Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

Psoriasis Clinical Trial

Official title:

A Randomized, Double-blind, Parallel-group, 4-arm, 12-week Study to Evaluate the Safety and Efficacy of Topically Applied CTA018 vs Vehicle for the Treatment of Adult Subjects With Chronic Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384098
• Other study ID #: CTA018-CL-2001
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2006
• Last updated: September 26, 2014
• Start date: September 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2007
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet

• at least two evaluable plaques with CPSS >/= 6

• baseline PSGA >/= 2

• women of childbearing potential msut agree to use an effective form of contraception

Exclusion Criteria:

• cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis

• cannot have concomitant serious illness/condition that may interfere with participation in the study

• cannot have used topical therapy within 2 weeks prior to baseline visit

• cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit

• cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study

• cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit

• cannot have a history of hypercalcemia or kidney stones

• cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study

• cannot be pregnant or a nursing mother

• cannot be participating in or have participated in an interventional study within 30 days of study start

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CTA018 cream

Locations

Country	Name	City	State
United States	Radiant Research Inc.	Anderson	South Carolina
United States	Mass General/ Brigham & Women's	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Radiant Research	Cincinatti	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Palmetto Clinical Trial Services LLC	Greenville	South Carolina
United States	Dermatology Research of Arkansas PLLC	Little Rock	Arkansas
United States	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University Medical Center	New York	New York
United States	Radiant Research, Kansas City	Overland Park	Kansas
United States	Paddington Testing Co.	Philadelphia	Pennsylvania
United States	Department of Dermatology, Mayo Clinic	Rochester	Minnesota
United States	Radiant Research	Tucson	Arizona
United States	Buffalo Medical Group PC	Williamsville	New York
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).
Secondary	Secondary efficacy outcomes include time to success (PSGA), change in overall PSGA score, and Area Adjusted Psoriasis Area and Severity Index (AAPASI)changes from baseline.