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

Phase 2

Terminated

• Conditions: Crohn's Disease; Inflammatory Bowel Disease
• Interventions: Drug: AIN457

• Registration Number: NCT01009281
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-30
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Primary Completion: 2010-08-19
• Study Completion: 2010-08-19
• Results First Submitted: 2021-05-13
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-18
• Last Update Submitted: 2021-06-18
• Results First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AIN457	AIN457	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	From Start of the Study up to Study Termination (up to 42 Weeks)

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in C-Reactive Protein Levels	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)
Number of Participants With Anti-AIN457 Antibodies	From Start of the Study up to Study Termination (up to 42 Weeks)	Anti-AIN457 antibodies were assessed in serum.
Change From Baseline in Concentration of Interleukin 17 (IL-17)	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)

Trial Locations

Locations (5)

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, United States

Conneticut Gastroenterology Institute, 39 Brewster Road; 🇺🇸 Bristol, Connecticut, United States

Long Island Clinical Research Associates, LLP; 🇺🇸 Great Neck, New York, United States

UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,; 🇺🇸 Chapel Hill, North Carolina, United States