Trials / Completed
CompletedNCT02550873
A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.
Detailed description
PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic diseases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PRM-151 | PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks |
| OTHER | placebo | Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2017-05-02
- Completion
- 2017-05-02
- First posted
- 2015-09-16
- Last updated
- 2022-05-02
- Results posted
- 2018-12-14
Locations
18 sites across 7 countries: United States, Czechia, Germany, Italy, Netherlands, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02550873. Inclusion in this directory is not an endorsement.