Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis

A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00063869

Enrollment

Registered

2003-07-09

Start date

Unknown

Completion date

2005-03-31

Last updated

2009-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis, Fibrosis, Pulmonary, Pulmonary Fibroses, Fibroses, Pulmonary

Brief summary

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).

Interventions

DRUGEtanercept

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026