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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment94

FDA Designations

No designations recorded

Clinical trial landscape

NNC 0151-0000-0000 · 2 trials · 4 indications

Phase 2 1Phase 1 1
NCT01223911A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid ArthritisInflammation
COMPLETED34 Analytics
PHASE2COMPLETED
A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
InflammationUnlock trial analytics

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 to 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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Frequently asked questions about NNC 0151-0000-0000

What is NNC 0151-0000-0000 used for?

NNC 0151-0000-0000 is an investigational small molecule being developed for inflammation. It has been studied in conditions including rheumatoid arthritis and systemic lupus erythematosus. The drug is in Phase 2 clinical development and is not approved for any use.

What does NNC 0151-0000-0000 target?

NNC 0151-0000-0000 is an anti-C5aR antibody, meaning it targets the C5a receptor. This receptor is involved in the complement system, which plays a role in inflammatory responses. By targeting C5aR, the drug aims to modulate inflammation in conditions like rheumatoid arthritis.

Who makes NNC 0151-0000-0000?

NNC 0151-0000-0000 is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in inflammatory conditions.

What phase is NNC 0151-0000-0000 in?

NNC 0151-0000-0000 is in Phase 2 clinical development. It has completed two trials: a Phase 2 trial in rheumatoid arthritis and a Phase 1 dose-escalation trial in healthy subjects. The drug is investigational and has not received FDA approval.

What clinical trials is NNC 0151-0000-0000 in?

NNC 0151-0000-0000 has been studied in two completed trials. NCT01223911 was a Phase 2 multiple dose trial in subjects with rheumatoid arthritis, enrolling 34 participants across several European countries. NCT02151409 was a Phase 1 dose-escalation trial in healthy male subjects, enrolling 60 participants in the Netherlands.

Is NNC 0151-0000-0000 the same as an anti-C5aR antibody?

Yes, NNC 0151-0000-0000 is an anti-C5aR antibody. This is confirmed by the title of its Phase 1 trial, which describes it as an anti-C5aR antibody. The drug targets the C5a receptor to address inflammatory conditions.