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NNC109-0012

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 Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01282255Efficacy of NNC109-0012 in Subjects With Active Rheumatoid ArthritisPHASE2 COMPLETED 67Feb 1, 2011Jan 1, 2012Feb 9, 201729 Czechia, Germany +6
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Study Endpoints
Primary Endpoints
Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value)
week 0, week 12
Secondary Endpoints
Terminal serum half-life (t½)
end of treatment period
Serum levels of NNC109-0012
end of treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NNC109-0012DRUGThe subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
placeboDRUGThe subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Czech Republic: Age between 18 - 65 years (both inclusive) * A diagnosis of RA made at least 3 months prior to trial start * Active RA * Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior t...

Countries:CzechiaGermanyItalyPolandPortugalRomaniaSpainUnited Kingdom
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