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Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies

A Multicenter, Randomized, Double-Blind, Phase 3 Study of the Safety and Efficacy of Emulsion Formulation U0267, Versus Vehicle in Subjects With Plaque-type Psoriasis

NCT00688519•Stiefel, a GSK Company

View on ClinicalTrials.gov

Summary

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female subjects at least 12 years old and in good general health.
•Mild to moderate plaque-type psoriasis

Exclusion Criteria

•Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
•History of hypercalcemia or of vitamin D toxicity.
•Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
•Other serious skin disorder or any chronic medical condition that is not well controlled.
•Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
•Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
•Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
•Use of any investigational therapy within 4 weeks of enrollment.
•Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.

Locations (13)

Therapeutics Clinical Research Center, Inc.

San Diego, California, United States

Cherry Creek Research, Inc.

Denver, Colorado, United States

Florida Academic Dermatology Centers

Miami, Florida, United States

FXM Research

Miami, Florida, United States

DermResearch, PLLC

Louisville, Kentucky, United States

Massachusetts General Hospital Clinical Unit for Research Trials in Skin

Boston, Massachusetts, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Mount Sinai School of Medicine, Department of Dermatology

New York, New York, United States

Dermatology Consulting Services

High Point, North Carolina, United States

Oregon Medical Research Center, P.C.

Portland, Oregon, United States

Key Dates

Start Date

March 1, 2008

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

January 2, 2017

Enrollment

336

ACTUAL participants

Conditions

Psoriasis

Interventions

U0267

DRUG

Vehicle

DRUG

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

NCT07449234

Psoriasis

View study

RECRUITINGPHASE3

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

View study

RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 2, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments