Safety and Efficacy of BFH772 in Psoriasis Patients

Psoriasis Clinical Trial

Official title:

A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987870
• Other study ID #: CBFH772A2201
• Secondary ID: EUDRACT No. 2008
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 30, 2009
• Last updated: March 25, 2011
• Start date: September 2009

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Psoriasis

Intervention

Drug:
• BFH772

• Placebo

• BFH772

• Placebo

• calcipotriol/betamethasone

Locations

Country	Name	City	State
Germany	Novartis Investigator Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: Plaque PASI score		4 weeks	No
Secondary	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	Yes
Secondary	Measure: BFH772 concentration in plasma		Day 1: Pre-dose; 4h post dose.	Yes
Secondary	Measure: BFH772 concentration in skin		Week 4	Yes