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

NCT03955146 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 393

Last updated 2024-09-19

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 IPF.

Conditions

Interventions

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.

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
2019-06-18
Primary Completion
2023-03-20
Completion
2023-08-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Chile
  • China
  • Hong Kong
  • Russia
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT03955146 on ClinicalTrials.gov