A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Patients With Moderate to Severe Psoriasis - Full Text View

Sponsor:	Genzyme
Information provided by:	Genzyme
ClinicalTrials.gov Identifier:	NCT00601107

Purpose

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.

Condition	Intervention	Phase
Moderate to Severe Chronic Plaque Psoriasis	Drug: doxercalciferol Other: N/A - placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Genzyme:

Primary Outcome Measures:

Achievement of at least a 50% reduction in PASI score (PASI 50) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Achievement of PASI 50 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
Achievement of a static PGA score of clear (0) or almost clear (1) [ Time Frame: at week 12 and week 24 ] [ Designated as safety issue: No ]

Enrollment:	136
Study Start Date:	April 2008
Study Completion Date:	June 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dose level 1: Experimental	Drug: doxercalciferol 2.5 mcg capsules(s) taken once daily for 24 weeks
Dose level 2: Experimental	Drug: doxercalciferol 2.5 mcg capsules(s) taken once daily for 24 weeks
Dose level 3: Experimental	Drug: doxercalciferol 2.5 mcg capsules(s) taken once daily for 24 weeks
Placebo group: Placebo Comparator	Other: N/A - placebo placebo capsule(s) taken once daily for 24 weeks

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601107

Show 19 Study Locations

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

Medical Monitor

Genzyme

More Information

No publications provided

Responsible Party:	Genzyme Corporation ( Medical Monitor )
Study ID Numbers:	HECTPS02507
Study First Received:	January 15, 2008
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00601107 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

psoriasis
psoriasis vulgaris
plaque psoriasis
chronic plaque psoriasis

Additional relevant MeSH terms:

1 alpha-hydroxyergocalciferol
Skin Diseases
Psoriasis
Growth Substances
Vitamins
Physiological Effects of Drugs

Ergocalciferols
Bone Density Conservation Agents
Micronutrients
Skin Diseases, Papulosquamous
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009