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

Phase 2TerminatedNCT01009281

Novartis Pharmaceuticals7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease Inflammatory Bowel Disease

Interventions

AIN457DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

Conneticut Gastroenterology Institute, 39 Brewster Road

Bristol, Connecticut, 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

UNC School of Medicine, Room 7200 MBRB, 103 Mason Farm Road,

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

Time frame: From Start of the Study up to Study Termination (up to 42 Weeks)

Secondary Outcomes

Number of Participants With Anti-AIN457 Antibodies

Anti-AIN457 antibodies were assessed in serum.

Time frame: From Start of the Study up to Study Termination (up to 42 Weeks)

Change From Baseline in Concentration of Interleukin 17 (IL-17)

Time frame: Baseline up to Study Termination (up to 42 Weeks)

Change From Baseline in Levels of Fecal Calprotectin and Lactoferrin

Time frame: Baseline up to Study Termination (up to 42 Weeks)

Change From Baseline in C-Reactive Protein Levels

Time frame: 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)

Time frame: 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)

Time frame: Pre-dose, post dose on week 44 (end of infusion)

Data from ClinicalTrials.gov

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