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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00786201
• Date of registration: 04/11/2008
• Prospective Registration: Yes
• Primary sponsor: Centocor, Inc.
• Public title: A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
• Scientific 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
• Date of first enrolment: December 2008
• Target sample size: 126
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00786201
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Germany, Netherlands, United States

Contacts

• Name: Centocor, Inc. Clinical Trial
• Affiliation: Centocor, Inc.

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pulmonary Fibrosis

Intervention(s)

Drug: CNTO 888 1 mg/kg

Drug: Placebo

Drug: CNTO 888 5 mg/kg

Drug: CNTO 888 15 mg/kg

Primary Outcome(s)

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]

Secondary Outcome(s)

Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 52 [Time Frame: Baseline through Week 52]

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]

Secondary ID(s)

CNTO888PUL2001

CR015235

Source(s) of Monetary Support

Please refer to primary and secondary sponsors