Tofacitinib Ointment For Chronic Plaque Psoriasis

Conditions

• Psoriasis
• Psoriasis Vulgaris

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• tofacitinib ointment 20 mg/g — DRUG
  tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
• tofacitinib ointment 10 mg/g — DRUG
  tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
• placebo ointment (vehicle) — DRUG
  placebo ointment (vehicle) BID (twice daily) for 12 weeks
• tofacitinib ointment 20 mg/g — DRUG
  tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
• tofacitinib ointment 10 mg/g — DRUG
  tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
• placebo ointment (vehicle) — DRUG
  placebo ointment (vehicle) QD (once daily) for 12 weeks

Study Details

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.

Key Dates

Start date

May 31, 2013

Status verified

Oct 2015

Primary completion

Sep 30, 2014

Completion

Sep 30, 2014

Study Design

Enrollment

476 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Group A
• Experimental: Treatment Group B
• Placebo Comparator: Treatment Group C
• Experimental: Treatment Group D
• Experimental: Treatment Group E
• Placebo Comparator: Treatment Group F

Primary Outcome Measure

Percentage of Participants Achieving a PGA-C Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to (≥) 2 Grade/Point Improvement From Baseline at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (29)

Find similar trials in Hot Springs, AR

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