Idiopathic pulmonary fibrosis (IPF) MedDRA version: 9.1 Level: LLT Classification code 10021240 Term: Idiopathic pulmonary fibrosis
Conditions
Interventions
Product Name: CNTO888
Product Code: CNTO888
Pharmaceutical Form: Powder for solution for infusion
Current Sponsor code: CNTO888
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrat
Sponsors
Centocor B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 40 to 80, inclusive. a. Subjects who are aged 40 years to 50 years. b. Insidious onset of otherwise unexplained dyspnea on exertion. c. Duration of illness = 3 months. d. Bibasilar, inspiratory crackles (dry or “Velcro-type” in quality). 3. Have surgical lung biopsy evidence of UIP and/or HRCT scan-based diagnosis of IPF. In the absence of surgical lung biopsy, an HRCT scan obtained within 3 months prior to or at screening must be available for review. 4. Have evidence of progressive IPF disease activity despite current treatment. Progressive IPF disease activity, for the purposes of this protocol, is defined as having 1 or more of the following within the past 12 months: a. Relative decrease of = 10% in FVC. b. Relative decrease of = 15% in DLCO. c. Evidence of clinically significant worsening on HRCT (eg, development of honeycombing, increase in opacities). d. Significant worsening of dyspnea at rest or with exertion. 5. Evidence of recent stability of percent-predicted FVC (defined as not having changed > 15% at the baseline visit relative to the screening visit). 6. FVC = 50% of the predicted value at screening. 7. Women of childbearing potential must have a negative serum pregnancy test result at screening. Women of childbearing potential and all men must be using adequate birth control measures and must agree to continue to use such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last infusion of study agent. 8. Are considered eligible according to the following TB screening criteria: a. Have no history of latent or active TB prior to screening. b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination. c. Have had no recent close contact with a person with active TB. d. Within 2 months prior to the first administration of study agent, have negative diagnostic TB test results (defined as a negative QuantiFERON-TB Gold test). e. Have a chest radiograph (both posterior-anterior and lateral views) if clinically indicated or HRCT taken within 3 months prior to screening and read by a qualified radiologist, with no clear evidence of current active TB or old inactive TB. 9. Capable of understanding subject assessment forms. 10. Have provided signed, written, informed consent before receiving any protocol specific procedures. 11. Willing to adhere to the study visit schedule and o
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria may not be enrolled in the study: 1. Have evidence of interstitial pneumonia other than IPF. 2. Diagnosis of IPF is not confirmed by HRCT or lung biopsy results. 3. Partial pressure of oxygen in arterial blood (PaO2) 2 times the upper limit of normal at screening. 13. Within 3 months prior to screening, have had a clinically important, serious infection (eg, hepatitis, pneumonia, or pyelonephritis), have been hospitalized for an infection, or have been treated with IV antibiotics for an infection. Less serious infections (eg, acute upper respiratory tract infection or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator. 14. Opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii) within 6 months prior to screening. 15. Received any live attenuated vaccination (eg, FluMist) within 3 months prior to screening or are expected to receive any live attenuated vaccinations during the trial or up to 3 months after the last administration of study agent. Inactivated, injectable influenza and pneumococcal vaccines are permissible. 16. Serious concomitant illness that could interfere with the subject’s participation in the study. 17. History of substance abuse (drugs or alcohol) within the 3 years prior to screening, history of noncompliance to medical regimens, or other condition/circumstance that could interfere with the subject’s adherence to protocol requirements (eg, psychiatric disease, lack of motivation, travel). 18. Major surgery within 1 month prior to screening or planned surgery during the study. 19. Currently listed for lung transplantation. 20. Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence for at least 3 months). 21. Have a transplanted organ (with the exceptio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To determine the efficacy (as measured by pulmonary function) and safety of CNTO 888 in subjects with IPF.;Secondary Objective: • To assess the effect of CNTO 888 on measures of disease progression. • To assess the effect of CNTO 888 on patient reported outcomes, functional capacity measurements, and health-related quality of life in subjects with IPF. • To assess the PK and PD of CNTO 888 in subjects with IPF.;Primary end point(s): The primary endpoint of this study is the rate of percent change (relative to baseline per 4-week interval) in FVC through Week 52. | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed