Overview

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

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Criteria
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