NCT04419558

Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 372 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.

Detailed description

The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to: * Intolerant or not responsive to approved IPF therapies * Ineligible to receive these therapies * Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study. During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment. Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Pamrevlumab	Sterile solution for injection
DRUG	Placebo	Sterile solution for injection

Timeline

• Start date: 2020-09-30
• Primary completion: 2023-09-04
• Completion: 2023-09-04
• First posted: 2020-06-05
• Last updated: 2024-08-12
• Results posted: 2024-08-12

Locations

157 sites across 25 countries: United States, Argentina, Brazil, China, Colombia, Czechia, Denmark, Dominican Republic, France, Georgia, Germany, Hungary, Ireland, Italy, Lebanon, Mexico, Netherlands, Peru, Poland, Serbia, South Korea, Spain, Switzerland, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study