NCT00786201

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Typical duration for phase_2

Geographic Reach
5 countries

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

December 28, 2015

Status Verified

November 1, 2015

Enrollment Period

3.1 years

First QC Date

November 4, 2008

Last Update Submit

November 24, 2015

Conditions

Pulmonary Fibrosis

Keywords

CNTO 888Idiopathic Pulmonary FibrosisIPF

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline through Week 52

Secondary Outcomes (4)

  • Time to Disease Progression

    Baseline through Week 52

  • Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 52

    Baseline through Week 52

  • Relative Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) at Week 52

    Baseline through Week 52

  • Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52

    Baseline through Week 52

Study Arms (4)

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

Interventions

PlaceboDRUG

Intravenous (IV) infusion every 4 weeks, from Week 0 through Week 48

Placebo
CNTO 888 1 mg/kgDRUG

IV infusion every 4 weeks, from Week 0 through Week 48

CNTO 888 1 mg/kg
CNTO 888 5 mg/kgDRUG

IV infusion every 4 weeks, from Week 0 through Week 48

CNTO 888 5 mg/kg
CNTO 888 15 mg/kgDRUG

IV infusion every 4 weeks, from Week 0 through Week 48

CNTO 888 15 mg/kg

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Wichita, Kansas, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Spartanburg, South Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Colchester, Vermont, United States

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Edmonton, Alberta, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

Halifax, Nova Scotia, Canada

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Vancouver, Canada

Location

Unknown Facility

Bad Berka, Germany

Location

Unknown Facility

Essen, Germany

Location

Unknown Facility

Amsterdam, Netherlands

Location

Unknown Facility

Nieuwegein, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Sittard, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 26493793RESULT

MeSH Terms

Conditions

Pulmonary FibrosisIdiopathic Pulmonary Fibrosis

Interventions

carlumab

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 6, 2008

Study Start

December 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

December 28, 2015

Record last verified: 2015-11

Locations

DE(2)BE(1)NL(4)CA(6)US(17)