Recent Updates
Recently added Catalysts

NNC0114-0006

Phase 2

Inflammation | Small molecule | Immunology |Novo Nordisk A/S|Last Updated: Mar 31, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials3
Total Enrollment147
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01751152A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy and Safety of NNC0114-0006 in Subjects With Active Crohn's DiseasePHASE2 COMPLETED 53 — — Feb 1, 2013Dec 1, 2014Mar 31, 201728 United States, Bulgaria +4
NCT01647451A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid ArthritisPHASE2 COMPLETED 62 — — Sep 1, 2012Aug 1, 2013Feb 7, 201733 Bulgaria, Hungary +5
NCT01565408Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid ArthritisPHASE1 COMPLETED 32 — — Mar 1, 2012Oct 1, 2013Feb 8, 20175 Germany, Russia
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in Crohn's disease activity index (CDAI)
Week 0, week 4
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Week 0, week 12
Incidence of adverse events (AEs)
From first administration of trial product (week 1) and up until week 27
Secondary Endpoints
Change in CDAI
Week 0, week 12
Clinical remission, defined as CDAI of less than 150
At week 8
Change in the inflammatory bowel disease questionnaire (IBDQ) score
Week 0, week 4
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
NNC0114-0006EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ActiveEXPERIMENTAL -
Interventions
NameTypeDescription
NNC0114-0006DRUGA single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
placeboDRUGA single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Moderately to severely active Crohn's disease, defined as a Crohn's disease activity index (CDAI) of 220-450 (both inclusive) at Visit 2 (Day 0, Dosing), with evidence of inflammation confirmed by a C-reactive protein (CRP) above or equal to 10 mg/L or endoscopic verification ...

Countries:United StatesBulgariaCzechiaPolandSlovakiaSpainHungaryLatviaRussiaSerbiaGermany
Unlock Eligibility Criteria