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6MP or Calcitriol vs. Purinethol

Phase 1

Crohn's Disease | Small molecule | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Jul 8, 2008

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00287170Efficacy Study of Targeted, Local Delivery of Drugs to Treat Crohn's DiseasePHASE1 COMPLETED 15Jul 1, 2006Dec 1, 2007Jul 8, 20081 Israel
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Study Endpoints
Primary Endpoints
Remission-defined as a CDAI (Crohn's Disease Activity Index) of <150
12 weeks
Response- defined as a fall in the CDAI by 100 points or more from baseline
12 weeks
Secondary Endpoints
Improvement in ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein) levels, and IBDQ (Inflammatory Bowel Disease Questionnaire) >=180 indicative of remission
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Delayed Release 6MP or Calcitriol vs. PurinetholDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or Female patients, aged 18-75 years with moderate Crohn's Disease (CDAI score \>=220 and \<=400 at screening), with or without adjunctive mesalamine treatment, 12 with involvement of the ileum and three without ileal involvement * Definitive diagnosis of active inflammat...

Countries:Israel
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