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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2009-011621-14-AT
• Date of registration: 19/10/2009
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public 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 - A2202E1
• 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 - A2202E1
• Date of first enrolment: 12/11/2009
• Target sample size: 72
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011621-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Austria, Germany

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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: None
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

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.

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

Secondary ID(s)

not available

CAIN457A2202E1