- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786201
A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
November 24, 2015 updated by: Centocor, Inc.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium
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Vancouver, Canada
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Alberta
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Edmonton, Alberta, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Bad Berka, Germany
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Essen, Germany
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Amsterdam, Netherlands
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Nieuwegein, Netherlands
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Rotterdam, Netherlands
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Sittard, Netherlands
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Alabama
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Birmingham, Alabama, United States
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Arizona
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Phoenix, Arizona, United States
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Florida
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Miami, Florida, United States
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Tampa, Florida, United States
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Illinois
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Chicago, Illinois, United States
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Kansas
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Wichita, Kansas, United States
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Louisiana
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New Orleans, Louisiana, United States
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Michigan
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Ann Arbor, Michigan, United States
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Minnesota
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Minneapolis, Minnesota, United States
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Ohio
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Cincinnati, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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South Carolina
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Charleston, South Carolina, United States
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Spartanburg, South Carolina, United States
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Tennessee
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Nashville, Tennessee, United States
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Utah
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Salt Lake City, Utah, United States
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Vermont
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Colchester, Vermont, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48
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EXPERIMENTAL: CNTO 888 1 mg/kg
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IV infusion every 4 weeks, from Week 0 through Week 48
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EXPERIMENTAL: CNTO 888 5 mg/kg
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IV infusion every 4 weeks, from Week 0 through Week 48
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EXPERIMENTAL: CNTO 888 15 mg/kg
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IV infusion every 4 weeks, from Week 0 through Week 48
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Rate of Percent Change (Relative to Baseline per 4 Week Interval) in Forced Vital Capacity (FVC) Through Week 52
Time Frame: Baseline through Week 52
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The FVC is one component of pulmonary function testing, done with a spirometer.
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Baseline through Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Disease Progression
Time Frame: Baseline through Week 52
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The time to disease progression is defined as the time in days from randomization to occurrence of acute idiopathic pulmonary fibrosis (IPF) exacerbation or lung transplantation or all-cause mortality, whichever occurs first.
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Baseline through Week 52
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Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 52
Time Frame: Baseline through Week 52
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The FVC is one component of pulmonary function testing, done with a spirometer.
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Baseline through Week 52
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Relative Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 52
Time Frame: Baseline through Week 52
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The DLCO is a sensitive lung function parameter and is performed to determine how well oxygen passes from the air sacs of the lungs into the blood.
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Baseline through Week 52
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Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Time Frame: Baseline through Week 52
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The SGRQ is a 76-item questionnaire designed to measure the impact of respiratory disease and its treatment on the participants' health outcomes.
The SGRQ is divided into 3 components: 1) symptoms, 2) activity limitations and 3) Impacts on social and psychological functioning.
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Baseline through Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
November 4, 2008
First Submitted That Met QC Criteria
November 4, 2008
First Posted (ESTIMATE)
November 6, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 28, 2015
Last Update Submitted That Met QC Criteria
November 24, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015235
- CNTO888PUL2001 (OTHER: Centocor)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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