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Sotrastaurin in plaque psoriasis
NCT00885196Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2009
- Primary completion
- Aug 2011
- Countries
- 9
- Sponsor
- Novartis
- Modality
- Small Molecules
- Drugs
- sotrastaurin
- Conditions
- plaque psoriasis
01
Overview
Phase 2, randomised, double-blind trial of sotrastaurin in plaque psoriasis (4 arms), sponsored by Novartis. Primary endpoints: Psoriasis Area and Severity Index 75 Response at 12 weeks and Change from Baseline in Psoriasis Area and Severity Index at 12 weeks. Started Apr 2009; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
AEB071 200 mg BID
AEB071 200 mg twice daily
AEB071 400 mg OD
AEB071 400 mg once daily
AEB071 300 mg BID
AEB071 300 mg twice daily
Placebo BID
Placebo twice daily
03
Who it enrols
Patients with moderate to severe plaque psoriasis (PASI >= 10, BSA >= 10%, IGA >= 3) requiring systemic therapy. Excludes patients with significant cardiac abnormalities or history of malignancy.
04
Endpoints
Primary
Psoriasis Area and Severity Index 75 Response
Change from Baseline in Psoriasis Area and Severity Index
Secondary
Rates of Adverse Events
Electrocardiogram Parameters
Change in Investigator's Global Assessment
Disease Recurrence (PASI, IGA)
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