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BFH772

Phase 1

Psoriasis | Small molecule | Dermatology |Novartis AG|Trials Updated: Mar 28, 2011

BFH772 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2009

BFH772 target and mechanism

Molecular targetKDR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

BFH772 clinical trials

BFH772 · 1 trial · 2 indications

Phase 1 1
NCT00987870Safety and Efficacy of BFH772 in Psoriasis PatientsPsoriasis
COMPLETED15 Analytics
PHASE1COMPLETED
Safety and Efficacy of BFH772 in Psoriasis Patients
PsoriasisUnlock trial analytics

Study Endpoints

Primary Endpoints

Measure: Plaque PASI score
4 weeks

Secondary Endpoints

Measure: Local tolerability
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
Measure: BFH772 concentration in plasma
Day 1: Pre-dose; 4h post dose.
Measure: BFH772 concentration in skin
Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BFH772 cream 1%EXPERIMENTAL -
Placebo to BFH772 cream 1%PLACEBO_COMPARATOR -
BFH772 ointment 1%EXPERIMENTAL -
Placebo to BFH772 ointmentPLACEBO_COMPARATOR -
calcipotriol/betamethasone ointmentACTIVE_COMPARATOR -

Interventions

NameTypeDescription
BFH772DRUG -
PlaceboDRUG -
calcipotriol/betamethasoneDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 arthri...

Countries:Germany
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Frequently asked questions about BFH772

What is BFH772 used for?

BFH772 is an investigational small molecule developed by Novartis for the treatment of psoriasis. It has been studied in a Phase 1 clinical trial in patients with psoriasis and arthritis. It is not approved for any indication and remains in clinical development.

What does BFH772 target?

BFH772 targets KDR, also known as vascular endothelial growth factor receptor 2 (VEGFR2). It acts as an inhibitor of this receptor kinase. KDR inhibition is the proposed mechanism by which BFH772 is intended to affect psoriasis.

Who is developing BFH772?

BFH772 is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating BFH772 in dermatology, specifically for psoriasis.

What phase is BFH772 in?

BFH772 is in Phase 1 clinical development. The program has completed one Phase 1 trial and has no active trials. BFH772 is investigational and has not been approved by the FDA or any other regulatory authority for psoriasis or any other indication.

What clinical trials is BFH772 in?

BFH772 has been evaluated in one completed Phase 1 trial, NCT00987870, titled Safety and Efficacy of BFH772 in Psoriasis Patients. The trial enrolled 15 adults in Germany and studied patients with psoriasis and arthritis. It was randomized, double-blind, and placebo-controlled.