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683699

Phase 2

Crohn's Disease | Small molecule | Immunology |GSK plc|Last Updated: Apr 13, 2015

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 Trials1
Total Enrollment17
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00101946Nine-Weeks Treatment With 683699 In Subjects With Moderately-To-Severely Active Crohn's DiseasePHASE2 COMPLETED 17Oct 1, 2004Jul 1, 2006Apr 13, 201519 United States, Canada
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Study Endpoints
Primary Endpoints
Proportion of subjects who are responders at Week 6.
Secondary Endpoints
- Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in Quality of Life.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
683699DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion criteria: * Diagnosed with CD and reconfirmed in previous 2 years by a radiologic or endoscopic assessment including histology. * CDAI (Crohn's Disease Activity Index) score of 220-450 after 1 week of screening. * CRP (C-Reactive Protein) level of \>4mg at screening. Exclusion criteria: ...

Countries:United StatesCanada
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