Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

September 26, 2014 updated by: OPKO Health, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Radiant Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Dermatology Research of Arkansas PLLC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Radiant Research, Kansas City
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Mass General/ Brigham & Women's
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Department of Dermatology, Mayo Clinic
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • UMDNJ-Robert Wood Johnson Medical School
    • New York
      • New York, New York, United States, 10016
        • New York University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • Williamsville, New York, United States, 14221
        • Buffalo Medical Group PC
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinatti, Ohio, United States, 45249
        • Radiant Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Paddington Testing Co.
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Radiant Research Inc.
      • Greenville, South Carolina, United States, 29607
        • Palmetto Clinical Trial Services LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint will be treatment success or failure based on a Physician's Static Global Assessment (PSGA) of 0 or 1 (success).

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO Health, Inc.

Investigators

  • Study Director: Joel Melnick, MD, OPKO Renal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

October 2, 2006

First Submitted That Met QC Criteria

October 2, 2006

First Posted (Estimate)

October 4, 2006

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTA018-CL-2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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