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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Crohn's Disease, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: AIN457


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIN457<br> | Drug: AIN457<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 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 | 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) |  | Baseline up to Study Termination (up to 42 Weeks) | 
| Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin |  | Baseline up to Study Termination (up to 42 Weeks) | 
| Change From Baseline in C-Reactive Protein Levels |  | 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) |  | 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) |  | Pre-dose, post dose on week 44 (end of infusion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)