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QAX576

Phase 2

Crohn's Disease | Small molecule | Immunology |Novartis AG|Last Updated: Feb 23, 2017

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01355614A Phase II Efficacy Study in Fistulizing Crohn's Disease PatientsPHASE2 COMPLETED 10Jun 1, 2011Mar 1, 2013Feb 23, 20176 Germany, Switzerland
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Study Endpoints
Primary Endpoints
Assessment of efficacy of QAX576 to induce complete closure for at least 4 weeks of all perianal fistulas in patients suffering from Crohn's disease by: clinical observation and cutaneous photodocumentation
52 weeks
Secondary Endpoints
Assessment of safety and tolerability of QAX576 in patients suffering from Crohn's disease as measured by lab assessments, ECG, physical exam etc
52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
QAX576EXPERIMENTAL -
InfliximabOTHER -
Interventions
NameTypeDescription
QAX576DRUG -
InfliximabDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * At least one draining enterocutaneous perianal fistula * Diagnosis of Crohn's disease (CD) must have been established for at least 6 months * At least one ineffective fistula treatment (but no previously failed anti-TNFα (tumour necrosis factor) antibody treatment) * Patients ...

Countries:GermanySwitzerland
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