A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
NCT02550873 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 117
Last updated 2022-05-02
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bernt van den Blink, MD, PhD · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-01
- Primary Completion
- 2017-05-02
- Completion
- 2017-05-02
Countries
- United States
- Czechia
- Germany
- Italy
- Netherlands
- Spain
- Switzerland
Study Locations
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