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NNC109-0012

Phase 2

Inflammation | Small molecule | Immunology |Novo Nordisk A/S|Last Updated: Feb 9, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

NNC109-0012 · 1 trial · 2 indications

Phase 2 1
NCT01282255Efficacy of NNC109-0012 in Subjects With Active Rheumatoid ArthritisInflammation
COMPLETED67 Analytics
PHASE2COMPLETED
Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis
InflammationUnlock trial analytics

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 to 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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Frequently asked questions about NNC109-0012

What is NNC109-0012 used for?

NNC109-0012 is an investigational small molecule being developed for inflammation, specifically studied in active rheumatoid arthritis. It is not approved and remains in clinical development.

Who makes NNC109-0012?

NNC109-0012 is being developed by Novo Nordisk A/S, a biopharmaceutical company traded on the NYSE under the ticker NVO.

What phase is NNC109-0012 in?

NNC109-0012 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is NNC109-0012 in?

NNC109-0012 has one completed Phase 2 trial, NCT01282255, which evaluated its efficacy in subjects with active rheumatoid arthritis. The trial enrolled 67 participants across multiple European countries.

Is NNC109-0012 the same as any other drug?

No alternative names for NNC109-0012 have been identified. It is referred to solely by this identifier in clinical development.