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

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.

Timeline

Start

2020-09-30

Primary completion

2023-09-04

Completion

2023-09-04

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor Decision”

registry analysis (other test); Pamrevlumab vs Placebo; p = 0.6579; LS Mean Difference 0.03 (95% CI -0.12 to 0.19); Mixed Models Analysis NCT04419558 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pamrevlumab	Monoclonal antibody	30 mg/kg	Intravenous

Indications