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

Crohn's Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01009281
• Other study ID #: CAIN457A2202E1
• Secondary ID: EudraCT number:
• Status: Terminated
• Phase: Phase 2
• Start date: October 30, 2009
• Est. completion date: August 19, 2010

Study information

• Verified date: June 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 19, 2010
• Est. primary completion date: August 19, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• AIN457

Locations

Country	Name	City	State
United States	Conneticut Gastroenterology Institute, 39 Brewster Road	Bristol	Connecticut
United States	UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,	Chapel Hill	North Carolina
United States	Long Island Clinical Research Associates, LLP	Great Neck	New York
United States	Mount Sinai, One Gustave L. Levy Place, Box 1118	New York	New York
United States	Wake Research Asspcoates. ::C. 3100 Duraleigh Road, Suite 304	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events		From Start of the Study up to Study Termination (up to 42 Weeks)
Secondary	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)
Secondary	Change From Baseline in Concentration of Interleukin 17 (IL-17)		Baseline up to Study Termination (up to 42 Weeks)
Secondary	Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin		Baseline up to Study Termination (up to 42 Weeks)
Secondary	Change From Baseline in C-Reactive Protein Levels		Baseline up to Study Termination (up to 42 Weeks)
Secondary	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)
Secondary	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)

External Links

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