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COMPLETED Phase 2

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

NCT01371305 · View on ClinicalTrials.gov ↗

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.

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

74 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01371305

The ClinicalTrials.gov registry entry for NCT01371305 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01371305 reports 10 study locations spanning 9 distinct geographic areas — top geographies include Massachusetts, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01371305?

The interventions under investigation include: Placebo (DRUG), BG00011 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01371305?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial