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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01009281
• Date of registration: 05/11/2009
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
• Scientific 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
• Date of first enrolment: October 2009
• Target sample size: 7
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01009281
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Canada, Germany, Poland, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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 mahor protocol violation in the
core CAIN457A2202 study

- Patients who discontinued from the core CAIN457A2202 study before end of study.

Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Crohn's Disease

Intervention(s)

Drug: AIN457

Primary Outcome(s)

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]

Secondary Outcome(s)

To assess the long term immunogenicity of AIN457 [Time Frame: 60 weeks]

To assess the pharmacokinetics of AIN457 at steady-state [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]

Secondary ID(s)

EudraCT number: 2009-011621-14

CAIN457A2202E1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors