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

NCT ID: NCT04419558

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2023-09-04

Brief 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.

Detailed Description

The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy 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.

During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment.

Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pamrevlumab

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

Group Type: EXPERIMENTAL

Pamrevlumab

Intervention Type: DRUG

Sterile solution for injection

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Sterile solution for injection

Interventions

Pamrevlumab

Sterile solution for injection

Intervention Type: DRUG

Placebo

Sterile solution for injection

Intervention Type: DRUG

Other Intervention Names

FG-3019

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.

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

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

4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.

5. Not currently receiving treatment for IPF with an approved therapy for IPF (such as, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.

Exclusion Criteria

1. Previous exposure to pamrevlumab.

2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.

3. Female participants who are pregnant or nursing.

4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.

5. Interstitial lung disease other than IPF.

6. Sustained improvement in the severity of IPF during the 12 months prior to screening.

7. Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.

8. 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).

9. Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.

10. Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week prior to screening.

11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UAB Lung Health Center

Birmingham, Alabama, United States

UC San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

Yale University

New Haven, Connecticut, United States

St. Francis Medical Center

Clearwater, Florida, United States

Pulmonary Disease Specialists d/b/a PDS Research

Kissimmee, Florida, United States

TGH/USF Center for Advanced Lung Disease and Lung Transplant

Tampa, Florida, United States

Emory University/The Emory Clinic

Atlanta, Georgia, United States

University of Iowa

Iowa City, Iowa, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

The General Hospital Corporation d/b/a Massachusetts General Hospital

Boston, Massachusetts, United States

Spectrum Health

Grand Rapids, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Duke University Medical Center

Durham, North Carolina, United States

PulmonIx, LLC

Greensboro, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Low Country Lung and Critical Care, PA

Charleston, South Carolina, United States

The University of Vermont

Burlington, Vermont, United States

University of Wisconsin Clinical Research

Madison, Wisconsin, United States

Fundacion Respirar - Centro Médico Dra. De Salvo

Ciudad Autonoma de Buenos Aires (caba), , Argentina

Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG

Belo Horizonte, Minas Gerais, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Dia do Pulmão

Blumenau, Santa Catarina, Brazil

Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP

Botucatu, São Paulo, Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP

São Bernardo do Campo, São Paulo, Brazil

CPQuali Pesquisa Clínica Ltda.

São Paulo, , Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

São Paulo, , Brazil

BeiJing Chao-Yang Hospital,Capital Medical University

Beijing, , China

Beijing Frindship hosiptal capital Medical University

Beijing, , China

China Japan Friendship hospital

Beijing, , China

Peking Union Medical College Hospital

Beijing, , China

Sichuan People's Hospital

Chengdu, , China

Guangdong Provincial People's Hospital

Guangzhou, , China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, , China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Shanghai Oriental Hospital

Shanghai, , China

The First Hospital of China Medical University

Shenyang, , China

General Hospital of Tianjin Medical University

Tianjing, , China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, , China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

General Hospital of Ningxia Medical University

Yinchuan, , China

Fundación Santa Fe de Bogotá

Bogotá, , Colombia

Fundación Neumológica Colombiana

Bogotá, , Colombia

Healthy Medical Center S.A.S

Zipaquirá, , Colombia

Fakultní nemocnice Brno

Brno, , Czechia

Nemocnice Jihlava

Jihlava, , Czechia

Nemocnice Na Bulovce, Klinika pneumologie

Prague, , Czechia

Aarhus Universitets Hospital

Aarhus, , Denmark

Odense University Hospital

Odense, , Denmark

Centro de Obstetricia y Ginecologia

Santo Domingo, , Dominican Republic

Centro Medico Dominicano

Santo Domingo, , Dominican Republic

University Hospital Avicenne

Bobigny, , France

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Bron, , France

CHU de Caen

Caen, , France

Centre Memoire Ressources Recherche, Hopital F. MITTERRAND

Dijon, , France

C.H.R.U. de Montpellier - Hôpital Lapeyronie

Montpellier, , France

CHU de Nice Hôpital Pasteur

Nice, , France

Hôpital Bichat - Claude Bernard

Paris, , France

CHU de Reims Hopital Maison Blanche

Reims, , France

CHU de Rennes Hôpital Pontchaillou

Rennes, , France

Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours

Tours, , France

Research Institute Of Clinical Medicine Todua Clinic

Tbilisi, , Georgia

Clinic Diacor

Tbilisi, , Georgia

Ruhrlandklinik-Universitaetsmedizin Essen

Essen, , Germany

Klinik Schillerhoehe

Gerlingen, , Germany

Agaplesion Evangelisches Krankenhaus Mittelhessen

Giessen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

University of Munich

Munich, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Institut fur Pneumologie an der Universitat zu Koln

Solingen, , Germany

Semmelweis University Clinic of Pulmonology

Budapest, , Hungary

Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly

Budapest, , Hungary

Fejer Megyei Szent Gyorgy kh

Székesfehérvár, , Hungary

Pulmonology Hospital

Törökbálint, , Hungary

Royal College of Surgeons in Ireland

Dublin, , Ireland

Gaspare Rodiloco Hospital

Catania, , Italy

Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli

Forlì, , Italy

Ospedale San Giuseppe

Milan, , Italy

AOU Policlinico di Modena

Modena, , Italy

Monaldi Hospital

Naples, , Italy

Azienda Ospedaliera Universitaria di Padova

Padua, , Italy

IRCCS Fondazione San Matteo di Pavia

Pavia, , Italy

Agostina Gemelli University Polyclinic

Rome, , Italy

Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"

Siena, , Italy

Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino

Torino, , Italy

Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"

Torrette, , Italy

American University of beirut medical center

Beirut, , Lebanon

Hotel Dieu De France

Beirut, , Lebanon

Rafik Hariri University Hospital (Clinical Research Unit)

Bir Hassan, , Lebanon

Instituto Nacional de Enfermedades Respiratorias INER

México, , Mexico

Unidad Medica para la Salud Integral (UMSI)

México, , Mexico

Medical Care and Research S.A. de C.V.

México, , Mexico

St. Lucas Clinical Research Center SA de CV

México, , Mexico

Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, , Mexico

Oaxaca Site Management Organization S.C. (OSMO)

Oaxaca City, , Mexico

Dept. of Pulmonary Diseases

Amsterdam, , Netherlands

Catharina Hospital

Eindhoven, , Netherlands

Longarts - Opleider Longziekten Zuyderland MC

Heerlen, , Netherlands

St. Antonius Ziekenhuis BV

Nieuwegein, , Netherlands

Canisius-Wilhelmina Ziekenhuis

Nieuwegein, , Netherlands

Clinica Internacional

Lima, , Peru

Clinica San Pablo

Lima, , Peru

Clinica Providencia

Lima, , Peru

Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

Lima, , Peru

Centro de Investigacion Ricardo Palma

San Isidro, , Peru

Clinica La luz

Santa Beatriz, , Peru

Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

Będzin, , Poland

Centrum Medycyny Oddechowej Mroz SJ

Bialystok, , Poland

Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, , Poland

University Hospital No1

Lodz, , Poland

Instytut Gruzlicy i Chorob Pluc

Warsaw, , Poland

Municipal Institute for Lung Diseases and Tuberculosis

Belgrade, , Serbia

University Clinical Center of Serbia

Belgrade, , Serbia

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, , Serbia

University Clinical Center of Nis

Niš, , Serbia

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Soonchunhyang University Hospital Bucheon

Bucheon-si, , South Korea

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, , South Korea

Inje University Haeundae Paik Hospital

Busan, , South Korea

Inje University Hospital Iisan Paik Hospital

Goyang, , South Korea

Chonnam National University Hospital

Gwangju, , South Korea

Gachon University Gil Medical Centre

Incheon, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Kyunghee University Medical Center

Seoul, , South Korea

Severance hospital

Seoul, , South Korea

Soonchunhyang University Hospital Seoul

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, , South Korea

Ulsan University Hospital

Ulsan, , South Korea

Hospital Universitario de Bellvitge

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

Hospital Universitaio de La Princesa

Madrid, , Spain

Hospital General Universitario Gregorio Maranon

Madrid, , Spain

Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n

Madrid, , Spain

Hospital Universitario Quironsalud Madrid

Madrid, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Hospital Universitario Nuestra Senora de Valme

Seville, , Spain

Universitätsklinik für Pneumologie

Bern, , Switzerland

Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil

Dnipro, , Ukraine

Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council

Ivano-Frankivsk, , Ukraine

National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department

Kyiv, , Ukraine

Medway NHS Foundation Trust

Gillingham, Kent, United Kingdom

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

Birmingham, , United Kingdom

Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit

Cambridge, , United Kingdom

The Princess Alexandra Hospital NHS Trust

Harlow, , United Kingdom

Royal Brompton Hospital

London, , United Kingdom

University College London

London, , United Kingdom

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Southampton General Hospital

Southampton, , United Kingdom

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

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

FGCL-3019-095

Identifier Type: -

Identifier Source: org_study_id