An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
Public ClinicalTrials.gov record NCT03573505. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03573505
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 23, 2018
- Primary completion
- Nov 13, 2019
- Completion
- Nov 13, 2019
- Last update posted
- Dec 10, 2020
2018 – 2019
United States locations
- U.S. sites
- 26
- U.S. states
- 21
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | — |
| Research Site | Phoenix | Arizona | 85006 | — |
| Research Site | Phoenix | Arizona | 85013 | — |
| Research Site | Los Angeles | California | 90048 | — |
| Research Site | New Haven | Connecticut | 06510-3221 | — |
| Research Site | Miami | Florida | 33125 | — |
| Research Site | Atlanta | Georgia | 30322 | — |
| Research Site | Iowa City | Iowa | 52242 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Boston | Massachusetts | 02115 | — |
| Research Site | Minneapolis | Minnesota | 55407 | — |
| Research Site | Rochester | Minnesota | 55905 | — |
| Research Site | Chesterfield | Missouri | 63017 | — |
| Research Site | Kansas City | Missouri | 66160 | — |
| Research Site | Lebanon | New Hampshire | 03756 | — |
| Research Site | New York | New York | 10029 | — |
| Research Site | Cleveland | Ohio | 44195 | — |
| Research Site | Pittsburgh | Pennsylvania | 15213 | — |
| Research Site | Providence | Rhode Island | 02903 | — |
| Research Site | Charleston | South Carolina | 29425 | — |
| Research Site | Nashville | Tennessee | 37232 | — |
| Reserach Site | Houston | Texas | 77030 | — |
| Research Site | Falls Church | Virginia | 22042 | — |
| Research Site | Seattle | Washington | 98195 | — |
| Research Site | Tacoma | Washington | 98405 | — |
| Research Site | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03573505, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03573505 live on ClinicalTrials.gov.