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

NCT04419558 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2024-08-12

Study results available
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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.

Conditions

Interventions

DRUG

Pamrevlumab

Sterile solution for injection

DRUG

Placebo

Sterile solution for injection

Sponsors & Collaborators

  • FibroGen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2023-09-04
Completion
2023-09-04
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04419558 on ClinicalTrials.gov