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Anti-IP-10 Antibody

Phase 2

Colitis, Ulcerative | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jun 25, 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-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment305
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01294410Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative ColitisPHASE2 COMPLETED 305 — — Mar 1, 2011Dec 1, 2014Jun 25, 201575 United States, Australia +12
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Study Endpoints
Primary Endpoints
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo
End of Induction [Week 11, Induction Period-78 (IP-78)]
Secondary Endpoints
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo
IP-78 (Week 11)
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo
IP-78 (Week 11)
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values
IP-78 (Week 11)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: InductionEXPERIMENTALPlacebo or Anti-IP-10 Antibody
Cohort 2: InductionEXPERIMENTALPlacebo or Anti-IP-10 Antibody
Cohort 3: InductionEXPERIMENTALPlacebo or Anti-IP-10 Antibody
MaintenanceEXPERIMENTALPlacebo or Anti-IP-10 Antibody
Open LabelOTHER -
Interventions
NameTypeDescription
PlaceboDRUGNormal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
Anti-IP-10 AntibodyDRUGSolution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites75

Inclusion Criteria: * Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence * Mayo score ≥6 with an endoscopic subscore of ≥2 * Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticost...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaFranceGermanyHungaryItalyMexicoNetherlandsPolandSouth Africa
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