Safety and Efficacy of BFH772 in Psoriasis Patients

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00987870

Enrollment

Registered

2009-10-01

Start date

2009-09-30

Completion date

Unknown

Last updated

2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriasis

Keywords

Stable plaque Psoriasis, inflammatory skin, with or without arthritis

Brief summary

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

Interventions

DRUGBFH772

DRUGPlacebo

DRUGcalcipotriol/betamethasone

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Measure: Plaque PASI score	4 weeks

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026