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NNC 0142-0000-0002

Phase 2

Inflammation | Small molecule | Immunology |Johnson & Johnson|Last Updated: Aug 1, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

NNC 0142-0000-0002 · 1 trial · 2 indications

Phase 2 1
NCT01203631Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's DiseaseInflammation
COMPLETED78 Analytics
PHASE2COMPLETED
Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's Disease
InflammationUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in disease activity assessed by CDAI (Crohn's disease activity index)
From baseline to week 4

Secondary Endpoints

Number of adverse events (AEs)
From baseline to weeks 12 and 24
Immunogenicity of NNC 142-0002
At week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
NNC 0142-0000-0002EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
NNC 0142-0000-0002DRUGA single dose administered subcutaneously (s.c., under the skin)
PlaceboDRUGA single dose administered subcutaneously (s.c., under the skin)
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * Subjects with CD for at least 3 months * Subjects not treated before, or subjects who have either not responded to treatment, or responded and then lost the response during continued administration of a therapeutic compound Exclusion Criteria: * Any of the following: Symptom...

Countries:United StatesBelgiumCanadaFranceHungaryIsraelPolandRussia
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Frequently asked questions about NNC 0142-0000-0002

What is NNC 0142-0000-0002 used for?

NNC 0142-0000-0002 is an investigational small molecule being developed for inflammation, specifically studied in moderately to severely active Crohn's disease. It is in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes NNC 0142-0000-0002?

NNC 0142-0000-0002 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical trials for inflammation and Crohn's disease.

What phase is NNC 0142-0000-0002 in?

NNC 0142-0000-0002 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with moderately to severely active Crohn's disease.

What clinical trials is NNC 0142-0000-0002 in?

NNC 0142-0000-0002 has one completed Phase 2 clinical trial, identified as NCT01203631. This trial evaluated the safety and efficacy of the drug in subjects with moderately to severely active Crohn's disease, enrolling 78 participants across multiple countries including the United States, Belgium, Canada, France, Hungary, Israel, Poland, and Russia.

Is NNC 0142-0000-0002 the same as any other drug?

No alternative names for NNC 0142-0000-0002 have been reported. The drug is identified by this specific code in clinical trial records and is being developed by Johnson & Johnson for inflammation and Crohn's disease.