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

This study has been terminated.
(The proof of concept (PoC) studies for uveitis and ulcerative colitis did not meet PoC criteria for demonstrating adequate efficacy to move forward)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00572585
First received: December 12, 2007
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Ulcerative Colitis
 Drug: AEB071
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events) [ Time Frame: Throughout entire study ] [ Designated as safety issue: Yes ]
  • Measurement of drug concentrations in blood [ Time Frame: During the dosing period only ] [ Designated as safety issue: No ]
  • Relationship between drug concentration in blood and disease activity [ Time Frame: Dosing period only ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AEB071 Drug: AEB071
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572585

Locations
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
Denmark
Novartis Investigative Site
Odense C, Denmark, DK-5000
Novartis Investigative Site
Århus, Denmark, DK-8000
Germany
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
Poland
Novartis Investigative Site
Kraków, Poland, 30-307
Novartis Investigative Site
Poznan, Poland, 60-539
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00572585     History of Changes
Other Study ID Numbers: CAEB071A2210, 2007-002542-38
Study First Received: December 12, 2007
Last Updated: February 12, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Denmark: Danish Medicines Agency

Keywords provided by Novartis:
Ulcerative colitis
immunosuppressive therapy
AEB071
Modified Baron score
Partial Mayo score

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

ClinicalTrials.gov processed this record on May 23, 2013