Participants who have received any of the following treatments within the minimum specified timeframes.
• Use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening.
• Use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening.
• Use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening.
• Use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening.
• Participants with a clinically significant abnormal thyroid-stimulating hormone or free T4 at screening.
• Participants with protocol-defined cytopenias at screening
• Participants with severely impaired liver function.
• Participants with impaired renal function.
• Participants taking potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit.
• Participants who have previously received JAK inhibitor therapy, systemic or topical.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (26)

UNIVERSITY OF ALABAMA AT BIRMINGHAM (UAB), 1802 6th Ave S

Birmingham, Alabama, 35233, United States

Location

BURKE PHARMACEUTICAL RESEARCH LLC, 3633 Central Ave

Hot Springs, Arkansas, 71913, United States

Location

NORTHWEST AR CLINICAL TRIALS CENTER, PLLC/HULL DERMATOLOGY, PA, 500 S 52nd Street

Rogers, Arkansas, 72758, United States

Location

THE VITILIGO & PIGMENTATION INSTITUE OF SOUTHERN CALIFORNIA, 5670 Wilshire Boulevard

Los Angeles, California, 90036, United States

Location

DERMATOLOGY RESEARCH ASSOCIATES- LOS ANGELES, 8930 S Sepulveda Blvd

Los Angeles, California, 90045, United States

Location

DERMATOLOGY SPECIALISTS, 3629 Vista Way

Oceanside, California, 92056, United States

Location

CLINICAL RESEARCH CENTER OF CT, 27 Hospital Avenue

Danbury, Connecticut, 06810, United States

Location

LEAVITT MEDICAL ASSOCIATES OF FLORIDA INC/ AMERIDERM RESEARCH, 725 W Granada Blvd

Ormond Beach, Florida, 32174, United States

Location

EMORY UNIVERSITY, 1525 Clifton Road

Atlanta, Georgia, 30322, United States

Location

NORTHWESTERN UNIVERSITY, 676 N Saint Clair

Chicago, Illinois, 60611, United States

Location

DAWES FRETZIN CLINICAL RESEARCH GROUP, 8103 Clearvista Parkway

Indianapolis, Indiana, 46256, United States

Location

DS RESEARCH, 2241 Green Valley Road

New Albany, Indiana, 47150, United States

Location

TULANE UNIVERSITY, 1415 Tulane Avenue

New Orleans, Louisiana, 70112, United States

Location

Tufts Medical Center, 260 Tremont Street

Boston, Massachusetts, 02111, United States

Location

UNIVERSITY OF MASSACHUESETTS, 364 Plantation Street

Worcester, Massachusetts, 01605, United States

Location

HAMZAVI DERMATOLOGY, 3031 W Grand Blvd

Detroit, Michigan, 48059, United States

Location

WASHINGTON UNIVERSITY SCHOOL OF MEDICINE DERMATOLOGY, 969 N. Mason Road

St Louis, Missouri, 63141, United States

Location

ACTIVMED PRACTICES & RESEARCH, INC, 110 Corporate Drive

Portsmouth, New Hampshire, 03801, United States

Location

ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI MEDICAL CENTER- DERMATOLOGY ASSOCIATES, 5 E 98th Street

New York, New York, 11209, United States

Location

WAKE FOREST UNIVERSITY HEALTH SCIENCES, Medical Center Boulevard

Winston-Salem, North Carolina, 27157, United States

Location

CENTRAL SOONER RESEARCH, 900 N Porter Ave

Norman, Oklahoma, 73071, United States

Location

RHODE ISLAND HOSPITAL, 593 Eddy Street

Providence, Rhode Island, 02903, United States

Location

ARLINGTON RESEARCH CENTER, INC., 711 East Lamar Boulevard

Arlington, Texas, 76011, United States

Location

MENTER DERMATOLOGY RESEARCH INSTITUTE, 3900 Junius Street

Dallas, Texas, 75246, United States

Location

UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER, DEPARTMENT OF DERMATOLOGY, 5323 Harry Hines Blvd

Dallas, Texas, 75390, United States

Location

THE DERMATOLOGY AND LASER CENTER OF SAN ANTONIO, 7810 Louis Pasteur

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Howell MD, Kuo FI, Rumberger B, Boarder E, Sun K, Butler K, Harris JE, Grimes P, Rosmarin D. Baseline Levels of Circulating Inflammatory Biomarkers Stratify Patients with Vitiligo Who Significantly Repigment after Treatment with Ruxolitinib Cream. JID Innov. 2023 Sep 13;3(6):100230. doi: 10.1016/j.xjidi.2023.100230. eCollection 2023 Nov.

  PMID: 37840766 DERIVED

• Rosmarin D, Pandya AG, Lebwohl M, Grimes P, Hamzavi I, Gottlieb AB, Butler K, Kuo F, Sun K, Ji T, Howell MD, Harris JE. Ruxolitinib cream for treatment of vitiligo: a randomised, controlled, phase 2 trial. Lancet. 2020 Jul 11;396(10244):110-120. doi: 10.1016/S0140-6736(20)30609-7.

  PMID: 32653055 DERIVED

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Incyte Corporation Call Center (US)
• Organization: Incyte

medinfo@incyte.com

1.855.463.3463

Study Officials

• Kathleen Butler, 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: June 7, 2017
• Primary Completion: September 12, 2018
• Study Completion: September 8, 2021
• Last Updated: November 17, 2022
• Results First Posted: December 10, 2021

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)