Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: AEB071
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 investigator, understanding and compliance with the requirements of the study and written informed consent Exclusion Criteria: Allergy to the drug Very low or high body weight Ongoing treatment with specific other medication (e.g. antibiotics) Diagnosis of primary sclerosing cholangitis Renal impairment Toxic megacolon Presence or history of specific other diseases, cancer, cardiac abnormalities, abnormal laboratory findings History of alcohol or drug abuse Pregnant or breastfeeding women Positive HIV, Hepatitis B or Hepatitis C test result Other protocol-defined inclusion/exclusion criteria do apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AEB071<br> | Drug: AEB071<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score