Completed

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.

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

tofacitinib ointment 20 mg/g

+ tofacitinib ointment 10 mg/g

+ placebo ointment (vehicle)

Drug
Who is being recruted

Hemic and Lymphatic Diseases+15

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorPfizer
Last updated: November 25, 2015
Sourced from a government-validated database.Claim as a partner

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.

NCT01831466
Principal SponsorPfizer
Last updated: November 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

476 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeSigns and SymptomsSkin ManifestationsPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesSkin Diseases, PapulosquamousLymphoma, FollicularPruritusPsoriasisSkin Diseases

Criteria

3 inclusion criteria required to participate
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)

Have mild, moderate or severe plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline

If received certain treatments, should be off treatment for a minimum period of time (washout)

5 exclusion criteria prevent from participating
Current or history of certain infections

Currently have non-plaque forms of psoriasis or drug-induced psoriasis

Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception

Have certain laboratory abnormalities at Baseline

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Group IV

Experimental

Group 5

Experimental

Group 6

Placebo

Study 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 Maps

Bakersfield Dermatology and Skin Cancer Medical Center

Bakersfield, United States

UC Irvine Dermatology Research

Irvine, United States

Dermatology Research Associates

Los Angeles, United States
Completed54 Study Centers