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

December 15, 2020 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense C, Denmark, DK-5000
        • Novartis Investigative Site
      • Århus, Denmark, DK-8000
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Hamburg, Germany, 22559
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Leipzig, Germany, 04105
        • Novartis Investigative Site
      • Lüneburg, Germany, 21339
        • Novartis Investigative Site
      • Minden, Germany, 32423
        • Novartis Investigative Site
      • Regensburg, Germany, 93053
        • Novartis Investigative Site
      • Stuttgart, Germany, 70376
        • Novartis Investigative Site
  • Poland
      • Kraków, Poland, 30-307
        • Novartis Investigative Site
      • Poznan, Poland, 60-539
        • Novartis Investigative Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Novartis Investigative Site
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Novartis Investigative Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Novartis Investigative Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70501
        • Novartis Investigative Site
    • Michigan
      • Chesterfield Twp, Michigan, United States, 48047
        • Novartis Investigative Site
      • Troy, Michigan, United States, 48098
        • Novartis Investigative Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: AEB071
Drug: AEB071

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Partial Mayo Score throughout entire study, biopsy at end of dosing period
Partial Mayo Score throughout entire study, biopsy at end of dosing period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 15, 2020

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAEB071A2210
  • 2007-002542-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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