A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis

Incyte

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Other: Placebo Cream; Drug: Ruxolitinib Phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778700

INCB 18424-203

Details and patient eligibility

About

The study was double-blind, randomized, vehicle-controlled study with application of Ruxolitinib phosphate cream or vehicle cream in participants with stable plaque psoriasis applied once daily for 12 weeks without occlusive dressings. There were 4 treatment groups anticipated to have 50 participants in each.

Enrollment: 199 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Plaque psoriasis involving up to 2 to 20% Body Surface Area

Exclusion criteria

• Lesions solely involving intertriginous areas, the scalp or the face
• Systemic therapy for their psoriasis
• Pustular psoriasis or erythroderma
• Currently on other topical agents or Ultraviolet B (UVB) therapy within 2 weeks of the first dose of study medication
• Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis
• Receiving systemic triazole antifungals except fluconazole

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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199 participants in 4 patient groups, including a placebo group

Vehicle Cream

Placebo Comparator group

Description:

Vehicle cream, applied topically, once daily from Day 1 to Week 12.

Treatment:

Other: Placebo Cream

Ruxolitinib Phosphate 0.5% Cream

Experimental group

Description:

Ruxolitinib phosphate 0.5% cream, applied topically, once daily from Day 1 to Week 12.

Treatment:

Drug: Ruxolitinib Phosphate

Ruxolitinib Phosphate 1.0% Cream

Experimental group

Description:

Ruxolitinib phosphate 1.0% cream, applied topically, once daily from Day 1 to Week 12.

Treatment:

Drug: Ruxolitinib Phosphate

Ruxolitinib Phosphate 1.5% Cream

Experimental group

Description:

Ruxolitinib phosphate 1.5% cream, applied topically, once daily from Day 1 to Week 12.

Treatment:

Drug: Ruxolitinib Phosphate