NCT01831466

Tofacitinib Ointment For Chronic Plaque Psoriasis

A Phase 2b, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Efficacy, Safety, Local Tolerability And Pharmacokinetics Of 2 Dose Strengths And 2 Regimens Of Tofacitinib Ointment In Subjects With Chronic Plaque Psoriasis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 476 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Psoriasis Vulgaris
• Psoriasis

Interventions

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

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-04-15
• Last updated: 2015-11-25
• Results posted: 2015-11-25

Locations

54 sites across 4 countries: United States, Canada, Denmark, Poland