Safety and Efficacy of BFH772 in Psoriasis Patients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene

Criteria

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