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

A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Study Overview

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

Detailed Description

This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 3

Contacts and Locations

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
  • Derqui-Pilar, Argentina, B1629ODT
    • Hospital Universitario Austral
  • 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
  • Rosario, Argentina, S2000DEJ
    • Instituto Medico de la Fundacion Estudios Clinicos
  • San Miguel de Tucuman, Argentina, T4000IAR
    • Investigaciones en Patologias 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
  • Victoria
    • Melbourne, Victoria, Australia, 3186
      • Monash Medical Centre; Medicine
    • Prahan, Victoria, Australia, 3181
      • The Alfred Hospital
• 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
• Canada
  • Alberta
    • Sherwood Park, Alberta, Canada, T8H ON2
      • Synergy Respiratory Care
  • British Columbia
    • Kelowna, British Columbia, Canada, V1W 1V3
      • Kelowna Respiratory and Allergy Clinic
  • Ontario
    • Owen Sound, Ontario, Canada, N4K 6M9
      • The Rhema Research Institute
    • Windsor, Ontario, Canada, N8X 1T3
      • Dr. Syed Anees Medicine Profession Corporation
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8T 7A1
      • C.I.C. Mauricie
• China
  • 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
  • ShenYang, China, 110004
    • Shengjing Hospital Of China Medical University
  • 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
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University
• Czechia
  • Brno, Czechia, 613 00
    • Fakultni nemocnice Brno
  • Hradec Kralove, Czechia, 500 05
    • Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie
  • Praha 4, Czechia, 140 00
    • Thomayerova nemocnice; Lekarna - pavilon H
  • Zlin, Czechia, 760 01
    • Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni
• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • Odense C, Denmark, 5000
    • Odense Universitetshospital
• France
  • Bobigny, France, 93000
    • Hôpital Avicenne
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
  • Bron, France, 69677
    • Hôpital Louis Pradel
  • CHU Hopitaux De Bordeaux, France, 33000
    • CHU Hopitaux de Bordeaux
  • 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
  • Nice, France, 06000
    • CHU Nice - Hôpital Pasteur 2
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie
  • Reims, France, 51092
    • Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes
  • Tours, France, 37044
    • CHU Tours - Hopital Bretonneau
• Germany
  • Berlin, Germany, 13125
    • Evang. Lungenklinik Berlin Klinik für Pneumologie
  • Heidelberg, Germany, 69120
    • Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • 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, 10676
    • Evangelismos Hospital; Endocrinology, Diabetes & Metabolism
  • 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
  • Marousi, Greece, 151 25
    • Athens Medical Center
  • Mezourlo, Greece, 41110
    • University of Thessaly Faculty of Medicine
  • 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
  • Holon, Israel, 5822012
    • Edith Wolfson Medical Center
  • Jerusalem, Israel, 9103102
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112000
    • Hadassah Medical Center
  • 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, 6423906
    • Tel Aviv Sourasky Medical Center; Department of Neurology
• 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
      • "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "
  • Emilia-Romagna
    • Forlì, Emilia-Romagna, Italy, 47100
      • Ospedale Morgagni Pierantoni; Patologia clinica
    • Modena, Emilia-Romagna, Italy, 40124
      • A.O.U. Policlinico di Modena
  • 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
    • 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
  • Puglia
    • Foggia, Puglia, Italy, 71122
      • Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
  • 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 Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1
    • 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
  • 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, 13620
    • 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
• Mexico
  • Chihuahua, Mexico, 31200
    • Unidad de Investigacion CIMA SC
  • Mexico, Mexico, 14050
    • Centro Respiratorio de México
  • Mexico, Mexico, 14080
    • INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
  • Morelia, Mexico
    • CICC Morelia
  • Nuevo LEON
    • San Nicolás de Los Garza, Nuevo LEON, Mexico, 66465
      • Unidad Médica para la Salud Integral UMSI
• Netherlands
  • 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, 5021
    • Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen
  • 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
    • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
  • Guimarães, Portugal, 4835-044
    • Centro Hospitalar do Alto Ave; EPE
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar Universitário Lisboa Norte - Hospital Pulido Valente
  • 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
  • Singapore, Singapore, 117599
    • National University Hospital
• 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 I Provincial
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Granada, Spain, 18014
    • Hospital Virgen de las Nieves; Servicio de Neumologia
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Madrid, Spain, 28034
    • Hospital Ramón y Cajal;Servicio de Neumología
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Aparato Digestivo
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra ; Servicio de Farmacia
  • Madrid, Spain, 28029
    • Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Fundacion Jimenez Diaz-UTE
  • Malaga, Spain, 29010
    • Hospital Clinico Universitario Virgen de la Victoria
  • Salamanca, Spain, 37007
    • Hospital Clinico Universitario de Salamanca
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Alava
    • Vitoria, Alava, Spain, 01009
      • HUA - Txagorritxu
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Hospital Univ. Central de Asturias
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Sanitaria Parc Taulí; Servicio de Neurología
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marques de Valdecilla
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • CHUS ? H. Clinico U. de Santiago
  • Madrid
    • Coslada, Madrid, Spain, 28850
      • Hospital Universitario del Henares
  • Vizcaya
    • Galdakao, Vizcaya, Spain, 48960
      • Hospital Galdakao-Usansolo
• 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, 27310
    • Gaziantep Universitesi Tip Fakultesi
  • Istanbul, Turkey, 34020
    • Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi
  • Izmir, Turkey, 35100
    • Ege Universitesi Tip Fakultesi Hastanesi
  • Izmir, Turkey, 35340
    • Dokuz Eylul University Faculty of Medicine; Chest Diseases
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi
  • Maltepe, Turkey, 34854
    • Marmara Universitesi Hastanesi Marmara University Hospital
  • Melikgazi/Kayser, Turkey, 38039
    • Eriyes universitesi T?p Fakultesi Hastanesi
  • Mersin, Turkey, 33110
    • Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi
  • 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)
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • 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
  • Colorado
    • 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
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Pulmonology - Jacksonville
    • Loxahatchee Groves, Florida, United States, 33470-9216
      • Advanced Pulmonary Research Institute
    • Sarasota, Florida, United States, 34239
      • Sarasota County Public Hospital
    • Wesley Chapel, Florida, United States, 33544
      • Renstar Medical Research
    • Winter Park, Florida, United States, 32789
      • Florida Pulmonary Research Institute, LLC
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore University HealthSystem
  • 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
  • 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 York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • North Carolina
    • Greensboro, North Carolina, United States, 27403-1127
      • Pulmonix Research
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson University Physicians (JUP) - Jefferson Pulmonary
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • 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
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch at Galveston
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonology & Sleep Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University Of Utah Hosp & Clin; Investigational Pharmacy
  • Virginia
    • Falls Church, Virginia, United States, 22031
      • Inova Fairfax Hospital
    • Richmond, Virginia, United States, 23219-1901
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria:

• Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
• History of smoking within 3 months prior to the first visit in the OLE.
• History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
• History of severe allergic reaction or anaphylactic reaction to PRM-151.
• Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
• Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
• Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PRM-151; Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.

Drug: PRM-151 (Zinpentraxin Alfa); Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks. Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo.; Other Names: Zinpentraxin Alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adverse Events (AE)	Severity will be determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]).	From baseline until 8 weeks after the final dose
Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest		From baseline until 8 weeks after the final dose
Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs		From baseline until 8 weeks after the final dose
Change from Baseline in Targeted Clinical Laboratory Test Results		From baseline until 8 weeks after the final dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annual Rate of Change in Forced Vital Capacity (FVC) (mL)		From baseline until study completion (up tp 4 years)
Annual Rate of Change in 6-Minute Walk Distance (6MWD)		From baseline until study completion (up tp 4 years)
Annual Rate of Change in FVC% Predicted		From baseline until study completion (up tp 4 years)
Annual Rate of Change in Carbon Monoxide Diffusing Capacity (DLCO)		From baseline until study completion (up tp 4 years)
Time to Disease Progression	Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death	From the time of randomization until disease progression or death (up tp 4 years)
Survival		Every 6 Months and at study completion (up to 4 years)
IPF-related Mortality		Every 6 Months and at study completion (up to 4 years)
Respiratory-related Mortality		Every 6 Months and at study completion (up to 4 years)
Plasma Concentrations of PRM-151 at Specified Timepoints		Days 1, 3 and 5, Weeks 4, 12 and 24
Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline		Baseline (Day 1)
Percentage of Participants with ADAs During the Study		Weeks 4, 12 and 24

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Actual): February 10, 2023
• Study Completion (Actual): February 10, 2023

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 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: WA42294; 2020-001429-30 (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