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NNC 0142-0000-0002

Phase 2

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

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_CONTROLLED
Total Trials1
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01203631Safety and Efficacy of NNC 0142-0000-0002 in Subjects With Moderately to Severely Active Crohn's DiseasePHASE2 COMPLETED 78Feb 1, 2011May 1, 2013Aug 1, 201623 United States, Belgium +6
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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 — 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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