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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: Completed Phase 2 study of Idiopathic Pulmonary Fibrosis (IPF), sponsored by Biogen.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2012-07-16 |
| Est. Completion | 2017-03-31 |
| Phase | Phase 2 |
What the finished NCT01371305 record still lists
NCT01371305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 492-participant average among 8 other Idiopathic Pulmonary Fibrosis (IPF) trials with a reported enrollment target (92% lower).
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 lists 10 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis (IPF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01371305's enrollment target sits among peer trials
41 7th of 8 higher than 2 of 8 other Idiopathic Pulmonary Fibrosis (IPF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis (IPF) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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