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Completed

NCT Number: NCT00987870

Safety and Efficacy of BFH772 in Psoriasis Patients

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

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Key information

Conditions

Psoriasis Arthritis Joint Diseases Musculoskeletal Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigator Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BFH772

Drug

Placebo

Drug

calcipotriol/betamethasone

Drug

Primary outcomes

  1. Measure: Plaque PASI score

    Time frame: 4 weeks

Secondary outcomes

  1. 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

  2. Measure: BFH772 concentration in plasma

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

  3. Measure: BFH772 concentration in skin

    Time frame: Week 4

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
First posted
Oct 1, 2009
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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