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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00572585
Recruitment Status : Completed
First Posted : December 13, 2007
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):
Novartis ( 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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: AEB071 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AEB071 Drug: AEB071
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00572585

United States, Alabama
Novartis Investigative Site
Mobile, Alabama, United States, 36608
United States, Arizona
Novartis Investigative Site
Mesa, Arizona, United States, 85213
United States, Kansas
Novartis Investigative Site
Topeka, Kansas, United States, 66606
United States, Louisiana
Novartis Investigative Site
Lafayette, Louisiana, United States, 70501
United States, Michigan
Novartis Investigative Site
Chesterfield Twp, Michigan, United States, 48047
Novartis Investigative Site
Troy, Michigan, United States, 48098
United States, Oklahoma
Novartis Investigative Site
Oklahoma City, Oklahoma, United States, 73104
Novartis Investigative Site
Odense C, Denmark, DK-5000
Novartis Investigative Site
Århus, Denmark, DK-8000
Novartis Investigative Site
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
Kraków, Poland, 30-307
Novartis Investigative Site
Poznan, Poland, 60-539
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00572585     History of Changes
Other Study ID Numbers: CAEB071A2210
First Posted: December 13, 2007    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ulcerative colitis
immunosuppressive therapy
Modified Baron score
Partial Mayo score

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases