Pulmonary FibrosisPhase 2NCT00786201
A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study testing CNTO 888 1 mg/kg, CNTO 888 5 mg/kg and CNTO 888 15 mg/kg in people with Pulmonary Fibrosis, run by Centocor, Inc. at 30 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- CNTO 888 1 mg/kg, CNTO 888 5 mg/kg and CNTO 888 15 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 30 sitesin 5 countries
- Study dates
- Dec 2008to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
30 sites in 5 countries.
30 sites in 5 countries
United States17 sites
Study site
Ann Arbor, Michigan
Study site
Birmingham, Alabama
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Colchester, Vermont
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Nashville, Tennessee
Study site
New Orleans, Louisiana
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
Spartanburg, South Carolina
Study site
Tampa, Florida
Study site
Wichita, Kansas
Canada6 sites
Study site
Edmonton, Alberta
Study site
Halifax, Nova Scotia
Study site
Hamilton, Ontario
Study site
London, Ontario
Study site
Vancouver
Study site
Winnipeg, Manitoba
Netherlands4 sites
Study site
Amsterdam
Study site
Nieuwegein
Study site
Rotterdam
Study site
Sittard
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Fibrosis
- Being tested
- Placebo, CNTO 888 1 mg/kg, CNTO 888 5 mg/kg, CNTO 888 15 mg/kg
- Keywords
- CNTO 888, Idiopathic Pulmonary Fibrosis, IPF
- Medical subject headings
- Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48
CNTO 888 1 mg/kgDrug
IV infusion every 4 weeks, from Week 0 through Week 48
CNTO 888 5 mg/kgDrug
IV infusion every 4 weeks, from Week 0 through Week 48
CNTO 888 15 mg/kgDrug
IV infusion every 4 weeks, from Week 0 through Week 48
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| CNTO 888 1 mg/kg | Experimental | Not described Receives: Drug: CNTO 888 1 mg/kg |
| CNTO 888 5 mg/kg | Experimental | Not described Receives: Drug: CNTO 888 5 mg/kg |
| CNTO 888 15 mg/kg | Experimental | Not described Receives: Drug: CNTO 888 15 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Percent Change (Relative to Baseline per 4 Week Interval) in Forced Vital Capacity (FVC) Through Week 52
The FVC is one component of pulmonary function testing, done with a spirometer.
Measured: Baseline through Week 52
Secondary outcomes (4)
Time to Disease Progression
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.
Measured: Baseline through Week 52
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 52
The FVC is one component of pulmonary function testing, done with a spirometer.
Measured: Baseline through Week 52
Relative Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 52
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.
Measured: Baseline through Week 52
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
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.
Measured: Baseline through Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786201
- Sponsor's protocol ID
- CR015235
- Other IDs
- CNTO888PUL2001
- Status last verified
- Nov 2015
- First submitted
- 4 Nov 2008
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Raghu G, Martinez FJ, Brown KK, Costabel U, Cottin V, Wells AU, Lancaster L, Gibson KF, Haddad T, Agarwal P, Mack M, Dasgupta B, Nnane IP, Flavin SK, Barnathan ES. CC-chemokine ligand 2 inhibition in idiopathic pulmonary fibrosis: a phase 2 trial of carlumab. Eur Respir J. 2015 Dec;46(6):1740-50. doi: 10.1183/13993003.01558-2014. Epub 2015 Oct 22.
PubMed 26493793
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00786201
- Acronym / sponsor ID
- CR015235
- Conditions
- Pulmonary Fibrosis
- Keywords
- CNTO 888, Idiopathic Pulmonary Fibrosis, IPF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| CNTO 888 1 mg/kg | Experimental | Drug: CNTO 888 1 mg/kg |
| CNTO 888 5 mg/kg | Experimental | Drug: CNTO 888 5 mg/kg |
| CNTO 888 15 mg/kg | Experimental | Drug: CNTO 888 15 mg/kg |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboIntravenous (IV) infusion every 4 weeks, from Week 0 through Week 48 | Drug | Placebo |
| CNTO 888 1 mg/kgIV infusion every 4 weeks, from Week 0 through Week 48 | Drug | CNTO 888 1 mg/kg |
| CNTO 888 5 mg/kgIV infusion every 4 weeks, from Week 0 through Week 48 | Drug | CNTO 888 5 mg/kg |
| CNTO 888 15 mg/kgIV infusion every 4 weeks, from Week 0 through Week 48 | Drug | CNTO 888 15 mg/kg |
Primary outcome
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
The FVC is one component of pulmonary function testing, done with a spirometer.
4 secondary outcomes
Time to Disease Progression
Time frame: Baseline through Week 52
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 52
Time frame: Baseline through Week 52
Relative Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 52
Time frame: Baseline through Week 52
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52
Time frame: Baseline through Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
- Results publication: PubMed 26493793Raghu G, Martinez FJ, Brown KK, Costabel U, Cottin V, Wells AU, Lancaster L, Gibson KF, Haddad T, Agarwal P, Mack M, Dasgupta B, Nnane IP, Flavin SK, Barnathan ES. CC-chemokine ligand 2 inhibition in idiopathic pulmonary fibrosis: a phase 2 trial of carlumab. Eur Respir J. 2015 Dec;46(6):1740-50. doi: 10.1183/13993003.01558-2014. Epub 2015 Oct 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
30 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CNTO 888 1 mg/kg, CNTO 888 5 mg/kg and CNTO 888 15 mg/kg in people with Pulmonary Fibrosis, run by Centocor, Inc. at 30 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Netherlands, Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.