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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00572585
• Date of registration: 12/12/2007
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
• Scientific title: 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
• Date of first enrolment: April 2010
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00572585
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Denmark, Germany, Poland, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: AEB071

Drug: Placebo

Primary Outcome(s)

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]

Secondary Outcome(s)

Relationship between drug concentration in blood and disease activity [Time Frame: Dosing period only]

Measurement of drug concentrations in blood [Time Frame: During the dosing period only]

Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) [Time Frame: Throughout entire study]

Secondary ID(s)

2007-002542-38

CAEB071A2210

Source(s) of Monetary Support

Please refer to primary and secondary sponsors