NCT00601107

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

A Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in the Treatment of Subjects With Moderate to Severe Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and effectiveness of an investigational drug called doxercalciferol in participants with moderate to severe chronic plaque psoriasis, in comparison with a placebo ("sugar pill"). All study related care was provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation was 28 weeks.

Detailed description

This was 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 participants with moderate to severe chronic plaque psoriasis. Participants were randomized and stratified by site and Psoriasis Area Severity Index (PASI) score to one of three active treatment groups or to the placebo group.

Conditions

• Moderate to Severe Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Doxercalciferol
DRUG	Placebo

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-02-01
• Completion: 2009-06-01
• First posted: 2008-01-25
• Last updated: 2014-05-05
• Results posted: 2014-05-05

Locations

19 sites across 1 country: United States