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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014