Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)

Incyte

Status and phase: Completed; Phase 3

Conditions: Non-segmental Vitiligo

Treatments: Drug: Ruxolitinib cream; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04052425

2019-000846-37 (EudraCT Number)

INCB 18424-306

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adolescent and adult participants with non-segmental vitiligo for whom total body involved vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).

Enrollment: 330 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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 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.
• Must be willing to take appropriate contraceptive measures to avoid pregnancy or fathering a child for the duration of study participation.

Key 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).
• Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo or other pigmented areas.
• Use of protocol-defined treatments within the indicated washout period before baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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330 participants in 4 patient groups, including a placebo group

Double-Blind Period: Ruxolitinib cream 1.5% BID

Experimental group

Description:

Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.

Treatment:

Drug: Ruxolitinib cream

Double-Blind Period: Vehicle cream BID

Placebo Comparator group

Description:

Participants applied matching vehicle cream BID for 24 weeks.

Treatment:

Drug: Vehicle

Treatment-Extension Period: Ruxolitinib cream 1.5% BID

Experimental group

Description:

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.

Treatment:

Drug: Ruxolitinib cream

Treatment-Extension Period: Vehicle cream to Ruxolitinib cream 1.5% BID

Experimental group

Description:

Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5%m BID for 28 weeks in the Treatment-Extension Period.

Treatment:

Drug: Vehicle

Drug: Ruxolitinib cream