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

Recruiting in Palo Alto (17 mi)

+187 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: FibroGen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests pamrevlumab, an IV drug given regularly, in people with IPF who can't use or don't benefit from existing treatments. The drug aims to stop lung scarring.

Eligibility Criteria

Inclusion Criteria

You are not currently taking approved medication for idiopathic pulmonary fibrosis (IPF) or have chosen to stop taking it after discussing the risks and benefits with the investigator.

High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing

FVCpp value >45% and <95% at Screening and Day 1 (prior to randomization)

+4 more

Exclusion Criteria

Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers)

Female participants who are pregnant or nursing

You have other respiratory diseases that could affect the main goal of the study or prevent you from participating. This includes diseases in different parts of the respiratory system like the lungs, chest wall, or airways.

+8 more

Participant Groups

2Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks

Group II: PamrevlumabExperimental Treatment1 Intervention

Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks. Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks