NCT03955146

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

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: 393 (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 IPF.

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab 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. The study consists of the following study periods: * Main (double blind, placebo-controlled) phase: * Screening period: Up to 6 weeks * Treatment period: 48 weeks * Optional, open-label extension (OLE) phase of pamrevlumab: o Access to pamrevlumab will be available until the last participant completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first. * Follow-up period/final safety assessments: * 28 days after last dose * 60 days after last dose: follow-up phone call, for a final safety assessment During the treatment period, co-administration of an approved IPF therapy (that is, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment. Participants who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments. Participants who complete the Week 48 visit of the main study (regardless of the number of study drug infusions received) will be eligible to participate in the optional OLE phase of the study that offers continuing access to pamrevlumab regardless of randomization assignment in the main study.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Pamrevlumab	Pamrevlumab will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.

Timeline

• Start date: 2019-06-18
• Primary completion: 2023-03-20
• Completion: 2023-08-28
• First posted: 2019-05-17
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

125 sites across 9 countries: United States, Argentina, Australia, Chile, China, Hong Kong, Russia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study