This study will evaluate the efficacy, safety and tolerability of AEB071 in the treatment of active, moderate to severe ulcerative colitis in patients who have failed conventional therapy using mesalamine or steroids
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Novartis Investigative Site
Mobile, Alabama, United States
Novartis Investigative Site
Mesa, Arizona, United States
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
Time frame: Partial Mayo Score throughout entire study, biopsy at end of dosing period
Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
Time frame: Throughout entire study
Measurement of drug concentrations in blood
Time frame: During the dosing period only
Relationship between drug concentration in blood and disease activity
Time frame: Dosing period only
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Novartis Investigative Site
Topeka, Kansas, United States
Novartis Investigative Site
Lafayette, Louisiana, United States
Novartis Investigative Site
Chesterfield Twp, Michigan, United States
Novartis Investigative Site
Troy, Michigan, United States
Novartis Investigative Site
Oklahoma City, Oklahoma, United States
Novartis Investigative Site
Aarhus, Denmark
Novartis Investigative Site
Odense C, Denmark
Novartis Investigative Site
Berlin, Germany
...and 10 more locations