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Anti-IP-10 Antibody

Phase 2

Colitis, Ulcerative | Small molecule | Gastrointestinal |Bristol-Myers Squibb Company|Last Updated: Jun 25, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment305

FDA Designations

No designations recorded

Clinical trial landscape

Anti-IP-10 Antibody · 1 trial · 1 indication

Phase 2 1
NCT01294410Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative ColitisColitis, Ulcerative
COMPLETED305 Analytics
PHASE2COMPLETED
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
Colitis, UlcerativeUnlock trial analytics

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 to 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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Frequently asked questions about Anti-IP-10 Antibody

What is Anti-IP-10 Antibody used for?

Anti-IP-10 Antibody is an investigational drug being studied for the treatment of moderate to severe ulcerative colitis, a form of inflammatory bowel disease. It is being developed by Bristol-Myers Squibb Company (BMY) and has completed a Phase 2 clinical trial.

Who makes Anti-IP-10 Antibody?

Anti-IP-10 Antibody is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company conducted a Phase 2 clinical trial of the drug in patients with moderate to severe ulcerative colitis.

What phase is Anti-IP-10 Antibody in?

Anti-IP-10 Antibody is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 trial for ulcerative colitis has been completed.

What clinical trials is Anti-IP-10 Antibody in?

Anti-IP-10 Antibody has one completed clinical trial, NCT01294410, titled 'Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis.' This Phase 2 trial enrolled 305 participants across multiple countries including the United States, Australia, and European nations.

Is Anti-IP-10 Antibody the same as BMS-936557?

Yes, Anti-IP-10 Antibody is also known as BMS-936557. The clinical trial NCT01294410, which studied the drug in ulcerative colitis, refers to it as BMS-936557 in its official title.