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NIC002

Phase 2

Smokers | Monoclonal antibody | Other |Novartis AG|Last Updated: Mar 21, 2017

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment200
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00736047Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.PHASE2 COMPLETED 200Aug 1, 2008Oct 1, 2009Mar 21, 20172 Germany
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Study Endpoints
Primary Endpoints
Smoking status
12 weeks
Exhaled carbon monoxide
12 weeks
Secondary Endpoints
Smoking status at various time intervals from target quit date to the end of the study
52 weeks
Safety and tolerability
52 weeks
Immunogenicity (specific anti-nicotine antibodies in serum)
52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NIC002BIOLOGICAL -
PlaceboBIOLOGICAL -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Healthy male and female smoking subjects age 18 to 65 years of age * Subjects must be smoking 10 or more cigarettes per day during the past 12 months * The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must b...

Countries:Germany
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