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

NCT04419558 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: FGCL-3019-095
• Study Type: interventional
• Target: 372
• Locations: 25 countries
• Sites: 157

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; IPF; Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Lung Fibrosis

Outcome Measures

Primary Outcomes (1)

• DB Period: Change From Baseline in FVC at Week 48

  FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).

  Baseline, Week 48

Secondary Outcomes (6)

• DB Period: Time to Disease Progression

  Up to Week 48

• DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48

  Baseline, Week 48

• DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First

  Up to Week 48

• DB Period: Time to First Acute IPF Exacerbation

  Up to Week 48

• DB Period: Time to All-Cause Mortality

  Up to Week 48

Study Arms (2)

Pamrevlumab

EXPERIMENTAL

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

Drug: Pamrevlumab

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Pamrevlumab DRUG

Sterile solution for injection

Also known as: FG-3019

Pamrevlumab

Placebo DRUG

Sterile solution for injection

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous exposure to pamrevlumab.
• Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.
• Female participants who are pregnant or nursing.
• Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
• Interstitial lung disease other than IPF.
• Sustained improvement in the severity of IPF during the 12 months prior to screening.
• 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.
• 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).
• Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.
• 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.
• History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (157)

UAB Lung Health Center

Birmingham, Alabama, 35294, United States

Location

UC San Francisco

San Francisco, California, 94143, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

St. Francis Medical Center

Clearwater, Florida, 33765, United States

Location

Pulmonary Disease Specialists d/b/a PDS Research

Kissimmee, Florida, 34741, United States

Location

TGH/USF Center for Advanced Lung Disease and Lung Transplant

Tampa, Florida, 33606, United States

Location

Emory University/The Emory Clinic

Atlanta, Georgia, 30324, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

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

Boston, Massachusetts, 02114, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49504, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

PulmonIx, LLC

Greensboro, North Carolina, 27403, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Low Country Lung and Critical Care, PA

Charleston, South Carolina, 29406, United States

Location

The University of Vermont

Burlington, Vermont, 05405, United States

Location

University of Wisconsin Clinical Research

Madison, Wisconsin, 53706, United States

Location

Fundacion Respirar - Centro Médico Dra. De Salvo

Ciudad Autonoma de Buenos Aires (caba), Argentina

Location

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, 30130-100, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital Dia do Pulmão

Blumenau, Santa Catarina, 89030-101, Brazil

Location

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

Botucatu, São Paulo, 18618-686, Brazil

Location

CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

CPQuali Pesquisa Clínica Ltda.

São Paulo, 01228-000, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, 01323-001, Brazil

Location

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

São Paulo, 05403-000, Brazil

Location

BeiJing Chao-Yang Hospital,Capital Medical University

Beijing, China

Location

Beijing Frindship hosiptal capital Medical University

Beijing, China

Location

China Japan Friendship hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Sichuan People's Hospital

Chengdu, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Shanghai Oriental Hospital

Shanghai, China

Location

The First Hospital of China Medical University

Shenyang, China

Location

General Hospital of Tianjin Medical University

Tianjing, China

Location

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

Wuhan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

General Hospital of Ningxia Medical University

Yinchuan, China

Location

Fundación Santa Fe de Bogotá

Bogotá, 110121, Colombia

Location

Fundación Neumológica Colombiana

Bogotá, 110131, Colombia

Location

Healthy Medical Center S.A.S

Zipaquirá, 250252, Colombia

Location

Fakultní nemocnice Brno

Brno, 625 00, Czechia

Location

Nemocnice Jihlava

Jihlava, 586 33, Czechia

Location

Nemocnice Na Bulovce, Klinika pneumologie

Prague, 18081, Czechia

Location

Aarhus Universitets Hospital

Aarhus, DK-8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Centro de Obstetricia y Ginecologia

Santo Domingo, 10205, Dominican Republic

Location

Centro Medico Dominicano

Santo Domingo, 456, Dominican Republic

Location

University Hospital Avicenne

Bobigny, 93000, France

Location

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

Bron, 69677, France

Location

CHU de Caen

Caen, 14033, France

Location

Centre Memoire Ressources Recherche, Hopital F. MITTERRAND

Dijon, 21079, France

Location

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

Montpellier, 34295, France

Location

CHU de Nice Hôpital Pasteur

Nice, 06000, France

Location

Hôpital Bichat - Claude Bernard

Paris, 75018, France

Location

CHU de Reims Hopital Maison Blanche

Reims, 51092, France

Location

CHU de Rennes Hôpital Pontchaillou

Rennes, 35033, France

Location

Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours

Tours, 37044, France

Location

Research Institute Of Clinical Medicine Todua Clinic

Tbilisi, 0112, Georgia

Location

Clinic Diacor

Tbilisi, 0159, Georgia

Location

Ruhrlandklinik-Universitaetsmedizin Essen

Essen, 45239, Germany

Location

Klinik Schillerhoehe

Gerlingen, 70839, Germany

Location

Agaplesion Evangelisches Krankenhaus Mittelhessen

Giessen, 035398, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

University of Munich

Munich, 81377, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Institut fur Pneumologie an der Universitat zu Koln

Solingen, 83022, Germany

Location

Semmelweis University Clinic of Pulmonology

Budapest, 1083, Hungary

Location

Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly

Budapest, 1121, Hungary

Location

Fejer Megyei Szent Gyorgy kh

Székesfehérvár, 8000, Hungary

Location

Pulmonology Hospital

Törökbálint, 2045, Hungary

Location

Royal College of Surgeons in Ireland

Dublin, D09YD60, Ireland

Location

Gaspare Rodiloco Hospital

Catania, 95123, Italy

Location

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

Forlì, 47121, Italy

Location

Ospedale San Giuseppe

Milan, 20123, Italy

Location

AOU Policlinico di Modena

Modena, 41124, Italy

Location

Monaldi Hospital

Naples, 80131, Italy

Location

Azienda Ospedaliera Universitaria di Padova

Padua, 35128, Italy

Location

IRCCS Fondazione San Matteo di Pavia

Pavia, 27100, Italy

Location

Agostina Gemelli University Polyclinic

Rome, 00168, Italy

Location

Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"

Siena, 53100, Italy

Location

Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino

Torino, 0126, Italy

Location

Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"

Torrette, 60126, Italy

Location

American University of beirut medical center

Beirut, Lebanon

Location

Hotel Dieu De France

Beirut, Lebanon

Location

Rafik Hariri University Hospital (Clinical Research Unit)

Bir Hassan, Lebanon

Location

Instituto Nacional de Enfermedades Respiratorias INER

México, 14080, Mexico

Location

Unidad Medica para la Salud Integral (UMSI)

México, 66465, Mexico

Location

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

México, 97070, Mexico

Location

St. Lucas Clinical Research Center SA de CV

México, CP97217, Mexico

Location

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

Monterrey, 64460, Mexico

Location

Oaxaca Site Management Organization S.C. (OSMO)

Oaxaca City, 68000, Mexico

Location

Dept. of Pulmonary Diseases

Amsterdam, 30.033, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Longarts - Opleider Longziekten Zuyderland MC

Heerlen, 6419, Netherlands

Location

St. Antonius Ziekenhuis BV

Nieuwegein, 3435, Netherlands

Location

Canisius-Wilhelmina Ziekenhuis

Nieuwegein, 6533, Netherlands

Location

Clinica Internacional

Lima, 15001, Peru

Location

Clinica San Pablo

Lima, 150140, Peru

Location

Clinica Providencia

Lima, 15088, Peru

Location

Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

Lima, 15102, Peru

Location

Centro de Investigacion Ricardo Palma

San Isidro, 150131, Peru

Location

Clinica La luz

Santa Beatriz, 15046, Peru

Location

Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

Będzin, 42-500, Poland

Location

Centrum Medycyny Oddechowej Mroz SJ

Bialystok, 15-044, Poland

Location

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

Katowice, 40-635, Poland

Location

University Hospital No1

Lodz, 90-153, Poland

Location

Instytut Gruzlicy i Chorob Pluc

Warsaw, 01-138, Poland

Location

Municipal Institute for Lung Diseases and Tuberculosis

Belgrade, 11000, Serbia

Location

University Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

University Clinical Center of Nis

Niš, 18000, Serbia

Location

Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Soonchunhyang University Hospital Bucheon

Bucheon-si, 14584, South Korea

Location

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

Bucheon-si, 14647, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Inje University Hospital Iisan Paik Hospital

Goyang, 10380, South Korea

Location

Chonnam National University Hospital

Gwangju, 61469, South Korea

Location

Gachon University Gil Medical Centre

Incheon, 21565, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kyunghee University Medical Center

Seoul, 17104, South Korea

Location

Severance hospital

Seoul, 3722, South Korea

Location

Soonchunhyang University Hospital Seoul

Seoul, 4401, South Korea

Location

Asan Medical Center

Seoul, 5505, South Korea

Location

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

Seoul, 7345, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 8036, Spain

Location

Hospital Universitaio de La Princesa

Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

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

Madrid, 28040, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitario Nuestra Senora de Valme

Seville, 41014, Spain

Location

Universitätsklinik für Pneumologie

Bern, 3010, Switzerland

Location

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

Dnipro, 49069, Ukraine

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kyiv, 03680, Ukraine

Location

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit

Cambridge, CB2 0AY, United Kingdom

Location

The Princess Alexandra Hospital NHS Trust

Harlow, CM20 1QX, United Kingdom

Location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

University College London

London, WC1E 6JF, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M23 9LT, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial; Pulmonary Fibrosis

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

zephyrus@fibrogen.com

(415) 978-1427

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 5, 2020
• Study Start: September 30, 2020
• Primary Completion: September 4, 2023
• Study Completion: September 4, 2023
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-08

Locations

CN (15); PE (6); DO (2); GE (2); NL (5); CO (3); AR (1); HU (4); PL (5); UA (3); BR (9); DK (2); FR (10); CZ (3); DE (7); IE (1); IT (11); ME (6); SE (4); KR (15); ES (8); US (23); LE (3); CH (1); GB (8)