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Doxercalciferol in Moderate to Severe Chronic Plaque Psoriasis
NCT00601107Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2008
- Primary completion
- Feb 2009
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- doxercalciferol
- Conditions
- psoriasis
01
Overview
Phase 2, randomised, double-blind trial of doxercalciferol in psoriasis (4 arms), sponsored by Sanofi. Primary endpoint: Percentage of Participants With at Least 50 Percent Reduction in Psoriasis Area Severity Index Score at Week 12. Started Apr 2008; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Doxercalciferol 2.5 mcg/day
Doxercalciferol 2.5 mcg capsule orally once daily.
Doxercalciferol 5 mcg/day
Doxercalciferol 5 mcg capsules orally once daily.
Doxercalciferol 7.5 mcg/day
Doxercalciferol 7.5 mcg capsules orally once daily.
Placebo
Matching placebo capsules orally once daily.
03
Who it enrols
Participants with moderate to severe chronic plaque psoriasis (BSA >= 10%, PASI >= 10, PGA moderate/severe) who are candidates for systemic therapy and have no significant renal or hepatic impairment.
04
Endpoints
Primary
Percentage of Participants With at Least 50 Percent Reduction in Psoriasis Area Severity Index Score at Week 12
Secondary
Percentage of Participants With at Least 50 Percent Reduction in Psoriasis Area Severity Index Score at Week 24
Percentage of Participants With Static Physician's Global Assessment Score of Clear or Almost Clear
05
Results
Not all primary endpoints met
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