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AEB071

Phase 2

Ulcerative Colitis | Small molecule | Immunology |Novartis AG|Last Updated: Dec 22, 2020

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00572585Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative ColitisPHASE2 COMPLETED 60Apr 1, 2010Apr 1, 2012Dec 22, 202020 United States, Denmark +2
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Study Endpoints
Primary Endpoints
Rate of induction of remission after 28 days of treatment (using the Partial Mayo Score and the Modified Baron Score), also an Endoscopic biopsy will be taken
Partial Mayo Score throughout entire study, biopsy at end of dosing period
Secondary Endpoints
Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
Throughout entire study
Measurement of drug concentrations in blood
During the dosing period only
Relationship between drug concentration in blood and disease activity
Dosing period only
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEB071EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AEB071DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * 18-75 years males and females * Female subjects of childbearing potential must be using two methods of contraception * Active, moderate to severe disease * Poor response to or no toleration of conventional therapy (e.g. steroids, mesalamine) * Good communication with the inves...

Countries:United StatesDenmarkGermanyPoland
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