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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04552899
Other study ID # WA42293
Secondary ID 2020-000791-38
Status Completed
Phase Phase 3
First received
Last updated
Start date March 19, 2021
Est. completion date February 10, 2023

Study information

Verified date May 2023
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).


Recruitment information / eligibility

Status Completed
Enrollment 665
Est. completion date February 10, 2023
Est. primary completion date February 10, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria: - Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline - High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB) - Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test (6MWT) during screening - FVC >/= 45% predicted during screening as determined by the over-reader - Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader - Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to (</=) 90% of predicted at screening as determined by the over-reader - If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening - If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment >/= 4 weeks prior to screening and during screening - Anticipated life expectancy of at least 12 months at baseline - Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study. - For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception - For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm - Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment - For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry Exclusion Criteria: - Evidence of other known causes of Interstitial Lung Disease (ILD) - FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value - Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT - Receiving nintedanib in combination with pirfenidone - Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening - Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during screening - Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit - Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay]) - Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level) during screening - Class IV New York Heart Association chronic heart failure - Historical evidence of left ventricular ejection fraction < 35% - Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study - Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial - History of smoking, alcohol or substance abuse disorder, or a malignancy - Previous treatment with PRM-151 - Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula - Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant - Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151 - Women of childbearing potential (Only for participants enrolling in Japan)

Study Design


Intervention

Drug:
PRM-151 (Zinpentraxin Alfa)
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
Placebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

Locations

Country Name City State
Argentina Fundacion Respirar (Centro Medico Dra. De Salvo) Ciudad Autonoma Buenos Aires
Argentina Hospital Britanico de Buenos Aires Ciudad Autonoma Buenos Aires
Argentina Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility Córdoba
Argentina Centro Medico de Enfermedades Respiratorias (CEMER) Florida, Buenos Aires
Argentina Centro de estudios respiratorios Mar Del Plata
Argentina Fundacion Scherbovsky Mendoza
Argentina INSARES Mendoza, Mendoza City
Argentina Investigaciones en Patologias Respiratorias San Miguel de Tucuman
Australia The Queen Elizabeth Hospital Adelaide South Australia
Australia Cairns Base Hospital; Cancer Care Centre Cairns Queensland
Australia Royal Prince Alfred Hospital Camperdown New South Wales
Australia Austin Hospital; Cancer Clinical Trials Centre Melbourne Victoria
Australia Monash Medical Centre; Medicine Melbourne Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Lung Research Queensland Nundah Queensland
Australia The Alfred Hospital Prahan Victoria
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung Klagenfurt
Austria Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie Salzburg
Belgium ULB Hôpital Erasme Brussels
Belgium Cliniques Universitaires Saint-Luc; Pharmacy Bruxelles
Belgium UZ Leuven Leuven
Belgium C. H. U. Sart-Tilman; Laboratory Liège
Belgium CHU UCL Namur / site Godinne Yvoir
Brazil Hospital das Clinicas - UFMG Belo Horizonte MG
Brazil Santa Casa de Misericordia de Porto Alegre Porto Alegre RS
Canada University of Alberta Hospital Edmonton Alberta
Canada Kelowna Respiratory and Allergy Clinic Kelowna British Columbia
Canada Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital Montreal Quebec
Canada McGill University, Montreal Chest Institute; Viral and other Infectious Montreal Quebec
Canada The Rhema Research Institute Owen Sound Ontario
Canada Synergy Respiratory Care Sherwood Park Alberta
Canada Eastern Health - General Hospital St. John's Newfoundland and Labrador
Canada C.I.C. Mauricie Trois-Rivières Quebec
Canada Vancouver General Hospital; Gordon and Leslie Diamond Health Care Vancouver British Columbia
Canada Dr. Syed Anees Medicine Profession Corporation Windsor Ontario
China Peking University Third Hospital Beijing
China China-Japan Friendship Hospital Beijing City
China CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine Beijing City
China Peking Union Medical College Hospital; Pharmacy Beijing City
China Beijing Friendship Hospital Affiliated of Capital University of Medical Science Beijing Shi
China The Second Xiangya Hospital of Central South University Changsha
China The Third Xiangya Hospital Of Central South University Changsha
China Xiangya Hospital Central South University Changsha City
China West China Hospital, Sichuan University Chengdu
China Southern Medical University Nanfang Hospital Guangdong Province Guangzhou City
China The First Affiliated Hospital of Guangzhou Medical University Guangzhou
China The First Affilicated Hospital, Sun Yat-sen University Guangzhou City
China 1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy Hangzhou City
China Inner Mongolia Autonomous Region People's Hospital Hohhot City
China Qilu Hospital of Shandong University Jinan
China The 1st Affiliated Hospital of Nanchang Unversity Nanchang City
China Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing City
China Ningbo First Hospital Ningbo City
China Huadong Hospital Affiliated to Fudan University Shanghai
China Shanghai Pulmonary Hospital Shanghai
China Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai City
China Shengjing Hospital of China Medical University ShenYang
China China Medical University (CMU) First Affiliated Hospital Shenyang City
China Hebei Medical University - The Second Hospital Shijiazhuang City
China Tianjin Medical University General Hospital Tianjin
China Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan City
China Wuxi People's Hospital Wuxi
China Tangdu Hospital, The Fourth Military Medical University; Neurology Department Xi'an City
China Qinghai Provincial People?s Hospital Xining City
China The First Affiliated Hospital of Zhengzhou University Zhengzhou
China Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital Zhengzhou City
Czechia Fakultní Nemocnice Brno Brno
Czechia Fakultni nemocnice Olomouc Olomouc
Czechia Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie Plzen
Czechia Nemocnice Na Bulovce Prague
Czechia Thomayerova nemocnice; Lekarna - pavilon H Praha 4
Czechia Krajská nemocnice T. Bati, a. s. Zlín
Denmark Aarhus Universitetshospital Skejby Aarthus N
Denmark Gentofte Hospital Hellerup
Denmark Odense Universitetshospital Odense C
Finland Turku University Hospital Turku
France Hopital Avicenne Bobigny
France Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche Brest
France Hopital Louis Pradel Bron
France Hospital d Instructions des Armees Percy Clamart
France CHU Dijon Bourgogne Hôpital François Mitterand Dijon
France CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie La Tronche
France Centre Hospitalier Regional Universitaire de Lille Lille
France Servie de Pneumologie et centre de Transplantation Pulmonaire Marseille
France CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique Montpellier
France CHU Nice - Hôpital Pasteur 2 Nice
France European Hospital Georges Pompidou (HEGP) Paris
France Hopital Bichat Claude Bernard; CIC Paris
France Hopital Haut Leveque Pessac
France Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche Reims
France CHU de Rennes - Hopital de Pontchaillo Rennes
France CHU Tours - Hôpital Bretonneau; Pharmacie Tours
Germany Zentralklinik Bad Berka GmbH; Pneumologie Bad Berka
Germany Evang. Lungenklinik Berlin Klinik für Pneumologie Berlin
Germany Universitatsklinikum Essen; Innere Klinik Essen
Germany IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie Frankfurt am Main
Germany Universitatsklinikum Gießen und Marburg GmbH Gießen
Germany Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie Hannover
Germany Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik Heidelberg
Germany Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde Homburg/Saar
Germany Lungenfachklinik Immenhausen Immenhausen
Germany Universitatsklinikum Leipzig; Apotheke Leipzig
Germany IKF Pneumologie Mainz Helix Medical Excellence Center Mainz Mainz
Germany Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup Marburg
Germany Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken Münnerstadt
Germany Krankenhaus Bethanien gGmbH Solingen
Greece Evangelismos Hospital; Department of Critical Care and Pulmonary Services Athens
Greece Attikon University General Hospital Chaidari
Greece University General Hospital of Heraklion Herakleion
Greece University Hospital of Ioannina; Pulmonology Department Ioannina
Greece Hospital is University General Hospital of Larissa Larissa
Greece Athens Medical Center Marousi
Greece University General Hospital of Patras Patras
Greece "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic " Sotiria Athens
Greece General Hospital of Thessaloniki G. Papanikolaou Thessaloniki
Hong Kong Prince of Wales Hospital; Dept. of Medicine & Therapeutics Hong Kong
Hong Kong The University of Hong Kong; Queen Mary Hospital Hong Kong
Hungary Semmelweis University Budapest
Hungary Debreceni Egyetem Debrecen
Hungary Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET Szombathely
Hungary Szent Borbala Korhaz Tatabánya
Hungary Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum Törökbálint
Israel Barzilai Medical Center; Neurology Department Ashkelon
Israel Shamir medical center Be'er Ya'akov
Israel Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute Beer sheva
Israel Bnai Zion Medical Center; Internal Medicine Haifa
Israel Carmel Medical Center; Obstetrics and Gynecology Haifa
Israel Rambam Health Care Campus Haifa
Israel Edith Wolfson Medical Center Holon
Israel Hadassah Medical Center Jerusalem
Israel Shaare Zedek Medical Center; Nrphrology Dept. Jerusalem
Israel Meir Medical Center Kfar- Saba
Israel Rabin Medical Center Petach Tiqwa
Israel The Chaim Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rehovot
Israel Tel-Aviv Sourasky Medical Center; Department of Pulmonary Tel Aviv
Italy Azienda Ospedaliera Papa Giovanni XXIII Bergamo Abruzzo
Italy Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Catania Sicilia
Italy AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2 Firenze Toscana
Italy Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia Foggia Puglia
Italy Ospedale Morgagni Pierantoni; Patologia clinica Forlì Emilia-Romagna
Italy "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" " Garbagnate Milanese Lombardia
Italy Asst Santi Paolo E Carlo Milano Lombardia
Italy Ospedale San Giuseppe; U.O. di Pneumologia Milano Lombardia
Italy A.O.U. Policlinico di Modena Modena Emilia-Romagna
Italy Ospedale San Gerardo Monza Lombardia
Italy AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico Napoli Campania
Italy Azienda Ospedaliera Dei Colli Napoli Campania
Italy Azienda Ospedaliera Universitaria Federico II Napoli Campania
Italy Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche Napoli Campania
Italy A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone Orbassano (to) Piemonte
Italy Ospedale di Ostuni - Pneumologia Ostuni Puglia
Italy Azienda Ospedale Università Di Padova; Clinica Pneumologica Padova Veneto
Italy Az. Osp. Univ. P. Giaccone; UOC di Pneumologia Palermo Sicilia
Italy Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia Palermo Sicilia
Italy Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia Pavia Lombardia
Italy Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia Rome Lazio
Italy Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio Rome Lazio
Italy A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale Sassari Sardegna
Italy A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche Siena Toscana
Italy Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette Torino Piemonte
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti Torrette Di Ancona Marche
Italy University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center Treviso Veneto
Italy Azienda Sanitaria Universitaria Integrata di Trieste Trieste Friuli-Venezia Giulia
Japan Nagoya University Hospital Aichi
Japan Chiba University Hospital Chiba
Japan Fukuoka University Hospital Fukuoka
Japan National Hospital Organization Kyushu Medical Center Fukuoka
Japan Kobe City Medical Center General Hospital Hyogo
Japan National Hospital Organization Himeji Medical Center Hyogo
Japan Kameda Medical Center Kamogawa
Japan Kanagawa Cardiovascular and Respiratory Center Kanagawa
Japan Nippon Medical School Musashi Kosugi Hospital Kawasaki-Shi
Japan Saiseikai Kumamoto Hospital Kumamoto-Shi
Japan Nagasaki University Hospital Nagasaki
Japan National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research Naka-gun
Japan Kurashiki Central Hospital Okayama
Japan National Hospital Organization Kinki-Chuo Chest Medical Center Sakai-shi
Japan Tosei General Hospital Seto-shi
Japan Tenri Hospital Tenri-Shi
Japan Jichi Medical University Hospital Tochigi
Japan Tokushima University Hospital Tokushima
Japan Center Hospital of the National Center for Global Health and Medicine Tokyo
Japan Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology Tokyo
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon-si,
Korea, Republic of The Catholic University of Korea Bucheon St. Mary's Hospital Gyeonggi-do
Korea, Republic of Gacheon University Gil Medical Center Namdong-gu
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital (SNUH) - Medical Oncology Center Seoul
Korea, Republic of Soonchunhyang University Hospital Seoul
Korea, Republic of The Catholic University of Korea Seoul St. Mary?s Hospital Seoul
Korea, Republic of The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology Seoul
Mexico Unidad de Investigacion CIMA SC Chihuahua
Mexico INER- Instituto Nacional de Enfermedades Respiratorias"Ismae Ciudad de México Mexico CITY (federal District)
Mexico Centro Respiratorio de México Mexico Mexico CITY (federal District)
Mexico CICC Morelia Morelia
Mexico Unidad Médica para la Salud Integral UMSI San Nicolás de Los Garza Nuevo LEON
Netherlands VU Medisch Centrum Amsterdam
Netherlands Sint Antonius Ziekenhuis, locatie Nieuwegein Nieuwegein
Netherlands Erasmus Medisch Centrum Rotterdam
New Zealand Auckland City Hospital Auckland
New Zealand NZ Respiratory & Sleep Institute Auckland
New Zealand University of Otago, Christchurch Christchurch
New Zealand Waikato Hospital; Gastro Research Hamilton
New Zealand Tauranga Hospital Tauranga
Norway Helse Bergen HF Haukeland universitetssykehus Bergen
Norway Akershus universitetssykehus Lørenskog
Norway Oslo University Hospital HF, Rikshospitalet Oslo
Poland Centrum Medycyny Oddechowej Mroz sp. j. Bia?ystok
Poland Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz
Poland Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii Lodz
Portugal Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E) Braga
Portugal Centro Hospitalar Algarve Faro
Portugal Hospital Senhora da Oliveira ? Guimarães, E.P.E Guimaraes
Portugal Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente Lisboa
Portugal Centro Hospitalar do Porto - Hospital de Santo António Porto
Portugal Hospital de Santa Luzia Porto
Portugal Hospital de Sao Joao; Centro de Investigacao Porto
Portugal CHVNG/E_Unidade 1; Servico de Pneumologia Vila Nova de Gaia
Singapore Singapore General Hospital Singapore
Singapore Tan Tock Seng Hospital; Oncology Singapore
South Africa University of Cape Town Lung Institute; Lung Clinical Research Cape Town
South Africa Vergelegen Medi-Clinic Somerset West
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia Barcelona
Spain Hospital Germans Trias i Pujol Barcelona
Spain Vall d?Hebron Institute of Oncology (VHIO), Barcelona Barcelona
Spain Hospital Universitario del Henares Coslada Madrid
Spain Hospital Galdakao-Usansolo Galdakao Vizcaya
Spain Hospital Virgen de las Nieves; Servicio de Neumologia Granada
Spain Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona
Spain Clínica Universidad de Navarra ? Madrid Madrid
Spain Hosp. Clinico San Carlos Madrid
Spain Hospital Ramón y Cajal;Servicio de Neumología Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario Fundacion Jimenez Diaz. Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Madrid
Spain Hospital Clinico Universitario Virgen de la Victoria Malaga
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Universidad de Navarra - Clinica Universitaria de Navarra (CUN) Pamplona Navarra
Spain Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón Madrid
Spain Hospital Universitario de Canarias S. Cristobal De La Laguna Tenerife
Spain Parc Taulí Sabadell Hospital Universitari Sabadell Barcelona
Spain Hospital Clinico Universitario de Salamanca Salamanca
Spain Hospital Universitario Marques de Valdecilla Santander Cantabria
Spain Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario Santiago de Compostela LA Coruña
Spain Hospital Universitario Virgen del Rocio Sevilla
Spain Hospital Arnau de Vilanova (Valencia) Valencia
Spain Hospital Clinico Universitario de Valencia Valencia
Spain Hospital Universitari i Politecnic La Fe de Valencia Valencia
Spain Hospital Txagorritxu Vitoria-Gasteiz Alava
Sweden Skånes universitetssjukhus Malmö Malmö
Switzerland Inselspital Bern Universitätsklinik für Pneumologie Bern
Switzerland Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales) Neuchâtel
Taiwan Buddhist Tzu Chi Dalin General Hospital; Rheumatology Chia-yi
Taiwan Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital Kaoshiung City
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Far Eastern Memorial Hospital; Department of Clinical Pathology Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Veterans General Hospital - Taichung Xitun Dist.
Turkey Istanbul Universitesi Onkoloji Enstitüsü Hastanesi ?stanbul
Turkey Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali Adana
Turkey Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara
Turkey Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi Bursa
Turkey Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep
Turkey Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari Istanbul
Turkey Dokuz Eylul University Faculty of Medicine; Chest Diseases Izmir
Turkey Ege Universitesi Tip Fakultesi Hastanesi Izmir
Turkey Erciyes Üniversitesi T?p Fakültesi Kayseri
Turkey Kocaeli Universitesi Tip Fakultesi Kocaeli
Turkey Marmara Universitesi Hastanesi Marmara University Hospital Maltepe
Turkey Mersin Üniversitesi Tip Fakültesi Mersin
Turkey Akdeniz University Faculty of Medicine Department of Pulmonology Muratpasa/Antalya
Turkey Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine) Sariyer
Ukraine Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council Dnipro Katerynoslav Governorate
Ukraine National Academy of Medical Science of Ukraine (NAMS); NRCRM Kyiv KIEV Governorate
Ukraine Yanovskyy Inst of Phth. & Pulm; Clinical-functional Kyiv
United Kingdom Edinburgh Royal Infirmary; Respiratory Department Edinburgh
United Kingdom Royal Brompton Hospital; Respiratory Department London
United Kingdom Manchester University NHS Foundation Trust - Wythenshawe Hospital Manchester
United Kingdom North Manchester General Hospital Manchester
United States Emory University Atlanta Georgia
United States University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) Aurora Colorado
United States Piedmont Healthcare Pulmonary and Critical Care Research Austell Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Brigham & Women'S Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Meris Clinical Research Brandon Florida
United States Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration Celebration Florida
United States Medical University of South Carolina Hospital Charleston South Carolina
United States American Health Research Inc. Charlotte North Carolina
United States The Lung Research Center Chesterfield Missouri
United States University of Cincinnati Cancer Institute Cincinnati Ohio
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States SleepMed of South Carolina Columbia South Carolina
United States Horizon Clinical Research Group Cypress Texas
United States Cardiopulmonary Research Science and Technology Institute Dallas Texas
United States University of Texas Southwestern Medical Center; Heart and Lung Clinic Dallas Texas
United States Advanced Pulmonary & Sleep Research Institute of Florida Daytona Beach Florida
United States National Jewish Health Medical Center Denver Colorado
United States Duke University Medical Center Durham North Carolina
United States NorthShore University HealthSystem Evanston Illinois
United States Inova Fairfax Hospital/IHVI; Cardiology Falls Church Virginia
United States Malcom Randall VA Medical Center Gainesville Florida
United States University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine Gainesville Florida
United States University of Texas Medical Branch; Cardiology Department Galveston Texas
United States Pulmonix Research Greensboro North Carolina
United States Indiana Univ School of Med Indianapolis Indiana
United States University of Iowa Hospitals and Clinics; Investigational Drug Services Iowa City Iowa
United States University of Florida Health Pulmonology - Jacksonville Jacksonville Florida
United States University of Kansas Medical Center Kansas City Kansas
United States DCOL Center for Clinical Research Longview Texas
United States University of Louisville Health Sciences Center Louisville Kentucky
United States Advanced Pulmonary Research Institute Loxahatchee Groves Florida
United States University of Wisconsin-Madison Madison Wisconsin
United States Metroplex Pulmonology & Sleep Center McKinney Texas
United States San Marcus Research Clinic Inc. Miami Florida
United States University of Minnesota Medical Center Minneapolis Minnesota
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale New Haven Hospital New Haven Connecticut
United States Lenox Hill Hospital New York New York
United States Lowcountry Lung and Critical Care North Charleston South Carolina
United States Renstar Medical Research Ocala Florida
United States University of Nebraska Medical Center Omaha Nebraska
United States UC Irvine Medical Center Orange California
United States Central Florida Pulmonary Group, PA Orlando Florida
United States Stanford Hospital and Clinics Palo Alto California
United States Jefferson University Physicians (JUP) - Jefferson Pulmonary Philadelphia Pennsylvania
United States Temple University Medical Center Philadelphia Pennsylvania
United States Banner University Medical Center Phoenix; Main Pharmacy Phoenix Arizona
United States Lovelace Scientific Resources, Inc. Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Rochester Minnesota
United States University of California Davis Sacramento California
United States Covenant Medical Center - Cooper Saginaw Michigan
United States Washington University Saint Louis Missouri
United States University Of Utah Hosp & Clin; Investigational Pharmacy Salt Lake City Utah
United States Audie L. Murphy VA Hospital, STVHCS San Antonio Texas
United States Inst. of Healthcare Assessment, Inc. San Diego California
United States UCSF Medical Center San Francisco California
United States Paloma Medical Group San Juan Capistrano California
United States William Sansum Diabetes Center Santa Barbara California
United States Sarasota Memorial Health Care System; Cancer Research Program Sarasota Florida
United States Spartanburg Medical Center Spartanburg South Carolina
United States Pulmonary & Allergy Associates Summit New Jersey
United States University of South Florida Tampa Florida
United States Mercy St. Vincent Medical Center Toledo Ohio
United States Georgetown University Medical Center Washington District of Columbia
United States Integral ? Clinical Trial Solutions Weston Florida
United States PMG Research of Wilmington Wilmington North Carolina
United States Clinical Site Partners Orlando Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Absolute Change in Forced Vital Capacity (FVC [mL]) From Baseline up to Week 52
Secondary Absolute Change in 6-minute Walk Distance (6MWD) From Baseline up to Week 52
Secondary Absolute Change in FVC% Predicted From Baseline up to Week 52
Secondary Time to Disease Progression From Baseline up to 2.5 years
Secondary Time to First Respiratory-related Hospitalizations From Baseline up to 2.5 years
Secondary Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) From Baseline up to Week 52
Secondary Change in St. George Respiratory Questionnaire (SGRQ) Total Score From Baseline up to Week 52
Secondary Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) From Baseline up to 2.5 years
Secondary Change in Carbon Monoxide Diffusing Capacity (DLCO) From Baseline up to Week 52
Secondary Survival Survivial is measured by all-cause mortality From Baseline up to 2.5 years
Secondary Percentage of Participants with Adverse Events (AEs) From Baseline up to 2.5 years
Secondary Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest From Baseline up to 2.5 years
Secondary Percentage of Participants Permanently Discontinuing Study Treatment due to AEs From Baseline up to 2.5 years
Secondary Change from Baseline in Targeted Clinical Laboratory Test Results From Baseline up to 2.5 years
Secondary Plasma Concentrations of PRM-151 Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
Secondary Prevalence of Anti-drug Antibodies (ADAs) at Baseline Day 1
Secondary Percentage of Participants with ADAs During the Study Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56
See also
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