Safety and Efficacy of BFH772 in Psoriasis Patients

Phase 2CompletedNCT00987870

Novartis Pharmaceuticals15 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Psoriasis Arthritis

Interventions

BFH772DRUG

PlaceboDRUG

BFH772DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novartis Investigator Site

Berlin, Germany

Outcomes

Primary Outcomes

Measure: Plaque PASI score

Time frame: 4 weeks

Secondary Outcomes

Measure: Local tolerability

Time frame: 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

Time frame: Day 1: Pre-dose; 4h post dose.

Measure: BFH772 concentration in skin

Time frame: Week 4

Data from ClinicalTrials.gov

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