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KRP203 -

Phase 2

Subacute Cutaneous Lupus Erythematosus | Small molecule | Immunology |Novartis AG|Last Updated: Mar 22, 2017

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 Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01294774Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus ErythematosusPHASE2 COMPLETED 10Feb 1, 2011Oct 1, 2012Mar 22, 20178 Germany, Greece +1
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Study Endpoints
Primary Endpoints
Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
12 weeks
Secondary Endpoints
Safety and tolerability of oral KRP203 in patients with subacute cutaneous lupus erythematosus
12 weeks
Steady-state blood concentrations of KRP203 and KRP203-Phosphate (KRP203-P) in SCLE patients
12 weeks
Changes in the activity of SCLE using visual analogue scales for global skin health as assessed by the physician and the patient
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KRP203 - 1.2 mgEXPERIMENTAL -
Placebo to KRP203 - 1.2 mgPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
KRP203 - 1.2mgDRUG -
Placebo to KRP203 - 1.2 mgDRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male and female patients,18 to 65 years of age inclusive, who have been defined as having SCLE based on the typical clinical picture and the characteristic histopathological features as described by Sontheimer et al. at least three months before study entry (screening) Exclus...

Countries:GermanyGreeceItaly
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