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BFH772

Phase 1

Psoriasis | Small molecule | Immunology |Novartis AG|Last Updated: Mar 28, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00987870Safety and Efficacy of BFH772 in Psoriasis PatientsPHASE1 COMPLETED 15Sep 1, 2009 -Mar 28, 20111 Germany
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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 — 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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