Safety and Efficacy of BFH772 in Psoriasis Patients
Phase 1
Completed
- Conditions
- PsoriasisArthritis
- Interventions
- Registration Number
- NCT00987870
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Stable mild to moderate plaque psoriasis (BSA involvement < 10% or PASI < 10
- Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
- Diagnosed or history of psoriasis for at least 6 months prior to screening
Exclusion Criteria
- Nonplaque forms of psoriasis
- Drug-induced psoriasis
- Current use of beta blockers
- Congestive heart failure (NYHA >III), QT interval >450msec or poorly controlled diabetes mellitus
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BFH772 cream 1% BFH772 - BFH772 ointment 1% BFH772 - Placebo to BFH772 cream 1% Placebo - Placebo to BFH772 ointment Placebo - calcipotriol/betamethasone ointment calcipotriol/betamethasone -
- Primary Outcome Measures
Name Time Method Measure: Plaque PASI score 4 weeks
- Secondary Outcome Measures
Name Time Method Measure: Local tolerability Time Frame: baseline (predose Day 1) and 1h, 3h, 6h after the morning dose, then before each application (morning and evening) until the morning application on Day 5 and then at each visit before the morning application, and at study completion Measure: BFH772 concentration in plasma Day 1: Pre-dose; 4h post dose. Measure: BFH772 concentration in skin Week 4
Trial Locations
- Locations (1)
Novartis Investigator Site
🇩🇪Berlin, Germany