STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis (IPF)

In brief

The primary objective of this study is to evaluate the safety and tolerability of subcutaneously (SC) administered multiple, escalating doses of BG00011 (a humanized monoclonal antibody directed against the alpha v beta 6 (αvβ6) integrin, formerly known as STX-100) in participants with IPF. The Secondary objectives are to estimate the pharmacokinetic (PK) parameters after the 1st dose and after the last dose of multiple, escalating doses of BG00011 in participants with IPF, to assess the immunogenicity of BG00011 in participants with IPF, and to assess the effect of BG00011 on biomarkers isolated from bronchoalveolar lavage (BAL) and peripheral blood in participants with IPF.

Key facts

Study ID
NCT01371305
Run by
Biogen
People needed
41
Starts
2012-07-16
Expected to finish
2017-03-31
Last updated by the study team
2020-02-28

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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