Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis
Status and phase
Completed
Phase 2
Conditions
Pulmonary Fibrosis
Treatments
Drug: Etanercept
Details and patient eligibility
About
The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).
Enrollment
88 patients
Sex
All
Ages
40 to 80 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Diagnosis of IPF based on American Thoracic Society (ATS) guidelines
Exclusion criteria
- Subjects with end-stage
- Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor)
- Receipt of any investigational drug or biological agent within 4 weeks of screening visit
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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