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NCT03573505 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 2 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT03573505 is a Phase 2 study that was terminated before completion, run by Biogen. The registered enrollment target is 109 participants.
The verdict
NCT03573505, a Phase 2 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by change in percent predicted forced (expiratory) vital capacity (FVC); to assess progression-free survival in participants who receive BG00011 compared with placebo; to assess the occurrence of IPF exacerbation in participants who receive BG00011 compared with placebo; to assess the incidence of absolute decline in FVC ≥10% in participants who receive BG00011 compared with placebo; to assess the time to death or lung transplantation in participants who receive BG00011 compared with placebo, and the transplant-free survival rate at Week 26 and Week 52; to assess the time to non-elective hospitalizations in participants who receive BG00011 compared with placebo; to assess additional pulmonary function test (PFT) findings in participants who receive BG00011 compared with placebo; To assess performance on the 6 minute walk test (6MWT) in participants who receive BG00011 compared with placebo; to evaluate the safety and tolerability of BG00011; and to evaluate the serum concentration of BG00011.
Interventions
- DRUG Placebo
- DRUG BG00011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2018-09-24 |
| Est. Completion | 2019-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03573505
The ClinicalTrials.gov registry entry for NCT03573505 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03573505 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03573505 about?
NCT03573505 is a clinical study titled "An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis". The primary objective of this study is to evaluate the efficacy of BG00011 compared with placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). The secondary objectives of this study are: to evaluate the efficacy of BG00011 compared with placebo in participants with IPF as determined by c...
What is the current status of trial NCT03573505?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2018-09-24. Estimated completion is 2019-11-14.
What interventions are being tested in trial NCT03573505?
The interventions under investigation include: Placebo (DRUG), BG00011 (DRUG).
Who is sponsoring clinical trial NCT03573505?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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