Safety and Efficacy of BFH772 in Psoriasis Patients

Phase 1

Completed

• Conditions: Psoriasis; Arthritis
• Interventions: Drug: BFH772; Drug: Placebo; Drug: calcipotriol/betamethasone

• 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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Primary Completion: 2010-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-25
• Last Update Posted: 2011-03-28

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