A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The experimental drug CNTO 888 is currently being studied in cancer patients with solid
      tumors and this study is the first to use this drug for patients with idiopathic pulmonary
      fibrosis (IPF). This study tests the safety and effectiveness of CNTO 888 compared to
      placebo. The purpose of this research study is to determine if CNTO 888 is safe and to
      determine its effects (good and bad) on patients with IPF. The study will be conducted at
      approximately 28 sites globally. Patients can remain on usual, accepted treatment for IPF
      while enrolled in the study. Participating in other experimental studies or taking other
      experimental medications while participating in this study will not be allowed.
    

Detailed description: 
      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. Participants followed until trial completed.
    

Intervention name(s): Placebo; CNTO 888 1 mg/kg; CNTO 888 5 mg/kg; CNTO 888 15 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48; IV infusion every 4 weeks, from Week 0 through Week 48; IV infusion every 4 weeks, from Week 0 through Week 48; IV infusion every 4 weeks, from Week 0 through Week 48
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CNTO 888; Idiopathic Pulmonary Fibrosis; IPF