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’sdisease - n/a

• Conditions: Moderate to severe Crohn's disease (CDAI = 220 and =450); MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2009-011621-14-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Key inclusion criteria

1. 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.

Full inclusion criteria are presented in sections 5.2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria

1. Patients for whom continued treatment with AIN457 is not considered appropriate by the treating physician.
2. Patients who were non-compliant or who demonstrated a major protocol violation in the core CAIN457A2202 study.
3. Patients who discontinued from the core CAIN457A2202 study before end of study.

Full exclusion criteria are presented in section 5.3.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To assess the long term immunogenicity of AIN457<br>To assess the long term concentration of IL-17 in blood<br>To assess markers of disease activity CRP, calprotectin, lactoferrin in the long term<br>To assess the pharmacokinetics of AIN457 at steady state;Primary end point(s): Efficacy will be evaluated using the Crohn's Disease Activity Index (CDAI).