Trial Information

A Phase 2, Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 888 Administered Intravenously in Subjects With Idiopathic Pulmonary Fibrosis

This study tests the safety and effectiveness of an experimental drug, CNTO 888, compared to
placebo. The purpose of this research study is to determine if CNTO 888 is safe and to
determine its effects on patients with idiopathic pulmonary fibrosis (IPF). CNTO 888 has not
been approved by any regulatory authority for use in patients with any condition. The
screening phase of the study, where the study doctor will determine if a patient is eligible
for the study will last for 1 to 4 weeks. The study will enroll and treat the first 20
patients as part of a safety evaluation, at selected sites. The patients will be randomized
to placebo or 1 mg/kg or 5 mg/kg or 15 mg/kg CNTO 888. The study drug will be given through
a needle inserted into the patient's vein (IV). A Data Monitoring Committee will be
responsible to review this portion of the study, and the study in general. They will review
all of the information from patients in this portion of the study, after patients have
received three infusions of study agent, or 3 months have passed since the first patient was
enrolled. After their review, they will recommend whether to continue enrolling additional
patients for the remainder of the study, or require some modification to the study. Patients
will receive study agent until Week 48 and will continue to be followed through Week 72 for
assessment of safety and any other effects after discontinuation of therapy. Patients will
be in the study for about 74 weeks. The end of the study is defined as the last visit of the
last patient. Patients will be randomly assigned to 1 of 4 treatment groups. Group 1,
placebo IV infusion administered over 90 minutes every 4 weeks, from Week 0 through Week 48.
Group 2, CNTO 888 1 mg/kg IV infusion administered over 90 minutes every 4 weeks, from Week
0 through Week 48. Group 3, CNTO 888 5 mg/kg IV infusion administered over 90 minutes every
4 weeks, from Week 0 through Week 48. Group 4, CNTO 888 15 mg/kg IV infusion administered
over 90 minutes every 4 weeks, from Week 0 through Week 48. Enrollment completed as planned.
Dosing terminated after interim DMC (Data Monitoring Committee) review. Subjects followed
until trial completed.