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NCT01371305 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF), sponsored by Biogen.

Completed
Registry status
Phase 2
Development phase
41
Enrollment target
10
Study locations

NCT01371305 is a Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF) that has completed, run by Biogen. The registered enrollment target is 41 participants, below the 492-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (92% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT01371305, a Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF), has completed, sponsored by Biogen.

COMPLETED
Registry status
Phase 2
Development phase
41 participants
Enrollment target
10
Study locations

Study Summary

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.

Conditions Studied

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

  • DRUG Placebo
  • DRUG BG00011

Study Locations (10)

Massachusetts

  • Research Site - Boston
  • Research Site - Boston

California

  • Research Site - San Francisco

Georgia

  • Research Site - Atlanta

Kansas

  • Research Site - Kansas City

New Hampshire

  • Research Site - Lebanon

Ohio

  • Research Site - Cleveland

Pennsylvania

  • Research Site - Pittsburgh

Tennessee

  • Research Site - Nashville

Trial Details

FieldValue
Enrollment Target 41 participants
Start Date 2012-07-16
Est. Completion 2017-03-31
Phase Phase 2

Sponsor

Biogen

334 total trials

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What the Registry Record Tells You About NCT01371305

The ClinicalTrials.gov registry entry for NCT01371305 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 492-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (92% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Idiopathic Pulmonary Fibrosis (IPF) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01371305 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Massachusetts, California, Georgia.

Frequently Asked Questions

What is clinical trial NCT01371305 about?

NCT01371305 is a clinical study titled "STX-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)". 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 Seco...

What is the current status of trial NCT01371305?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2012-07-16. Estimated completion is 2017-03-31.

What conditions does trial NCT01371305 study?

This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis (IPF).

What interventions are being tested in trial NCT01371305?

The interventions under investigation include: Placebo (DRUG), BG00011 (DRUG).

Who is sponsoring clinical trial NCT01371305?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01371305 being conducted?

This trial has 10 study locations across California, Georgia, Kansas, Massachusetts, New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.