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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00601107
First received: January 15, 2008
Last updated: May 4, 2010
Last verified: May 2010
  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
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


Further study details as provided by Genzyme, a Sanofi Company:

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
Experimental: Dose level 1 Drug: doxercalciferol
2.5 mcg capsules(s) taken once daily for 24 weeks
Other Name: Hectorol
Experimental: Dose level 2 Drug: doxercalciferol
2.5 mcg capsules(s) taken once daily for 24 weeks
Other Name: Hectorol
Experimental: Dose level 3 Drug: doxercalciferol
2.5 mcg capsules(s) taken once daily for 24 weeks
Other Name: Hectorol
Placebo Comparator: Placebo group Drug: 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, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00601107     History of Changes
Other Study ID Numbers: HECTPS02507
Study First Received: January 15, 2008
Last Updated: May 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
psoriasis
psoriasis vulgaris
plaque psoriasis
chronic plaque psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 14, 2014