Overview

This trial is active, not recruiting.

Conditions psoriasis vulgaris, psoriasis
Treatments tofacitinib ointment 20 mg/g, tofacitinib ointment 10 mg/g, placebo ointment (vehicle)
Phase phase 2
Sponsor Pfizer
Start date May 2013
End date October 2014
Trial size 480 participants
Trial identifier NCT01831466, A3921082

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
(Experimental)
tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
(Placebo Comparator)
placebo ointment (vehicle)
placebo ointment (vehicle) BID (twice daily) for 12 weeks
(Experimental)
tofacitinib ointment 20 mg/g
tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
(Experimental)
tofacitinib ointment 10 mg/g
tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
(Placebo Comparator)
placebo ointment (vehicle)
placebo ointment (vehicle) QD (once daily) for 12 weeks

Primary Outcomes

Measure
Calculated Physician Global Assessment (PGA-C) of Psoriasis Score
time frame: Week 12
Calculated Physician Global Assessment (PGA-C) of Psoriasis Score
time frame: Week 8

Secondary Outcomes

Measure
Calculated Physician Global Assessment (PGA-C) of Psoriasis Score
time frame: Week 12
Calculated Physician Global Assessment (PGA-C) of Psoriasis Score
time frame: Week 8
Gestalt Physician's Global Assessment (PGA-G) of Psoriasis Score
time frame: Week 12
Gestalt Physician's Global Assessment (PGA-G) of Psoriasis Score
time frame: Week 8
Change in Psoriasis Area and Severity Index (PASI)
time frame: Baseline, Week 12
Change in Psoriasis Area and Severity Index (PASI)
time frame: Baseline, Week 8
Psoriasis Area and Severity Index 75 (PASI75)
time frame: Week 12
Psoriasis Area and Severity Index 75 (PASI75)
time frame: Week 8
Change in Body Surface Area (BSA) affected with psoriasis
time frame: Baseline, Week 12
Change in Body Surface Area (BSA) affected with psoriasis
time frame: Baseline, Week 8

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Pfizer.