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Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

Primary Purpose

Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CTA018 cream
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiant Research
  • Dermatology Research of Arkansas PLLC
  • Northwestern University
  • Radiant Research, Kansas City
  • Mass General/ Brigham & Women's
  • Department of Dermatology, Mayo Clinic
  • UMDNJ-Robert Wood Johnson Medical School
  • New York University Medical Center
  • Mount Sinai School of Medicine
  • Buffalo Medical Group PC
  • Wake Forest University Health Sciences
  • Radiant Research
  • University Hospitals of Cleveland
  • Paddington Testing Co.
  • Radiant Research Inc.
  • Palmetto Clinical Trial Services LLC

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
October 2, 2006
Last Updated
September 26, 2014
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00384098
Brief Title
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CTA018 cream
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Melnick, MD
Organizational Affiliation
OPKO Renal
Official's Role
Study Director
Facility Information:
Facility Name
Radiant Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Dermatology Research of Arkansas PLLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Radiant Research, Kansas City
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Mass General/ Brigham & Women's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Department of Dermatology, Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
UMDNJ-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Buffalo Medical Group PC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Radiant Research
City
Cincinatti
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Paddington Testing Co.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Radiant Research Inc.
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Palmetto Clinical Trial Services LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

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