Trials / Terminated
TerminatedNCT01769196
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 544 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 45 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Simtuzumab | 125 mg/mL single-dose vials administered subcutaneously once a week |
| DRUG | Simtuzumab placebo | Simtuzumab placebo single-dose vials administered subcutaneously once a week |
Timeline
- Start date
- 2013-01-31
- Primary completion
- 2016-02-23
- Completion
- 2016-02-23
- First posted
- 2013-01-16
- Last updated
- 2017-05-30
- Results posted
- 2017-04-13
Locations
175 sites across 14 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Israel, Italy, Poland, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01769196. Inclusion in this directory is not an endorsement.