Conditions: Moderate to Severe Chronic Plaque Psoriasis
Keywords: psoriasis psoriasis vulgaris plaque psoriasis chronic plaque psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 111
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24. arm 2: Doxercalciferol 5 mcg capsules orally once daily up to Week 24. arm 3: Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24. arm 4: Placebo matching to doxercalciferol capsules orally once daily up to Week 24.

Interventions: intervention 1: Doxercalciferol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: