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CDP323

Phase 1

Relapsing Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Sep 12, 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_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00726648CDP323 Biomarker StudyPHASE1 COMPLETED 71Jul 1, 2008Mar 1, 2009Sep 12, 20112 United Kingdom
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Study Endpoints
Primary Endpoints
Pharmacodynamic parameters related to leukocyte trafficking
4 weeks
Secondary Endpoints
Standard and disease-related safety variables
4 weeks
Class-related safety parameters
4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3EXPERIMENTAL -
4EXPERIMENTAL -
5PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
CDP323DRUG50mg capsules, 100mg bid for 4 weeks
PlaceboDRUGplacebo capsules for 4 weeks
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Female and male subjects aged 18-65 years * Relapsing form of MS with at least one clinical relapse in the 24 months before screening; * Screening EDSS score of 0-6.5; * Must be fully immunocompetent * Female subjects of childbearing potential must agree to practice contracept...

Countries:United Kingdom
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