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

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Placebo; Drug: AEB071

• Registration Number: NCT00572585
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Study First Posted: 2007-12-13
• Study Start: 2010-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2017-03
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
AEB071	AEB071	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Measurement of drug concentrations in blood	During the dosing period only
Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)	Throughout entire study
Relationship between drug concentration in blood and disease activity	Dosing period only

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇱 Poznan, Poland