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Safety and Efficacy of BFH772 in Psoriasis Patients

Primary Purpose

Psoriasis, Arthritis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BFH772

Placebo

BFH772

Placebo

calcipotriol/betamethasone

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Stable plaque Psoriasis, inflammatory skin, with or without arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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/exclusion criteria may apply

Sites / Locations

Novartis Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Active Comparator

Arm Label

BFH772 cream 1%

Placebo to BFH772 cream 1%

BFH772 ointment 1%

Placebo to BFH772 ointment

calcipotriol/betamethasone ointment

Arm Description

Outcomes

Primary Outcome Measures

Measure: Plaque PASI score

Secondary Outcome Measures

Measure: Local tolerability

Measure: BFH772 concentration in plasma

Measure: BFH772 concentration in skin

Full Information

NCT ID

NCT00987870

First Posted

September 30, 2009

Last Updated

March 25, 2011

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00987870

Brief Title

Safety and Efficacy of BFH772 in Psoriasis Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis, Arthritis

Keywords

Stable plaque Psoriasis, inflammatory skin, with or without arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BFH772 cream 1%

Arm Type

Experimental

Arm Title

Placebo to BFH772 cream 1%

Arm Type

Placebo Comparator

Arm Title

BFH772 ointment 1%

Arm Type

Experimental

Arm Title

Placebo to BFH772 ointment

Arm Type

Placebo Comparator

Arm Title

calcipotriol/betamethasone ointment

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

BFH772

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

BFH772

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

calcipotriol/betamethasone

Primary Outcome Measure Information:

Title

Measure: Plaque PASI score

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Title

Measure: BFH772 concentration in plasma

Time Frame

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

Title

Measure: BFH772 concentration in skin

Time Frame

Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigator Site

City

Berlin

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of BFH772 in Psoriasis Patients

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