A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00786201
First received: November 4, 2008
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Fibrosis
Drug: Placebo
Drug: CNTO 888 1 mg/kg
Drug: CNTO 888 5 mg/kg
Drug: CNTO 888 15 mg/kg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The primary objective is to determine the efficacy (as measured by pulmonary function) and safety of CNTO 888 in subjects with IPF.

Secondary Outcome Measures:
  • To assess the effect of CNTO 888 on measures of disease progression, patient reported outcomes, functional capacity and health-related quality of life, and to assess the pharmacokinetics and pharmacodynamics of CNTO 888 in subjects with IPF.

Enrollment: 126
Study Start Date: December 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48
Experimental: CNTO 888 1 mg/kg Drug: CNTO 888 1 mg/kg
IV infusion every 4 weeks, from Week 0 through Week 48
Experimental: CNTO 888 5 mg/kg Drug: CNTO 888 5 mg/kg
IV infusion every 4 weeks, from Week 0 through Week 48
Experimental: CNTO 888 15 mg/kg Drug: CNTO 888 15 mg/kg
IV infusion every 4 weeks, from Week 0 through Week 48

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. Subjects followed until trial completed.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Forced Vital Capacity (FVC) >= (greater than or equal to) 50% of the predicted value at screening
  • Abnormal lung function test results that include evidence of restriction and impaired gas exchange, or evidence of desaturation at rest or exercise or decreased diffusing capacity of the lung for carbon monoxide (DLCO)
  • Bibasilar reticular abnormalities with minimal ground-glass opacities on high-resolution computed tomography (HRCT) scans
  • Have surgical lung biopsy evidence of usual interstitial pneumonia (UIP) and/or HRCT scan-based diagnosis of IPF
  • Relative decrease of >= 10% in forced vital capacity (FVC), or relative decrease of >= 15% in DLCO, or evidence of clinically significant worsening on HRCT (eg, development of honeycombing, increase in opacities), or significant worsening of dyspnea at rest or with exertion.

Exclusion Criteria:

  • Have evidence of interstitial pneumonia other than IPF
  • Diagnosis of IPF is not confirmed by HRCT or lung biopsy results
  • Partial pressure of oxygen in arterial blood (PaO2) < 55 mmHg (sea level) or 50 mmHg (altitude) at rest on room air
  • Have a diagnosis of other significant respiratory disorder (eg, asthma, tuberculosis (TB), sarcoidosis, aspergillosis, chronic obstructive pulmonary disease [COPD], or cystic fibrosis)
  • Have obstruction on prebronchodilator pulmonary function tests (PFTs) (defined as FEV1/FVC < 0.7) at screening or demonstrate an increase in FEV1 >= 12% postbronchodilator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786201

  Show 30 Study Locations
Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00786201     History of Changes
Other Study ID Numbers: CR015235, CNTO888PUL2001
Study First Received: November 4, 2008
Last Updated: December 28, 2012
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
United States: Federal Government

Keywords provided by Centocor, Inc.:
CNTO 888
Idiopathic Pulmonary Fibrosis
IPF

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on July 26, 2014