Tofacitinib Ointment For Chronic Plaque Psoriasis

Pfizer

Status and phase: Completed; Phase 2

Conditions: Psoriasis; Psoriasis Vulgaris

Treatments: Drug: tofacitinib ointment 10 mg/g; Drug: placebo ointment (vehicle); Drug: tofacitinib ointment 20 mg/g

Study type: Interventional

Funder types: Industry

Identifiers

NCT01831466

2012-005645-20 (EudraCT Number)

A3921082

Details and patient eligibility

About

The study is beng done to test if tofacitinib ointment is safe and effective for people with plaque psoriasis. Two dose strengths of tofacitinib ointment (20 mg/g and 10 mg/g) applied once or twice daily are being tested. The safety and effectiveness of tofacitinib ointment used for 12 weeks will be compared to the safety and effectiveness of placebo ointment (vehicle) used for 12 weeks.

Enrollment: 476 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline
• At Baseline, have plaque psoriasis covering 2% to 20% of total body surface area (BSA) on the trunk and limbs (excluding palms, soles, and nails)
• If received certain treatments, should be off treatment for a minimum period of time (washout)

Exclusion criteria

• Currently have non-plaque forms of psoriasis or drug-induced psoriasis
• Require treatment with or cannot stop medication(s) prohibited during the study
• Have certain laboratory abnormalities at Baseline
• Current or history of certain infections
• Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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476 participants in 6 patient groups, including a placebo group

Treatment Group A

Experimental group

Treatment:

Drug: tofacitinib ointment 20 mg/g

Drug: tofacitinib ointment 20 mg/g

Treatment Group B

Experimental group

Treatment:

Drug: tofacitinib ointment 10 mg/g

Drug: tofacitinib ointment 10 mg/g

Treatment Group C

Placebo Comparator group

Treatment:

Drug: placebo ointment (vehicle)

Drug: placebo ointment (vehicle)

Treatment Group D

Experimental group

Treatment:

Drug: tofacitinib ointment 20 mg/g

Drug: tofacitinib ointment 20 mg/g

Treatment Group E

Experimental group

Treatment:

Drug: tofacitinib ointment 10 mg/g

Drug: tofacitinib ointment 10 mg/g

Treatment Group F

Placebo Comparator group

Treatment:

Drug: placebo ointment (vehicle)

Drug: placebo ointment (vehicle)