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

June 18, 2021 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Conneticut Gastroenterology Institute, 39 Brewster Road
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
      • New York, New York, United States, 10029
        • Mount Sinai, One Gustave L. Levy Place, Box 1118
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7032
        • UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AIN457
Drug: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events
Time Frame: From Start of the Study up to Study Termination (up to 42 Weeks)
From Start of the Study up to Study Termination (up to 42 Weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Start of the Study up to Study Termination (up to 42 Weeks)
Change From Baseline in Concentration of Interleukin 17 (IL-17)
Time Frame: Baseline up to Study Termination (up to 42 Weeks)
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)
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)
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)
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)
Pre-dose, post dose on week 44 (end of infusion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2009

Primary Completion (ACTUAL)

August 19, 2010

Study Completion (ACTUAL)

August 19, 2010

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (ESTIMATE)

November 6, 2009

Study Record Updates

Last Update Posted (ACTUAL)

July 12, 2021

Last Update Submitted That Met QC Criteria

June 18, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457A2202E1
  • EudraCT number: 2009-011621-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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