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

Novartis

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Placebo; Drug: AEB071

Study type: Interventional

Funder types: Industry

Identifiers

NCT00572585

2007-002542-38

CAEB071A2210

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

AEB071

Experimental group

Treatment:

Drug: AEB071

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo