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 - A2202E1

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011621-14-AT

Enrollment

Registered

2009-10-19

Start date

2009-11-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe Crohn's disease (CDAI = 220 and =450) MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

Interventions

Product Name: AIN457 Product Code: AIN457 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Not available CAS Number: None Current Sponsor code: AIN457 Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key inclusion criteria 1. Patients who participate and complete the core CAIN457A2202 study up to at least visit 8 (Day 43) or until 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

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.

Design outcomes

Primary

Measure	Time frame
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 To assess the long term concentration of IL-17 in blood To assess markers of disease activity CRP, calprotectin, lactoferrin in the long term To assess the pharmacokinetics of AIN457 at steady state;Primary end point(s): The long-term safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease will be evaluated at regular intervals throughout the 1 year study period, with a final evaluation for each patient at last visit.	—

Measure

Time frame

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 To assess the long term concentration of IL-17 in blood To assess markers of disease activity CRP, calprotectin, lactoferrin in the long term To assess the pharmacokinetics of AIN457 at steady state;Primary end point(s): The long-term safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease will be evaluated at regular intervals throughout the 1 year study period, with a final evaluation for each patient at last visit.

—

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026