Trials / Terminated
TerminatedNCT03573505
An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BG00011 | Administered as specified in the treatment arm. |
| DRUG | Placebo | Administered as specified in the treatment arm. |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2019-11-14
- Completion
- 2019-11-14
- First posted
- 2018-06-29
- Last updated
- 2020-12-11
- Results posted
- 2020-11-20
Locations
90 sites across 17 countries: United States, Argentina, Australia, Belgium, Chile, Czechia, Denmark, France, Greece, Israel, Italy, Netherlands, Poland, Russia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03573505. Inclusion in this directory is not an endorsement.