A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Patients With Moderate to Severe Psoriasis
Information source: Genzyme
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Moderate to Severe Chronic Plaque Psoriasis
Intervention: doxercalciferol (Drug); doxercalciferol (Drug); doxercalciferol (Drug); N/A - placebo (Other)
Phase: Phase 2
Status: Recruiting
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
David Davidson, MD, Study Director, Affiliation: Genzyme Corportation
Overall contact:
Medical Information, Phone: 800-745-4447, Email: MedInfo@genzyme.com
Summary
The aim of this study is to evaluate the safety and effectiveness of an investigational drug
called doxercalciferol in patients with moderate to severe chronic plaque psoriasis, in
comparison with a placebo ("sugar pill"). All study related care is provided including
doctor visits, physical exams, laboratory tests and study medication. Total length of
participation is 28 weeks.
Clinical Details
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in the Treatment of Subjects Wtih Moderate to Severe Chronic Plaque Psoriasis.
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Achievement of at least a 50% reduction in PASI score (PASI 50)
Secondary outcome: Achievement of PASI 50Achievement of a static PGA score of clear (0) or almost clear (1)
Detailed description:
This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel
group study to evaluate the efficacy and safety of doxercalciferol given orally, once daily
for 24 weeks to patients with moderate to severe chronic plaque psoriasis. Subjects will be
randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of
three active treatment groups or to the placebo group.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject must have moderate to severe chronic plaque psoriasis with a body surface area
(BSA) involvement ≥10%.
- Subject must have static PGA of moderate or severe.
- Subject must have a minimum PASI score of ≥10.
Exclusion Criteria:
- Use of drugs known to influence serum calcium (such as lithium, digoxin, thiazide
diuretics, teriparatide, bisphosphonates, and calcitonin) and multivitamin supplements
containing >400 IU vitamin D or calcium and/or calcium-containing antacids exceeding a
total of 1 gram/day.
- Use of other psoriasis medications or light therapy during the study except for
shampoos containing coal tar or salicylic acid and low potency topical corticosteroids
(Classes VI and VII) on the groin, scalp, palms, soles and face.
- History of kidney stones, chronic kidney disease, symptomatic coronary or cerebral
vascular disease, HIV, active viral hepatitis, or any other clinically significant,
unstable medical condition that would interfere with the completion of the study.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A
history of malignancy is not an exclusion.
- Active ethanol or drug abuse.
- Pregnant or breast-feeding women.
Locations and Contacts
Medical Information, Phone: 800-745-4447, Email: MedInfo@genzyme.com
Birmingham, Alabama, United States; Recruiting
Hot Springs, Arizona, United States; Recruiting
Little Rock, Arkansas, United States; Recruiting
Santa Monica, California, United States; Recruiting
Irvine, California, United States; Recruiting
Alpharetta, Georgia, United States; Recruiting
Indianapolis, Indiana, United States; Recruiting
Andover, Massachusetts, United States; Recruiting
Boston, Massachusetts, United States; Recruiting
West Bloomfield, Michigan, United States; Recruiting
Troy, Michigan, United States; Recruiting
St. Louis, Missouri, United States; Recruiting
East Windsor, New Jersey, United States; Recruiting
Albuquerque, New Mexico, United States; Recruiting
Stony Brook, New York, United States; Recruiting
Greer, South Carolina, United States; Recruiting
Nashville, Tennessee, United States; Recruiting
San Antonio, Texas, United States; Recruiting
Salt Lake City, Utah, United States; Recruiting
Additional Information
FDA approved Full Prescribing Information for Hectorol capsules
Starting date: April 2008
Ending date: April 2009
Last updated: August 20, 2008
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