A Study of INCB018424 Phosphate Cream in Subjects With Vitiligo

Incyte

Status and phase: Completed; Phase 2

Conditions: Vitiligo

Treatments: Drug: Ruxolitinib cream; Drug: Vehicle cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03099304

INCB 18424-211

Details and patient eligibility

About

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

Enrollment: 157 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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157 participants in 5 patient groups, including a placebo group

Ruxolitinib cream 1.5% twice daily (BID)

Experimental group

Description:

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

Treatment:

Drug: Ruxolitinib cream

Ruxolitinib cream 1.5% once daily (QD)

Experimental group

Description:

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.

Treatment:

Drug: Vehicle cream

Drug: Ruxolitinib cream

Ruxolitinib cream 0.5% QD

Experimental group

Description:

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.

Treatment:

Drug: Vehicle cream

Drug: Ruxolitinib cream

Ruxolitinib cream 0.15% QD

Experimental group

Description:

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.

Treatment:

Drug: Vehicle cream

Drug: Ruxolitinib cream

Vehicle BID

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle cream

Drug: Ruxolitinib cream