A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis (STARSCAPE)

A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis

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).

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: PRM-151 (Zinpentraxin Alfa); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 665
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: WA42293 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
    • Hospital Británico de Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina, C1426ABP
    • Fundacion Respirar (Centro Medico Dra. De Salvo)
  • Córdoba, Argentina, X5003DCE
    • Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
  • Florida, Buenos Aires, Argentina, B1602DQD
    • Centro Medico de Enfermedades Respiratorias (CEMER)
  • Mar Del Plata, Argentina, B7600CLK
    • Centro de estudios respiratorios
  • Mendoza, Argentina, M5500AYB
    • Fundacion Scherbovsky
  • Mendoza, Mendoza City, Argentina, M5500CCG
    • INSARES
  • San Miguel de Tucuman, Argentina, T4000IAR
    • Investigaciones en Patologías Respiratorias
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Queensland
    • Cairns, Queensland, Australia, 4870
      • Cairns Base Hospital; Cancer Care Centre
    • Nundah, Queensland, Australia, 4101
      • Lung Research Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Hospital; Cancer Clinical Trials Centre
    • Melbourne, Victoria, Australia, 3186
      • Monash Medical Centre; Medicine
    • Prahan, Victoria, Australia, 3181
      • The Alfred Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
• Belgium
  • Brussels, Belgium, 1070
    • ULB Hopital Erasme
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc; Pharmacy
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Liège, Belgium, 4000
    • C. H. U. Sart-Tilman; Laboratory
  • Yvoir, Belgium, B5530
    • CHU UCL Namur / site Godinne
• Brazil
  • MG
    • Belo Horizonte, MG, Brazil, 31270-901
      • Hospital das Clinicas - UFMG
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Santa Casa de Misericórdia de Porto Alegre
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z1
      • University of Alberta Hospital
    • Sherwood Park, Alberta, Canada, T8H ON2
      • Synergy Respiratory Care
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 1V3
      • Kelowna Respiratory and Allergy Clinic
    • Vancouver, British Columbia, Canada, V5Z 1L7
      • Vancouver General Hospital; Gordon and Leslie Diamond Health Care
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Eastern Health - General Hospital
  • Ontario
    • Owen Sound, Ontario, Canada, N4K 6M9
      • The Rhema Research Institute
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Syed Anees Medicine Profession Corporation
  • Quebec
    • Montreal, Quebec, Canada, H2X 1R9
      • Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
    • Montreal, Quebec, Canada, H2X2P4
      • McGill University, Montreal Chest Institute; Viral and other Infectious
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • C.I.C. Mauricie
• China
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Beijing City, China, 100029
    • China-Japan Friendship Hospital
  • Beijing City, China, 100020
    • CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine
  • Beijing City, China, 100730
    • Peking Union Medical College Hospital; Pharmacy
  • Beijing Shi, China, 100050
    • Beijing Friendship Hospital Affiliated of Capital University of Medical Science
  • Changsha, China, 410013
    • The Third Xiangya Hospital of Central South University
  • Changsha, China, 410011
    • The Second Xiangya Hospital of Central South University
  • Changsha City, China, 410008
    • Xiangya Hospital Central South University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Guangdong Province Guangzhou City, China, 510515
    • Southern Medical University Nanfang Hospital
  • Guangzhou, China, 510120
    • The First Affiliated Hospital of Guangzhou Medical University
  • Guangzhou City, China, 510080
    • The First Affilicated Hospital, Sun Yat-sen University
  • Hangzhou City, China, 310003
    • 1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy
  • Hohhot City, China, 010011
    • Inner Mongolia Autonomous Region People's Hospital
  • Jinan, China, 250012
    • Qilu Hospital of Shandong University
  • Nanchang City, China, 330006
    • The 1st Affiliated Hospital of Nanchang Unversity
  • Nanjing City, China, 210008
    • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
  • Ningbo City, China, 315010
    • Ningbo First Hospital
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital
  • Shanghai, China, 200040
    • Huadong Hospital Affiliated To Fudan University
  • Shanghai City, China, 200025
    • Ruijin Hospital Shanghai Jiaotong University School of Medicine
  • ShenYang, China, 110004
    • Shengjing Hospital of China Medical University
  • Shenyang City, China, 110001
    • China Medical University (CMU) First Affiliated Hospital
  • Shijiazhuang City, China, 050004
    • Hebei Medical University - The Second Hospital
  • Tianjin, China, 300052
    • Tianjin Medical University General Hospital
  • Wuhan City, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Wuxi, China, 214023
    • Wuxi People's Hospital
  • Xi'an City, China, 710038
    • Tangdu Hospital, The Fourth Military Medical University; Neurology Department
  • Xining City, China, 810007
    • Qinghai Provincial People?s Hospital
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University
  • Zhengzhou City, China, 450000
    • Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital
• Czechia
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Plzen, Czechia, 305 99
    • Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie
  • Prague, Czechia, 180 01
    • Nemocnice Na Bulovce
  • Praha 4, Czechia, 140 00
    • Thomayerova nemocnice; Lekarna - pavilon H
  • Zlín, Czechia, 762 75
    • Krajská nemocnice T. Bati, a. s.
• Denmark
  • Aarthus N, Denmark, 8200
    • Aarhus Universitetshospital Skejby
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• Finland
  • Turku, Finland, 20521
    • Turku University Hospital
• France
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
  • Bron, France, 69677
    • Hopital Louis Pradel
  • Clamart, France, 92141
    • Hospital d Instructions des Armees Percy
  • Dijon, France, 21000
    • CHU Dijon Bourgogne Hôpital François Mitterand
  • La Tronche, France, 38700
    • CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
  • Lille, France
    • Centre Hospitalier Régional Universitaire de Lille
  • Marseille, France, 13354
    • Servie de Pneumologie et centre de Transplantation Pulmonaire
  • Montpellier, France, 34295
    • CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
  • Nice, France, 06000
    • CHU Nice - Hôpital Pasteur 2
  • Paris, France, 75877
    • Hopital Bichat Claude Bernard; CIC
  • Paris, France, 75908
    • European Hospital Georges Pompidou (HEGP)
  • Pessac, France, 33604
    • Hopital Haut Leveque
  • Reims, France, 51092
    • Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
  • Rennes, France, 35033
    • CHU de Rennes - Hopital de Pontchaillo
  • Tours, France, 37044
    • CHU Tours - Hôpital Bretonneau; Pharmacie
• Germany
  • Bad Berka, Germany, 99437
    • Zentralklinik Bad Berka GmbH; Pneumologie
  • Berlin, Germany, 13125
    • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Essen, Germany, 45122
    • Universitatsklinikum Essen; Innere Klinik
  • Frankfurt am Main, Germany, 60596
    • IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
  • Gießen, Germany, 35385
    • Universitätsklinikum Gießen und Marburg GmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie
  • Heidelberg, Germany, 69120
    • Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
  • Homburg/Saar, Germany, 66424
    • Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • Leipzig, Germany, 04103
    • Universitatsklinikum Leipzig; Apotheke
  • Mainz, Germany, 55128
    • IKF Pneumologie Mainz Helix Medical Excellence Center Mainz
  • Marburg, Germany, 35037
    • Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
  • Münnerstadt, Germany, 97702
    • Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
  • Solingen, Germany, 42699
    • Krankenhaus Bethanien gGmbH
• Greece
  • Athens, Greece, 106 76
    • Evangelismos Hospital; Department of Critical Care and Pulmonary Services
  • Chaidari, Greece, 124 62
    • Attikon University General Hospital
  • Herakleion, Greece, 711 10
    • University General Hospital of Heraklion
  • Ioannina, Greece, 455 00
    • University Hospital of Ioannina; Pulmonology Department
  • Larissa, Greece, 41110
    • Hospital is University General Hospital of Larissa
  • Marousi, Greece, 151 25
    • Athens Medical Center
  • Patras, Greece, 265 00
    • University General Hospital of Patras
  • Sotiria Athens, Greece, 115 27
    • "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki G. Papanikolaou
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital; Dept. of Medicine & Therapeutics
  • Hong Kong, Hong Kong
    • The University of Hong Kong; Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1081
    • Semmelweis University
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem
  • Szombathely, Hungary, 9700
    • Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
  • Tatabánya, Hungary, 2800
    • Szent Borbala Korhaz
  • Törökbálint, Hungary, 2045
    • Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center; Neurology Department
  • Be'er Ya'akov, Israel, 0070300
    • Shamir Medical Center
  • Beer sheva, Israel, 8410101
    • Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
  • Haifa, Israel, 3109600
    • Rambam Health Care Campus
  • Haifa, Israel, 3339419
    • Bnai Zion Medical Center; Internal Medicine
  • Haifa, Israel, 34362
    • Carmel Medical Center; Obstetrics and Gynecology
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center; Nrphrology Dept.
  • Kfar- Saba, Israel, 4428164
    • Meir Medical Center
  • Petach Tiqwa, Israel, 4941492
    • Rabin Medical Center
  • Ramat Gan, Israel, 5211401
    • The Chaim Sheba Medical Center
  • Rehovot, Israel, 7610001
    • Kaplan Medical Center
  • Tel Aviv, Israel, 64239
    • Tel-Aviv Sourasky Medical Center; Department of Pulmonary
• Italy
  • Abruzzo
    • Bergamo, Abruzzo, Italy, 24060
      • Azienda Ospedaliera Papa Giovanni XXIII
  • Campania
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera Universitaria Federico II
    • Napoli, Campania, Italy, 80131
      • AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
    • Napoli, Campania, Italy, 80131
      • Azienda Ospedaliera dei Colli
    • Napoli, Campania, Italy, 80131
      • Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
  • Emilia-Romagna
    • Forlì, Emilia-Romagna, Italy, 47100
      • Ospedale Morgagni Pierantoni; Patologia clinica
    • Modena, Emilia-Romagna, Italy, 40124
      • A.O.U. Policlinico di Modena
  • Friuli-Venezia Giulia
    • Trieste, Friuli-Venezia Giulia, Italy, 34125
      • Azienda Sanitaria Universitaria Integrata di Trieste
  • Lazio
    • Rome, Lazio, Italy, 00133
      • Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
  • Lombardia
    • Garbagnate Milanese, Lombardia, Italy
      • "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "
    • Milano, Lombardia, Italy, 20142
      • ASST Santi Paolo e Carlo
    • Milano, Lombardia, Italy, 20123
      • Ospedale San Giuseppe; U.O. di Pneumologia
    • Monza, Lombardia, Italy, 20900
      • Ospedale San Gerardo
    • Pavia, Lombardia, Italy, 27100
      • Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
  • Marche
    • Torrette Di Ancona, Marche, Italy, 60126
      • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Piemonte
    • Orbassano (to), Piemonte, Italy, 10043
      • A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
    • Torino, Piemonte, Italy, 10026
      • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
  • Puglia
    • Foggia, Puglia, Italy, 71122
      • Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
    • Ostuni, Puglia, Italy, 72017
      • Ospedale di Ostuni - Pneumologia
  • Sardegna
    • Sassari, Sardegna, Italy, 07100
      • A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
    • Palermo, Sicilia, Italy, 90127
      • Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
    • Palermo, Sicilia, Italy, 90127
      • Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
    • Siena, Toscana, Italy, 53100
      • A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Azienda Ospedale Università Di Padova; Clinica Pneumologica
    • Treviso, Veneto, Italy, 31100
      • University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
• Japan
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Hyogo, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Hyogo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Kamogawa, Japan, 296-0041
    • Kameda Medical Center
  • Kanagawa, Japan, 236-0051
    • Kanagawa Cardiovascular and Respiratory Center
  • Kawasaki-Shi, Japan
    • Nippon Medical School Musashi Kosugi Hospital
  • Kumamoto-Shi, Japan, 861-4101
    • Saiseikai Kumamoto Hospital
  • Nagasaki, Japan, 852-8501
    • Nagasaki University Hospital
  • Naka-gun, Japan, 319-1113
    • National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
  • Okayama, Japan, 710-8602
    • Kurashiki Central Hospital
  • Sakai-shi, Japan, 591-8555
    • National Hospital Organization Kinki-Chuo Chest Medical Center
  • Seto-shi, Japan, 489-8642
    • Tosei General Hospital
  • Tenri-Shi, Japan, 632-8552
    • Tenri Hospital
  • Tochigi, Japan, 329-0498
    • Jichi Medical University Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 113-0034
    • Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
  • Tokyo, Japan, 162-0052
    • Center Hospital of the National Center for Global Health and Medicine
• Korea, Republic of
  • Bucheon-si,, Korea, Republic of, 420-767
    • Soon Chun Hyang University Hospital Bucheon
  • Gyeonggi-do, Korea, Republic of, 14662
    • The Catholic University Of Korea Bucheon St. Mary's Hospital
  • Namdong-gu, Korea, Republic of, 21565
    • Gacheon University Gil Medical Center
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 04401
    • Soonchunhyang university hospital
  • Seoul, Korea, Republic of, (0)7345
    • The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital (SNUH) - Medical Oncology Center
  • Seoul, Korea, Republic of, 6591
    • The Catholic University of Korea Seoul St. Mary?s Hospital
• Mexico
  • Chihuahua, Mexico, 31200
    • Unidad de Investigacion CIMA SC
  • Morelia, Mexico
    • CICC Morelia
  • Mexico CITY (federal District)
    • Ciudad de México, Mexico CITY (federal District), Mexico, 14080
      • INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
    • Mexico, Mexico CITY (federal District), Mexico, 14050
      • Centro Respiratorio de Mexico
  • Nuevo LEON
    • San Nicolás de Los Garza, Nuevo LEON, Mexico, 66465
      • Unidad Médica para la Salud Integral UMSI
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU medisch centrum
  • Nieuwegein, Netherlands, 3430 EM
    • Sint Antonius Ziekenhuis, locatie Nieuwegein
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus Medisch Centrum
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Auckland, New Zealand, 1051
    • NZ Respiratory & Sleep Institute
  • Christchurch, New Zealand, 8011
    • University of Otago, Christchurch
  • Hamilton, New Zealand, 3240
    • Waikato Hospital; Gastro Research
  • Tauranga, New Zealand, 3143
    • Tauranga Hospital
• Norway
  • Bergen, Norway, 5053
    • Helse Bergen HF Haukeland Universitetssykehus
  • Lørenskog, Norway, 1478
    • Akershus Universitetssykehus
  • Oslo, Norway, 0424
    • Oslo University Hospital HF, Rikshospitalet
• Poland
  • Bia?ystok, Poland, 15-044
    • Centrum Medycyny Oddechowej Mroz sp. j.
  • Bydgoszcz, Poland, 85-312
    • Nasz Lekarz Osrodek Badan Klinicznych
  • Lodz, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
  • Faro, Portugal, 8000-386
    • Centro Hospitalar Algarve
  • Guimaraes, Portugal, 4835-044
    • Hospital Senhora da Oliveira ? Guimaraes, E.P.E
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto - Hospital de Santo Antonio
  • Porto, Portugal, 4200-319
    • Hospital de Sao Joao; Centro de Investigacao
  • Porto, Portugal, 4904-858
    • Hospital de Santa Luzia
  • Vila Nova de Gaia, Portugal, 4434-502
    • CHVNG/E_Unidade 1; Servico de Pneumologia
• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital; Oncology
• South Africa
  • Cape Town, South Africa, 7700
    • University of Cape Town Lung Institute; Lung Clinical Research
  • Somerset West, South Africa, 7130
    • Vergelegen Medi-Clinic
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08035
    • Vall d?Hebron Institute of Oncology (VHIO), Barcelona
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves; Servicio de Neumologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 280146
    • Hospital Universitario La Paz
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal;Servicio de Neumología
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz.
  • Madrid, Spain, 28027
    • Clínica Universidad de Navarra ? Madrid
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe de Valencia
  • Valencia, Spain, 46015
    • Hospital Arnau de Vilanova (Valencia)
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01009
      • Hospital Txagorritxu
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
    • Sabadell, Barcelona, Spain, 8208
      • Parc Taulí Sabadell Hospital Universitari
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario
  • Madrid
    • Coslada, Madrid, Spain, 28850
      • Hospital Universitario del Henares
    • Majadahonda, Madrid, Spain, 28220
      • Hospital Universitario Puerta de Hierro - Majadahonda
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario QuironSalud Madrid
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
  • Tenerife
    • S. Cristobal De La Laguna, Tenerife, Spain, 38320
      • Hospital Universitario de Canarias
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital Galdakao-Usansolo
• Sweden
  • Malmö, Sweden, 214 28
    • Skånes Universitetssjukhus Malmö
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern Universitätsklinik für Pneumologie
  • Neuchâtel, Switzerland, 2000
    • Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)
• Taiwan
  • Chia-yi, Taiwan, 622
    • Buddhist Tzu Chi Dalin General Hospital; Rheumatology
  • Kaoshiung City, Taiwan, 807
    • Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40447
    • China Medical University Hospital
  • Tainan, Taiwan, 70457
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 220
    • Far Eastern Memorial Hospital; Department of Clinical Pathology
  • Xitun Dist., Taiwan, 40705
    • Veterans General Hospital - Taichung
• Turkey
  • ?stanbul, Turkey, 34093
    • Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
  • Adana, Turkey, 1330
    • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
  • Ankara, Turkey, 06620
    • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
  • Bursa, Turkey, 16059
    • Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
  • Gaziantep, Turkey
    • Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi
  • Istanbul, Turkey, 34020
    • Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
  • Izmir, Turkey, 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Faculty of Medicine; Chest Diseases
  • Kayseri, Turkey, 38039
    • Erciyes Üniversitesi T?p Fakültesi
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Maltepe, Turkey, 34854
    • Marmara Universitesi Hastanesi Marmara University Hospital
  • Mersin, Turkey, 33110
    • Mersin Universitesi Tip Fakultesi
  • Muratpasa/Antalya, Turkey, 07059
    • Akdeniz University Faculty of Medicine Department of Pulmonology
  • Sariyer, Turkey, 34450
    • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
• Ukraine
  • Kyiv, Ukraine, 03680
    • Yanovskyy Inst of Phth. & Pulm; Clinical-functional
  • KIEV Governorate
    • Kyiv, KIEV Governorate, Ukraine, 03115
      • National Academy of Medical Science of Ukraine (NAMS); NRCRM
  • Katerynoslav Governorate
    • Dnipro, Katerynoslav Governorate, Ukraine, 49069
      • Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
• United Kingdom
  • Edinburgh, United Kingdom, EH16 4SA
    • Edinburgh Royal Infirmary; Respiratory Department
  • London, United Kingdom, SW3 6NP
    • Royal Brompton Hospital; Respiratory Department
  • Manchester, United Kingdom, M8 5RB
    • North Manchester General Hospital
  • Manchester, United Kingdom, M23 9LT
    • Manchester University NHS Foundation Trust - Wythenshawe Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix; Main Pharmacy
    • Phoenix, Arizona, United States, 85016
      • Lovelace Scientific Resources, Inc.
  • California
    • Orange, California, United States, 92868
      • UC Irvine Medical Center
    • Palo Alto, California, United States, 94304
      • Stanford Hospital and Clinics
    • Sacramento, California, United States, 95817
      • University of California Davis
    • San Diego, California, United States, 92120
      • Inst. of Healthcare Assessment, Inc.
    • San Francisco, California, United States, 94143-0748
      • UCSF Medical Center
    • San Juan Capistrano, California, United States, 92675
      • Paloma Medical Group
    • Santa Barbara, California, United States, 93105
      • William Sansum Diabetes Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
    • Denver, Colorado, United States, 80045-2541
      • National Jewish Health Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Brandon, Florida, United States, 33511-5719
      • Meris Clinical Research
    • Celebration, Florida, United States, 34747-1818
      • Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
    • Daytona Beach, Florida, United States, 32117
      • Advanced Pulmonary & Sleep Research Institute of Florida
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Center
    • Gainesville, Florida, United States, 32608-3928
      • University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Pulmonology - Jacksonville
    • Loxahatchee Groves, Florida, United States, 33470-9216
      • Advanced Pulmonary Research Institute
    • Miami, Florida, United States, 33014
      • San Marcus Research Clinic Inc.
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary Group, PA
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Health Care System; Cancer Research Program
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • Weston, Florida, United States, 33327
      • Integral ? Clinical Trial Solutions
    • Winter Park, Florida, United States, 32789
      • Clinical Site Partners Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Austell, Georgia, United States, 30106
      • Piedmont Healthcare Pulmonary and Critical Care Research
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University HealthSystem
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univ School of Med
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics; Investigational Drug Services
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Health Sciences Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
  • Michigan
    • Saginaw, Michigan, United States, 48602-5383
      • Covenant Medical Center - Cooper
  • Minnesota
    • Minneapolis, Minnesota, United States, 29425-8911
      • University of Minnesota Medical Center
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic Rochester
  • Missouri
    • Chesterfield, Missouri, United States, 63017-3625
      • The Lung Research Center
    • Saint Louis, Missouri, United States, 63128
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68198-0600
      • University of Nebraska Medical Center
  • New Jersey
    • Summit, New Jersey, United States, 07901-4055
      • Pulmonary & Allergy Associates
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • American Health Research Inc.
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27403-1127
      • Pulmonix Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Cancer Institute
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson University Physicians (JUP) - Jefferson Pulmonary
    • Philadelphia, Pennsylvania, United States, 19140-4105
      • Temple University Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Hospital
    • Columbia, South Carolina, United States, 29201-2953
      • SleepMed of South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Lowcountry Lung and Critical Care
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center
  • Texas
    • Cypress, Texas, United States, 77429
      • Horizon Clinical Research Group
    • Dallas, Texas, United States, 75230
      • Cardiopulmonary Research Science and Technology Institute
    • Dallas, Texas, United States, 75390-8575
      • University of Texas Southwestern Medical Center; Heart and Lung Clinic
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch; Cardiology Department
    • Longview, Texas, United States, 75605-2410
      • DCOL Center for Clinical Research
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonology & Sleep Center
    • San Antonio, Texas, United States, 78229
      • Audie L. Murphy Va Hospital, Stvhcs
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University Of Utah Hosp & Clin; Investigational Pharmacy
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital/IHVI; Cardiology
    • Richmond, Virginia, United States, 23219-1901
      • Virginia Commonwealth University
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRM-151; Participants will receive intravenous (IV) infusions of PRM-151 over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.	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 Comparator: Placebo; Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.	Drug: Placebo; Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute Change in Forced Vital Capacity (FVC [mL])	From Baseline up to Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: WA42293; 2020-000791-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No