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Pegylated interferon lambda

Phase 3

Hepatitis C Virus (HCV) | Monoclonal antibody | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Oct 9, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment880
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01616524Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3PHASE3 COMPLETED 880 — — Jul 1, 2012Sep 1, 2014Oct 9, 2015124 United States, Argentina +17
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Study Endpoints
Primary Endpoints
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
Post-treatment follow-up week 12
Secondary Endpoints
Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
On-treatment Week 4
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
Up to week 12 or week 24
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
Up to week 12 or week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1: pegIFNλ + Ribavirin + Placebo matching DaclatasvirEXPERIMENTAL -
Arm 2: pegIFNλ + Ribavirin + DaclatasvirEXPERIMENTAL -
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching DaclatasvirEXPERIMENTAL -
Interventions
NameTypeDescription
Pegylated interferon lambda (pegIFNλ)BIOLOGICALSyringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Pegylated interferon alfa-2a (pegIFNα-2a)BIOLOGICALSyringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
RibavirinDRUGTablets, Oral, 400 mg, Twice daily, 24 weeks
DaclatasvirDRUGTablets, Oral, 60 mg, Once daily, 12 weeks
Placebo matching DaclatasvirDRUGTablets, Oral, 0 mg, Once daily, 12 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites124

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Chronic hepatitis C, Genotype 2 or 3 * Naïve to prior anti-HCV therapy Exclusion Criteria: * Infected with HCV other than Genotype 2 or 3 * Positive Hepatitis B surface ant...

Countries:United StatesArgentinaAustraliaBelgiumChileFinlandFranceGreeceHong KongItalyJapanMexicoNetherlandsNew ZealandRussiaSingaporeSouth KoreaTaiwanUnited Kingdom
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