Safety and Efficacy of BFH772 in Psoriasis Patients

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psoriasis; Arthritis

Treatments: Drug: BFH772; Drug: calcipotriol/betamethasone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00987870

CBFH772A2201

EUDRACT No. 2008-002795-96

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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15 participants in 5 patient groups, including a placebo group

BFH772 cream 1%

Experimental group

Treatment:

Drug: BFH772

Drug: BFH772

Placebo to BFH772 cream 1%

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

BFH772 ointment 1%

Experimental group

Treatment:

Drug: BFH772

Drug: BFH772

Placebo to BFH772 ointment

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

calcipotriol/betamethasone ointment

Active Comparator group

Treatment:

Drug: calcipotriol/betamethasone