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An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease

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.
 
ClinicalTrials.gov Identifier: NCT01009281
Recruitment Status : Terminated
First Posted : November 6, 2009
Results First Posted : July 12, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Results First Submitted Date  ICMJE May 13, 2021
Results First Posted Date  ICMJE July 12, 2021
Last Update Posted Date July 12, 2021
Actual Study Start Date  ICMJE October 30, 2009
Actual Primary Completion Date August 19, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
Number of Participants With Adverse Events [ Time Frame: From Start of the Study up to Study Termination (up to 42 Weeks) ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
To assess the long-term safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who participated in the core CAIN457A2202 phase II proof-of-concept study. [ Time Frame: 60 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2021)
  • Number of Participants With Anti-AIN457 Antibodies [ Time Frame: From Start of the Study up to Study Termination (up to 42 Weeks) ]
    Anti-AIN457 antibodies were assessed in serum.
  • Change From Baseline in Concentration of Interleukin 17 (IL-17) [ Time Frame: Baseline up to Study Termination (up to 42 Weeks) ]
  • Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin [ Time Frame: Baseline up to Study Termination (up to 42 Weeks) ]
  • Change From Baseline in C-Reactive Protein Levels [ Time Frame: Baseline up to Study Termination (up to 42 Weeks) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
  • To assess the long term immunogenicity of AIN457 [ Time Frame: 60 weeks ]
  • To assess the long term concentration of IL-17 in blood [ Time Frame: 60 weeks ]
  • To assess markers of disease activity CRP, calprotectin and lactoferrin in the long term [ Time Frame: 60 weeks ]
  • To assess the pharmacokinetics of AIN457 at steady-state [ Time Frame: 60 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Crohn's Disease
  • Inflammatory Bowel Disease
Intervention  ICMJE Drug: AIN457
Study Arms  ICMJE Experimental: AIN457
Intervention: Drug: AIN457
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 6, 2010)
7
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
60
Actual Study Completion Date  ICMJE August 19, 2010
Actual Primary Completion Date August 19, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Austria,   Canada,   Germany,   Poland
 
Administrative Information
NCT Number  ICMJE NCT01009281
Other Study ID Numbers  ICMJE CAIN457A2202E1
EudraCT number: 2009-011621-14
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party External Affairs, Novartis Pharmaceuticals
Current Study Sponsor  ICMJE Novartis Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP