Back to resultsEfficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AEB071
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score
Eligibility 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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AEB071
Placebo
Arm Description
Outcomes
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
Secondary Outcome Measures
Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
Measurement of drug concentrations in blood
Relationship between drug concentration in blood and disease activity
Full Information
NCT ID
NCT00572585
First Posted
December 12, 2007
Last Updated
December 15, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00572585
Brief Title
Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
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 Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative colitis, immunosuppressive therapy, AEB071, Modified Baron score, Partial Mayo score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AEB071
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AEB071
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety and tolerability assessments (vital signs, electrocardiogram [ECG], blood samples, serious adverse events, adverse events)
Time Frame
Throughout entire study
Title
Measurement of drug concentrations in blood
Time Frame
During the dosing period only
Title
Relationship between drug concentration in blood and disease activity
Time Frame
Dosing period only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Novartis Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Novartis Investigative Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Novartis Investigative Site
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70501
Country
United States
Facility Name
Novartis Investigative Site
City
Chesterfield Twp
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Novartis Investigative Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novartis Investigative Site
City
Odense C
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Århus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04105
Country
Germany
Facility Name
Novartis Investigative Site
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Novartis Investigative Site
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Novartis Investigative Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigative Site
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Novartis Investigative Site
City
Kraków
ZIP/Postal Code
30-307
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-539
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8363
Description
Results for CAEB071A2210 from the Novartis Clinical Trials website
Learn more about this trial
Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis
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