CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 476 enrolled
Drug / intervention
tofacitinib ointment 20 mg/g +5 moredrug
Likely dose
tofacitinib ointment 20 mg/gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01831466
NCT01831466Phase 2Completed

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.

Pfizer·interventional·Posted Apr 15, 2013·Updated Nov 25, 2015

In Brief

A Phase 2 clinical trial evaluating tofacitinib ointment 20 mg/g, tofacitinib ointment 10 mg/g, and 1 other intervention for Psoriasis Vulgaris and Psoriasis. Completed, enrolled 476 participants across 54 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Denmark, Poland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2013
Enrollment StartMay 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.2 years ago

Interventions

tofacitinib ointment 20 mg/gdrug

tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks

tofacitinib ointment 10 mg/gdrug

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/gdrug

tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks

tofacitinib ointment 10 mg/gdrug

tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks

placebo ointment (vehicle)drug

placebo ointment (vehicle) QD (once daily) for 12 weeks