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Safety and Efficacy of BFH772 in Psoriasis Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00987870
First received: September 30, 2009
Last updated: March 25, 2011
Last verified: March 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Psoriasis
Arthritis
 Drug: BFH772
Drug: Placebo
Drug: calcipotriol/betamethasone
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof of Concept Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Topical Administrations of BFH772 in Patients With Psoriasis.

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Plaque PASI score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Measure: BFH772 concentration in plasma [ Time Frame: Day 1: Pre-dose; 4h post dose. ] [ Designated as safety issue: Yes ]
  • Measure: BFH772 concentration in skin [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: September 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BFH772 cream 1% Drug: BFH772
Placebo Comparator: Placebo to BFH772 cream 1% Drug: Placebo
Experimental: BFH772 ointment 1% Drug: BFH772
Placebo Comparator: Placebo to BFH772 ointment Drug: Placebo
Active Comparator: calcipotriol/betamethasone ointment Drug: calcipotriol/betamethasone

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987870

Locations
Germany
Novartis Investigator Site
Berlin, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00987870     History of Changes
Other Study ID Numbers: CBFH772A2201, EUDRACT No. 2008-002795-96
Study First Received: September 30, 2009
Last Updated: March 25, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Stable plaque Psoriasis
inflammatory skin
with or without arthritis

Additional relevant MeSH terms:
Arthritis
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Calcipotriene
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013