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BCT194

Phase 1

Psoriasis | Small molecule | Immunology |Novartis AG|Last Updated: Feb 28, 2012

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-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01539915Pharmacokinetics and Pharmacodynamics of BCT194 in Psoriatic PatientsPHASE1 COMPLETED 12Apr 1, 2007 -Feb 28, 20121 Austria
NCT00417820Study of the Safety, Tolerability and Efficacy of BCT194 in Healthy Volunteers and Patients With Psoriasis.PHASE1 COMPLETED 35Nov 1, 2006Nov 1, 2007Nov 29, 20071 Austria
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Study Endpoints
Primary Endpoints
change in Maximum dermal interstitial concentration of BCT194
Day 1 and day 8

Interstitial fluid will be collected and concentrations of BCT194 determined determined on Day 1 and Day 8 at several timepoints

Area under the curve interstitial concentrations of BCT194
day 1 and day 8

Interstitial fluid will be collected and concentrations of BCT194 determined on Day 1 and Day 8 at several timepoints

Safety & tolerability
Efficacy as assessed by plaque Psoriasis Area and Severity Index (PASI) scoring at 4 weeks
Secondary Endpoints
Concentrations of locally produced tumor necrosis factor-alpha (TNF-alpha)
day 1 and day 8
Change in plaque PASI scores of psoriasis lesions
day 1 and day 8
BCT194 concentrations in skin biopsies
day 1 and day 8
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Study Design & Arms
AllocationNA
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
BCT194EXPERIMENTAL -
Interventions
NameTypeDescription
BCT194DRUGTopically applied BCT194 cream (0.5%)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Male patients and post menopausal or surgically sterile female patients aged 18 - 75 years. * Diagnosis of stable plaque psoriasis (with or without arthritis); diagnosed or history of psoriasis for at least 6 months prior to screening * Psoriatic plaques accessible for micrope...

Countries:Austria
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