Back to resultsAn Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Primary Purpose
Crohn's Disease, Inflammatory Bowel Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AIN457
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Crohns, Bowel disease, digestive disorders, auto immune, diarrhea, Inflammatory Bowel Disease (IBD), gastrointestinal diseases, digestive system diseases, Antibody, IL 17, anti IL-17, monoclonal antibody, Crohn's Disease (Chron's, CD)
Eligibility Criteria
Inclusion Criteria:
- Patients who participate and complete the core CAIN457A2202 study up to and including Visit 11 (end of study), may enter the extension study upon signing informed consent.
Exclusion Criteria:
- Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
- Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study
- Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Conneticut Gastroenterology Institute, 39 Brewster Road
- Long Island Clinical Research Associates, LLP
- Mount Sinai, One Gustave L. Levy Place, Box 1118
- UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
- Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AIN457
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Number of Participants With Anti-AIN457 Antibodies
Anti-AIN457 antibodies were assessed in serum.
Change From Baseline in Concentration of Interleukin 17 (IL-17)
Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
Change From Baseline in C-Reactive Protein Levels
Maximum (Peak) Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids During Multiple Dosing [Amount x Volume-1] (Cmax,ss)
Minimum Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids at the End of the Dosing Intervals During Multiple Dosing [Amount x Volume-1] (Cmin,ss)
Full Information
NCT ID
NCT01009281
First Posted
November 5, 2009
Last Updated
June 18, 2021
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01009281
Brief Title
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Official Title
A 52 Week Open Label Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti IL-17 Monoclonal Antibody) in Patients With Moderate to Severe Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Study Start Date
October 30, 2009 (Actual)
Primary Completion Date
August 19, 2010 (Actual)
Study Completion Date
August 19, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Inflammatory Bowel Disease
Keywords
Crohn's Disease, Crohns, Bowel disease, digestive disorders, auto immune, diarrhea, Inflammatory Bowel Disease (IBD), gastrointestinal diseases, digestive system diseases, Antibody, IL 17, anti IL-17, monoclonal antibody, Crohn's Disease (Chron's, CD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIN457
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AIN457
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
From Start of the Study up to Study Termination (up to 42 Weeks)
Secondary Outcome Measure Information:
Title
Number of Participants With Anti-AIN457 Antibodies
Description
Anti-AIN457 antibodies were assessed in serum.
Time Frame
From Start of the Study up to Study Termination (up to 42 Weeks)
Title
Change From Baseline in Concentration of Interleukin 17 (IL-17)
Time Frame
Baseline up to Study Termination (up to 42 Weeks)
Title
Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin
Time Frame
Baseline up to Study Termination (up to 42 Weeks)
Title
Change From Baseline in C-Reactive Protein Levels
Time Frame
Baseline up to Study Termination (up to 42 Weeks)
Title
Maximum (Peak) Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids During Multiple Dosing [Amount x Volume-1] (Cmax,ss)
Time Frame
Pre-dose, post dose on week 44 (end of infusion)
Title
Minimum Observed Steady-State Drug Concentration in the Plasma, Blood, Serum, or Other Body Fluids at the End of the Dosing Intervals During Multiple Dosing [Amount x Volume-1] (Cmin,ss)
Time Frame
Pre-dose, post dose on week 44 (end of infusion)
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:
Patients who participate and complete the core CAIN457A2202 study up to and including Visit 11 (end of study), may enter the extension study upon signing informed consent.
Exclusion Criteria:
Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study
Patients who discontinued from the core CAIN457A2202 study before Visit 8 (day 43).
Other protocol-defined inclusion/exclusion criteria may 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
Conneticut Gastroenterology Institute, 39 Brewster Road
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Mount Sinai, One Gustave L. Levy Place, Box 1118
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7032
Country
United States
Facility Name
Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22595313
Citation
Hueber W, Sands BE, Lewitzky S, Vandemeulebroecke M, Reinisch W, Higgins PD, Wehkamp J, Feagan BG, Yao MD, Karczewski M, Karczewski J, Pezous N, Bek S, Bruin G, Mellgard B, Berger C, Londei M, Bertolino AP, Tougas G, Travis SP; Secukinumab in Crohn's Disease Study Group. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut. 2012 Dec;61(12):1693-700. doi: 10.1136/gutjnl-2011-301668. Epub 2012 May 17.
Results Reference
derived
Links:
URL
http://www.NovartisClinicalTrials.com
Description
Related Info
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An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
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