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

NCT00689481 | Completed Phase 3 Results

• 2 other identifiers: 114742U0267-302
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Psoriasis

Keywords

Plaque-type Psoriasis; psoriasis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment

  Assessment (on a scale of 0 to 4) was made as a visual average of all lesions, except those on the face/scalp. 0=clear; minor residual discoloration; no erythema/scaling/plaque thickness (PT). 1=almost clear; occasional fine scale/faint erythema/barely perceptible PT. 2=mild; fine scales predominate; light red coloration/mild PT. 3=moderate; coarse scales predominate; moderate red coloration/moderate PT. 4=severe; thick tenacious scale predominates; deep red coloration/severe PT. Treatment success=ISGA score 0 or 1, and a minimum improvement in the ISGA score of 2 grades from BL to week 8.

  8 weeks

Secondary Outcomes (5)

• Number of Subjects With a Target Lesion Score of 0 or 1 for Erythema and at Least a 2-grade Improvement From Baseline at Week 8

  8 Weeks

• Number of Subjects With a Target Lesion Score of 0 or 1 for Scaling and at Least a 2-grade Improvement From Baseline at Week 8

  8 Weeks

• Number of Subjects With a Target Lesion Score of 0 for Plaque Thickness at Week 8

  8 Weeks

• Number of Subjects Who Have an ISGA Score of 0 or 1 at Week 8

  8 Weeks

• Number of Subjects Who Have Treatment Success at Week 8 Analyzed by Baseline ISGA (Mild or Moderate)

  8 Weeks

Study Arms (2)

U0267 foam

EXPERIMENTAL

U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Drug: U0267 Foam

Vehicle foam

PLACEBO COMPARATOR

Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.

Drug: Vehicle foam

Interventions

U0267 Foam DRUG

All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

U0267 foam

Vehicle foam DRUG

All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

Vehicle foam

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (12)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Center for Dermatology Cosmetic and Laser Surgery

Fremont, California, 94538, United States

Location

Advanced Dermatology & Cosmetic Surgery

Ormond Beach, Florida, 32175, United States

Location

Adult & Pediatric Dermatology

Overland Park, Kansas, 66211, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

The Center for Dermatology at Lifetime Health

Rochester, New York, 14623, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University Dermatology Consultants, Inc.

Cincinnati, Ohio, 45219, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Clinical Partners, LLC

Johnston, Rhode Island, 02919, United States

Location

The Skin Wellness Center, PC

Knoxville, Tennessee, 37922, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Feldman SR, Matheson R, Bruce S, Grande K, Markowitz O, Kempers S, Brundage T, Wyres M; U0267-301 & 302 Study Investigators. Efficacy and safety of calcipotriene 0.005% foam for the treatment of plaque-type psoriasis: results of two multicenter, randomized, double-blind, vehicle-controlled, phase III clinical trials. Am J Clin Dermatol. 2012 Aug 1;13(4):261-71. doi: 10.2165/11630710-000000000-00000.

  PMID: 22587791 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2008
• First Posted: June 3, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 7, 2016
• Results First Posted: December 8, 2010

Record last verified: 2016-08

Locations

US (12)