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NNC 0151-0000-0000

Phase 2

Inflammation | Small molecule | Immunology |Novo Nordisk A/S|Last Updated: Feb 9, 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 Trials2
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01223911A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid ArthritisPHASE2 COMPLETED 34Jan 1, 2011Feb 1, 2013Feb 9, 201716 Czechia, Denmark +4
NCT02151409Dose-escalation Trial of Anti-C5aR Antibody in Healthy SubjectsPHASE1 COMPLETED 60Jun 1, 2008Oct 1, 2009Feb 9, 20171 Netherlands
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Study Endpoints
Primary Endpoints
Number of adverse events (AEs)
at all scheduled visits (week 1 - week 11)
Adverse events (AEs)
Week 0-10
Secondary Endpoints
Serum concentrations of NNC 151-0000-0000
at 48 hours after all dose administrations
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -
NNC 0151-0000-0000 i.v.EXPERIMENTALDose escalation trial
NNC 0151-0000-0000 s.c.EXPERIMENTALDose escalation trial
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NNC 0151-0000-0000DRUGMultiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
placeboDRUGMultiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * CZ: Age between 18 and 65 years (both inclusive) * A diagnosis of rheumatoid arthritis of at least three months before entry in trial * Active rheumatoid arthritis (RA) * Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before ...

Countries:CzechiaDenmarkHungaryPolandRomaniaUnited KingdomNetherlands
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