AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 3STARSCAPE-OLENCT04594707

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

A Phase 3 study testing PRM-151 (Zinpentraxin Alfa) in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 248 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
PRM-151 (Zinpentraxin Alfa)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
248 sitesin 28 countries
Study dates
30 Aug 2021to 10 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

248 sites in 28 countries.

248 sites in 28 countries

United States40 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Meris Clinical Research

    Brandon, Florida, 33511-5719

  • Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

    Celebration, Florida, 34747-1818

  • The Lung Research Center

    Chesterfield, Missouri, 63017-3625

  • SleepMed of South Carolina

    Columbia, South Carolina, 29201-2953

  • Advanced Pulmonary & Sleep Research Institute of Florida

    Daytona Beach, Florida, 32117

  • National Jewish Health Medical Center

    Denver, Colorado, 80045-2541

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22031

  • University of Texas Medical Branch at Galveston

    Galveston, Texas, 77555

  • Pulmonix Research

    Greensboro, North Carolina, 27403-1127

  • University of Iowa Hospitals and Clinics; Investigational Drug Services

    Iowa City, Iowa, 52242

  • University of Florida Health Pulmonology - Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Louisville Health Sciences Center

    Louisville, Kentucky, 40202

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470-9216

  • Metroplex Pulmonology & Sleep Center

    McKinney, Texas, 75069

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 29425-8911

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Lenox Hill Hospital

    New York, New York, 10075

  • Lowcountry Lung and Critical Care

    North Charleston, South Carolina, 29406

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-0600

  • Jefferson University Physicians (JUP) - Jefferson Pulmonary

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University

    Richmond, Virginia, 23219-1901

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55902

  • University of California Davis

    Sacramento, California, 95817

  • University Of Utah Hosp & Clin; Investigational Pharmacy

    Salt Lake City, Utah, 84132

  • Inst. of Healthcare Assessment, Inc.

    San Diego, California, 92120

  • UCSF Medical Center

    San Francisco, California, 94143-0748

  • Sarasota County Public Hospital

    Sarasota, Florida, 34239

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Washington University

    St Louis, Missouri, 63128

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Renstar Medical Research

    Wesley Chapel, Florida, 33544

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Florida Pulmonary Research Institute, LLC

    Winter Park, Florida, 32789

Other trials in United States

Spain22 sites

  • Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia

    Barcelona, 08025

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario del Henares

    Coslada, Madrid, 28850

  • Hospital Galdakao-Usansolo

    Galdakao, Vizcaya, 48960

  • Hospital Virgen de las Nieves; Servicio de Neumologia

    Granada, 18014

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario de la Princesa; Servicio de Aparato Digestivo

    Madrid, 28006

  • Clinica Universidad de Navarra ; Servicio de Farmacia

    Madrid, 28027

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

    Madrid, 28029

  • Hospital Ramón y Cajal;Servicio de Neumología

    Madrid, 28034

  • Fundacion Jimenez Diaz-UTE

    Madrid, 28040

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Univ. Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Corporació Sanitaria Parc Taulí; Servicio de Neurología

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • CHUS H Clinico U de Santiago

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • HUA - Txagorritxu

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

Italy20 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, Abruzzo, 24060

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

    Catania, Sicily, 95123

  • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

    Florence, Tuscany, 50134

  • Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia

    Foggia, Apulia, 71122

  • Ospedale Morgagni Pierantoni; Patologia clinica

    Forlì, Emilia-Romagna, 47100

  • Ospedale San Giuseppe; U.O. di Pneumologia

    Milan, Lombardy, 20123

  • Asst Santi Paolo E Carlo

    Milan, Lombardy, 20142

  • A.O.U. Policlinico di Modena

    Modena, Emilia-Romagna, 40124

  • Ospedale San Gerardo

    Monza, Lombardy, 20900

  • "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "

    Naples, Campania, 80131

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1

    Padova, Veneto, 35128

  • Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

    Palermo, Sicily, 90127

  • Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia

    Palermo, Sicily, 90127

  • Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia

    Pavia, Lombardy, 27100

  • Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio

    Rome, Lazio, 00133

  • Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

    Rome, Lazio, 00168

  • A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

    Sassari, Sardinia, 07100

  • A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

    Siena, Tuscany, 53100

  • University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center

    Treviso, Veneto, 31100

Other trials in Italy

Japan20 sites

  • Nagoya University Hospital

    Aichi, 466-8560

  • Chiba University Hospital

    Chiba, 260-8677

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • Fukuoka University Hospital

    Fukuoka, 814-0180

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047

  • National Hospital Organization Himeji Medical Center

    Hyōgo, 670-8520

  • Kameda Medical Center

    Kamogawa, 296-0041

  • Kanagawa Cardiovascular and Respiratory Center

    Kanagawa, 236-0051

  • Nippon Medical School Musashi Kosugi Hospital

    Kawasaki-Shi

  • Saiseikai Kumamoto Hospital

    Kumamoto, 861-4101

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

    Naka-gun, 319-1113

  • Kurashiki Central Hospital

    Okayama, 710-8602

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakaishi, 591-8555

  • Tosei General Hospital

    Seto-shi, 489-8642

  • Tenri Hospital

    Tenri-Shi, 632-8552

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology

    Tokyo, 113-0034

  • Center Hospital of the National Center for Global Health and Medicine

    Tokyo, 162-0052

Other trials in Japan

Turkey (Türkiye)14 sites

  • Istanbul Universitesi Onkoloji Enstitüsü Hastanesi

    ?stanbul, 34093

  • Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali

    Adana, 1330

  • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

    Ankara, 06620

  • Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

    Bursa, 16059

  • Gaziantep Universitesi Tip Fakultesi

    Gaziantep, 27310

  • Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi

    Istanbul, 34020

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Dokuz Eylul University Faculty of Medicine; Chest Diseases

    Izmir, 35340

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Marmara Universitesi Hastanesi Marmara University Hospital

    Maltepe, 34854

  • Eriyes universitesi T?p Fakultesi Hastanesi

    Melikgazi/Kayser, 38039

  • Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi

    Mersin, 33110

  • Akdeniz University Faculty of Medicine Department of Pulmonology

    Muratpasa/Antalya, 07059

  • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

    Sariyer, 34450

Other trials in Turkey (Türkiye)

France13 sites

  • Hopital Avicenne

    Bobigny, 93000

  • Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche

    Brest, 29200

  • Hopital Louis Pradel

    Bron, 69677

  • CHU Hopitaux de Bordeaux

    CHU Hopitaux de Bordeaux, 33000

  • CHU Dijon Bourgogne Hôpital François Mitterand

    Dijon, 21000

  • CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie

    La Tronche, 38700

  • Centre Hospitalier Regional Universitaire de Lille

    Lille

  • Servie de Pneumologie et centre de Transplantation Pulmonaire

    Marseille, 13354

  • CHU Nice - Hôpital Pasteur 2

    Nice, 06000

  • Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie

    Paris, 75018

  • Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche

    Reims, 51092

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033

  • CHU Tours - Hôpital Bretonneau

    Tours, 37044

Other trials in France

Israel12 sites

  • Barzilai Medical Center; Neurology Department

    Ashkelon, 7830604

  • Shamir medical center

    Be’er Ya‘aqov, 0070300

  • Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109600

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 9112000

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petach Tiqwa, 4941492

  • The Chaim Sheba Medical Center

    Ramat Gan, 5211401

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center; Department of Neurology

    Tel Aviv, 6423906

Other trials in Israel

Argentina10 sites

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

  • Fundacion Respirar (Centro Medico Dra. De Salvo)

    Ciudad Autonoma Buenos Aires, C1426ABP

  • Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

    Córdoba, X5003DCE

  • Hospital Universitario Austral

    Derqui-Pilar, B1629ODT

  • Centro Medico de Enfermedades Respiratorias (CEMER)

    Florida, Buenos Aires, B1602DQD

  • Centro de estudios respiratorios

    Mar del Plata, B7600CLK

  • Fundacion Scherbovsky

    Mendoza, M5500AYB

  • INSARES

    Mendoza, Mendoza City, M5500CCG

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, S2000DEJ

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, T4000IAR

Other trials in Argentina

China10 sites

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050

  • Peking Union Medical College Hospital; Pharmacy

    Beijing, 100730

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • The Third Xiangya Hospital Of Central South University

    Changsha, 410013

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Hebei Medical University - The Second Hospital

    Shijiazhuang, 050004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • Wuxi People's Hospital

    Wuxi, 214023

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Greece9 sites

  • Evangelismos Hospital; Endocrinology, Diabetes & Metabolism

    Athens, 10676

  • Attikon University General Hospital

    Chaïdári, 124 62

  • University General Hospital of Heraklion

    Heraklio, 711 10

  • University Hospital of Ioannina; Pulmonology Department

    Ioannina, 455 00

  • Athens Medical Center

    Marousi, 151 25

  • University of Thessaly Faculty of Medicine

    Mezourlo, 41110

  • University General Hospital of Patras

    Pátrai, 265 00

  • "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "

    Sotiria Athens, 115 27

  • General Hospital of Thessaloniki G. Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

South Korea9 sites

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

    Gyeonggi-do, 14662

  • Gacheon University Gil Medical Center

    Namdong-gu, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707

  • The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology

    Seoul, (0)7345

  • Seoul National University Hospital (SNUH) - Medical Oncology Center

    Seoul, 03080

  • Soonchunhyang University Hospital

    Seoul, 04401

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Taiwan7 sites

  • Buddhist Tzu Chi Dalin General Hospital; Rheumatology

    Chiayi City, 622

  • Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

    Kaoshiung City, 807

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70457

  • National Taiwan University Hospital

    Taipei, 10002

  • Far Eastern Memorial Hospital; Department of Clinical Pathology

    Taipei, 220

  • Veterans General Hospital - Taichung

    Xitun Dist., 40705

Other trials in Taiwan

Australia6 sites

  • Cairns Base Hospital; Cancer Care Centre

    Cairns, Queensland, 4870

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre; Medicine

    Melbourne, Victoria, 3186

  • Lung Research Queensland

    Nundah, Queensland, 4101

  • The Alfred Hospital

    Prahan, Victoria, 3181

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Germany6 sites

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125

  • Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik

    Heidelberg, 69126

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

    Marburg, 35037

  • Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken

    Münnerstadt, 97702

  • Krankenhaus Bethanien gGmbH

    Solingen, 42699

Other trials in Germany

Belgium5 sites

  • ULB Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc; Pharmacy

    Brussels, 1200

  • UZ Leuven

    Leuven, 3000

  • C. H. U. Sart-Tilman; Laboratory

    Liège, 4000

  • CHU UCL Namur / site Godinne

    Yvoir, B5530

Other trials in Belgium

Canada5 sites

  • Kelowna Respiratory and Allergy Clinic

    Kelowna, British Columbia, V1W 1V3

  • The Rhema Research Institute

    Owen Sound, Ontario, N4K 6M9

  • Synergy Respiratory Care

    Sherwood Park, Alberta, T8H ON2

  • C.I.C. Mauricie

    Trois-Rivières, Quebec, G8T 7A1

  • Dr. Syed Anees Medicine Profession Corporation

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Hungary5 sites

  • Semmelweis University

    Budapest, 1081

  • Debreceni Egyetem

    Debrecen, 4032

  • Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

    Szombathely, 9700

  • Szent Borbala Korhaz

    Tatabánya, 2800

  • Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

    Törökbálint, 2045

Other trials in Hungary

Mexico5 sites

  • Unidad de Investigacion CIMA SC

    Chihuahua City, 31200

  • Centro Respiratorio de México

    México, Mexico CITY (federal District), 14050

  • INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

    Mexico City, Mexico CITY (federal District), 14080

  • CICC Morelia

    Morelia

  • Unidad Médica para la Salud Integral UMSI

    San Nicolás de los Garza, Nuevo León, 66465

Other trials in Mexico

New Zealand5 sites

  • Auckland City Hospital

    Auckland, 1023

  • NZ Respiratory & Sleep Institute

    Auckland, 1051

  • University of Otago, Christchurch

    Christchurch, 8011

  • Waikato Hospital; Gastro Research

    Hamilton, 3240

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

Czechia4 sites

  • Fakultni nemocnice Brno

    Brno, 613 00

  • Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie

    Hradec Králové, 500 05

  • Thomayerova nemocnice; Lekarna - pavilon H

    Prague, 140 00

  • Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni

    Zlín, 760 01

Other trials in Czechia

Portugal4 sites

  • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

    Braga, 4710-243

  • Centro Hospitalar do Alto Ave; EPE

    Guimarães, 4835-044

  • Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente

    Lisbon, 1769-001

  • CHVNG/E_Unidade 1; Servico de Pneumologia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Norway3 sites

  • Helse Bergen HF Haukeland universitetssykehus; Hudavdelingen

    Bergen, 5021

  • Akershus universitetssykehus

    Lørenskog, 1478

  • Oslo University Hospital HF, Rikshospitalet

    Oslo, 0424

Other trials in Norway

Poland3 sites

  • Centrum Medycyny Oddechowej Mroz sp. j.

    Bia?ystok, 15-044

  • Nasz Lekarz Osrodek Badan Klinicznych

    Bydgoszcz, 85-312

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153

Other trials in Poland

Singapore3 sites

  • National University Hospital

    Singapore, 117599

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital; Oncology

    Singapore, 308433

Other trials in Singapore

Denmark2 sites

  • Gentofte Hospital

    Hellerup, 2900

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Hong Kong2 sites

  • Prince of Wales Hospital; Dept. of Medicine & Therapeutics

    Hong Kong

  • The University of Hong Kong; Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

Netherlands2 sites

  • Sint Antonius Ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3430 EM

  • Erasmus Medisch Centrum

    Rotterdam, 3000 CA

Other trials in Netherlands

South Africa2 sites

  • University of Cape Town Lung Institute; Lung Clinical Research

    Cape Town, 7700

  • Vergelegen Medi-Clinic

    Somerset West, 7130

Other trials in South Africa

About this study

Official title: 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).

Read the 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.

Being tested
PRM-151 (Zinpentraxin Alfa)
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRM-151 (Zinpentraxin Alfa)Drug

    Also called 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.

Study groups in NCT04594707
Study groupRoleWhat they receive
Zinpentraxin AlfaExperimentalCorhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.
Receives: Drug: PRM-151 (Zinpentraxin Alfa)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0.

    Measured: From baseline until 8 weeks after the final dose, an average of 6 months

  2. Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest

    IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion.

    Measured: From baseline until 8 weeks after the final dose, an average of 6 months

  3. Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs

    Measured: From baseline until 8 weeks after the final dose, an average of 6 months

Secondary outcomes (11)

  1. Annual Rate of Change in Forced Vital Capacity (FVC) (mL)

    Measured: From baseline until study completion (up to approximately 1.5 years)

  2. Annual Rate of Change in 6-Minute Walk Distance (6MWD)

    Measured: From baseline until study completion (up to approximately 1.5 years)

  3. Annual Rate of Change in FVC% Predicted

    Measured: From baseline until study completion (up to approximately 1.5 years)

  4. Change in Carbon Monoxide Diffusing Capacity (DLCO)

    Measured: At Baseline, Week 24 and Week 48

  5. Time to Disease Progression

    Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death

    Measured: From baseline until study completion (up to approximately 1.5 years)

  6. Survival

    Measured: Every 6 Months and at study completion (up to approximately 1.5 years)

  7. IPF-related Mortality

    Measured: Every 6 Months and at study completion (up to approximately 1.5 years)

  8. Respiratory-related Mortality

    Measured: Every 6 Months and at study completion (up to approximately 1.5 years)

  9. Plasma Concentrations of PRM-151 at Specified Timepoints

    Due to early termination of the study, only participants enrolled in Cohort A receiving at least one IV dose of zinpentraxin alfa had their plasma concentrations analyzed.

    Measured: Days 1 and 5, Weeks 4, and 12

  10. Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline

    Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.

    Measured: Baseline (Day 1)

  11. Percentage of Participants With ADAs During the Study

    Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.

    Measured: Weeks 4, 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start30 Aug 2021
  3. Primary completion10 Feb 2023
  4. Study completion10 Feb 2023

Why it stopped: The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04594707
Sponsor's protocol ID
WA42294
Other IDs
2020-001429-30
Acronym
STARSCAPE-OLE
Status last verified
May 2024
First submitted
15 Oct 2020
Last updated
16 May 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Mantovani A, Garlanda C. Humoral Innate Immunity and Acute-Phase Proteins. N Engl J Med. 2023 Feb 2;388(5):439-452. doi: 10.1056/NEJMra2206346. No abstract available.

    PubMed 36724330

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRM-151 (Zinpentraxin Alfa) in people with Idiopathic Pulmonary Fibrosis, run by Hoffmann-La Roche at 248 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 248 sites in United States, Spain, Italy, Japan, Turkey (Türkiye) and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) (time frame: From baseline until 8 weeks after the final dose, an average of 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04594707, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in