Skip to main content
OpenTrials
Completed

NCT Number: NCT00572585

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AEB071

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)

    Time frame: Throughout entire study

  2. Measurement of drug concentrations in blood

    Time frame: During the dosing period only

  3. Relationship between drug concentration in blood and disease activity

    Time frame: Dosing period only

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2007
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.