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.
tofacitinib ointment 20 mg/g
+ tofacitinib ointment 10 mg/g
+ placebo ointment (vehicle)
Hemic and Lymphatic Diseases+15
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.476 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.6 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
PlaceboGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 54 locations
Burke Pharmaceutical Research
Hot Springs, United StatesOpen Burke Pharmaceutical Research in Google MapsBakersfield Dermatology and Skin Cancer Medical Center
Bakersfield, United StatesUC Irvine Dermatology Research
Irvine, United StatesDermatology Research Associates
Los Angeles, United States