AzTrials
AzTrials

Idiopathic Pulmonary FibrosisPhase 3STARSCAPENCT04552899

A Study to Evaluate the Efficacy and Safety 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 360 sites in 35 countries.

Terminated

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

Official record
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Trial summary

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

Who is it for?
Ages 40 to 85 years
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?
Yes, some participants may receive a placebo
How many people
665 participants
Where
360 sitesin 35 countries
Study dates
19 Mar 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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

360 sites in 35 countries.

360 sites in 35 countries

United States72 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

    Aurora, Colorado, 80045

  • Piedmont Healthcare Pulmonary and Critical Care Research

    Austell, Georgia, 30106

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham & Women'S Hospital

    Boston, Massachusetts, 02115

  • Meris Clinical Research

    Brandon, Florida, 33511-5719

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

    Celebration, Florida, 34747-1818

  • Medical University of South Carolina Hospital

    Charleston, South Carolina, 29425

  • American Health Research Inc.

    Charlotte, North Carolina, 28277

  • The Lung Research Center

    Chesterfield, Missouri, 63017-3625

  • University of Cincinnati Cancer Institute

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • SleepMed of South Carolina

    Columbia, South Carolina, 29201-2953

  • Horizon Clinical Research Group

    Cypress, Texas, 77429

  • Cardiopulmonary Research Science and Technology Institute

    Dallas, Texas, 75230

  • University of Texas Southwestern Medical Center; Heart and Lung Clinic

    Dallas, Texas, 75390-8575

  • Advanced Pulmonary & Sleep Research Institute of Florida

    Daytona Beach, Florida, 32117

  • National Jewish Health Medical Center

    Denver, Colorado, 80045-2541

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital/IHVI; Cardiology

    Falls Church, Virginia, 22042

  • University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine

    Gainesville, Florida, 32608-3928

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608

  • University of Texas Medical Branch; Cardiology Department

    Galveston, Texas, 77555

  • Pulmonix Research

    Greensboro, North Carolina, 27403-1127

  • Indiana Univ School of Med

    Indianapolis, Indiana, 46202

  • 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

  • DCOL Center for Clinical Research

    Longview, Texas, 75605-2410

  • University of Louisville Health Sciences Center

    Louisville, Kentucky, 40202

  • Advanced Pulmonary Research Institute

    Loxahatchee Groves, Florida, 33470-9216

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Metroplex Pulmonology & Sleep Center

    McKinney, Texas, 75069

  • San Marcus Research Clinic Inc.

    Miami, Florida, 33014

  • 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

  • Renstar Medical Research

    Ocala, Florida, 34470

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-0600

  • UC Irvine Medical Center

    Orange, California, 92868

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • Stanford Hospital and Clinics

    Palo Alto, California, 94304

  • Jefferson University Physicians (JUP) - Jefferson Pulmonary

    Philadelphia, Pennsylvania, 19107

  • Temple University Medical Center

    Philadelphia, Pennsylvania, 19140-4105

  • Banner University Medical Center Phoenix; Main Pharmacy

    Phoenix, Arizona, 85006

  • Lovelace Scientific Resources, Inc.

    Phoenix, Arizona, 85016

  • 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

  • Covenant Medical Center - Cooper

    Saginaw, Michigan, 48602-5383

  • University Of Utah Hosp & Clin; Investigational Pharmacy

    Salt Lake City, Utah, 84132

  • Audie L. Murphy VA Hospital, STVHCS

    San Antonio, Texas, 78229

  • Inst. of Healthcare Assessment, Inc.

    San Diego, California, 92120

  • UCSF Medical Center

    San Francisco, California, 94143-0748

  • Paloma Medical Group

    San Juan Capistrano, California, 92675

  • William Sansum Diabetes Center

    Santa Barbara, California, 93105

  • Sarasota Memorial Health Care System; Cancer Research Program

    Sarasota, Florida, 34239

  • Spartanburg Medical Center

    Spartanburg, South Carolina, 29303

  • Washington University

    St Louis, Missouri, 63128

  • Pulmonary & Allergy Associates

    Summit, New Jersey, 07901-4055

  • University of South Florida

    Tampa, Florida, 33612

  • Mercy St. Vincent Medical Center

    Toledo, Ohio, 43608

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Integral ? Clinical Trial Solutions

    Weston, Florida, 33327

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Clinical Site Partners Orlando

    Winter Park, Florida, 32789

Other trials in United States

China31 sites

  • CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Beijing Friendship Hospital Affiliated of Capital University of Medical Science

    Beijing, 100050

  • Peking University Third Hospital

    Beijing, 100191

  • Peking Union Medical College Hospital; Pharmacy

    Beijing, 100730

  • Xiangya Hospital Central South University

    Changsha, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • The Third Xiangya Hospital Of Central South University

    Changsha, 410013

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Southern Medical University Nanfang Hospital

    Guangdong Province Guangzhou City, 510515

  • The First Affilicated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • 1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy

    Hangzhou, 310003

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, 010011

  • Qilu Hospital of Shandong University

    Jinan, 250012

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008

  • Ningbo First Hospital

    Ningbo, 315010

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200025

  • Huadong Hospital Affiliated to Fudan University

    Shanghai, 200040

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • China Medical University (CMU) First Affiliated Hospital

    Shenyang, 110001

  • 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

  • Tangdu Hospital, The Fourth Military Medical University; Neurology Department

    Xi'an, 710038

  • Qinghai Provincial People?s Hospital

    Xining, 810007

  • Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital

    Zhengzhou, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052

Other trials in China

Spain30 sites

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

    Barcelona, 08025

  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    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

    Madrid, 28006

  • Hospital Universitario La Paz

    Madrid, 280146

  • Clínica Universidad de Navarra ? Madrid

    Madrid, 28027

  • Hospital Ramón y Cajal;Servicio de Neumología

    Madrid, 28034

  • Hosp. Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28220

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Universidad de Navarra - Clinica Universitaria de Navarra (CUN)

    Pamplona, Navarre, 31008

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Canarias

    S. Cristobal de La Laguna, Tenerife, 38320

  • Parc Taulí Sabadell Hospital Universitari

    Sabadell, Barcelona, 8208

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Arnau de Vilanova (Valencia)

    Valencia, 46015

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Txagorritxu

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

Italy28 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

  • "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "

    Garbagnate Milanese, Lombardy

  • 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

  • AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

    Naples, Campania, 80131

  • Azienda Ospedaliera Dei Colli

    Naples, Campania, 80131

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

  • Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

    Naples, Campania, 80131

  • A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

    Orbassano (TO), Piedmont, 10043

  • Ospedale di Ostuni - Pneumologia

    Ostuni, Apulia, 72017

  • Azienda Ospedale Università Di Padova; Clinica Pneumologica

    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

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Torrette Di Ancona, The Marches, 60126

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

    Treviso, Veneto, 31100

  • Azienda Sanitaria Universitaria Integrata di Trieste

    Trieste, Friuli Venezia Giulia, 34125

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette

    Turin, Piedmont, 10026

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

France16 sites

  • Hopital Avicenne

    Bobigny, 93000

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

    Brest, 29200

  • Hopital Louis Pradel

    Bron, 69677

  • Hospital d Instructions des Armees Percy

    Clamart, 92141

  • 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 de Montpellier Hopital Arnaud de Villeneuve; de Génétique

    Montpellier, 34295

  • CHU Nice - Hôpital Pasteur 2

    Nice, 06000

  • Hopital Bichat Claude Bernard; CIC

    Paris, 75877

  • European Hospital Georges Pompidou (HEGP)

    Paris, 75908

  • Hopital Haut Leveque

    Pessac, 33600

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

    Reims, 51092

  • CHU de Rennes - Hopital de Pontchaillo

    Rennes, 35033

  • CHU Tours - Hôpital Bretonneau; Pharmacie

    Tours, 37044

Other trials in France

Germany14 sites

  • Zentralklinik Bad Berka GmbH; Pneumologie

    Bad Berka, 99437

  • Evang. Lungenklinik Berlin Klinik für Pneumologie

    Berlin, 13125

  • Universitatsklinikum Essen; Innere Klinik

    Essen, 45122

  • IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

    Frankfurt am Main, 60596

  • Universitatsklinikum Gießen und Marburg GmbH

    Giessen, 35385

  • Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie

    Hanover, 30625

  • Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik

    Heidelberg, 69126

  • Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

    Homburg/Saar, 66424

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Universitatsklinikum Leipzig; Apotheke

    Leipzig, 04103

  • IKF Pneumologie Mainz Helix Medical Excellence Center Mainz

    Mainz, 55128

  • 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

Israel14 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

  • Bnai Zion Medical Center; Internal Medicine

    Haifa, 3339419

  • Carmel Medical Center; Obstetrics and Gynecology

    Haifa, 34362

  • Edith Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center; Nrphrology Dept.

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 9112001

  • 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 Pulmonary

    Tel Aviv, 64239

Other trials in Israel

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 - Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep

  • Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari

    Istanbul, 34020

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Dokuz Eylul University Faculty of Medicine; Chest Diseases

    Izmir, 35340

  • Erciyes Üniversitesi T?p Fakültesi

    Kayseri, 38039

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Marmara Universitesi Hastanesi Marmara University Hospital

    Maltepe, 34854

  • Mersin Üniversitesi Tip Fakültesi

    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)

South Korea11 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, 420-767

  • 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

  • The Catholic University of Korea Seoul St. Mary?s Hospital

    Seoul, 6591

Other trials in South Korea

Canada10 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 1Z1

  • Kelowna Respiratory and Allergy Clinic

    Kelowna, British Columbia, V1W 1V3

  • Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital

    Montreal, Quebec, H2X 1R9

  • McGill University, Montreal Chest Institute; Viral and other Infectious

    Montreal, Quebec, H2X2P4

  • The Rhema Research Institute

    Owen Sound, Ontario, N4K 6M9

  • Synergy Respiratory Care

    Sherwood Park, Alberta, T8H ON2

  • Eastern Health - General Hospital

    St. John's, Newfoundland and Labrador, A1B 3V6

  • C.I.C. Mauricie

    Trois-Rivières, Quebec, G8T 7A1

  • Vancouver General Hospital; Gordon and Leslie Diamond Health Care

    Vancouver, British Columbia, V5Z 1L7

  • Dr. Syed Anees Medicine Profession Corporation

    Windsor, Ontario, N8X 1T3

Other trials in Canada

Australia9 sites

  • The Queen Elizabeth Hospital

    Adelaide, South Australia, 5011

  • Cairns Base Hospital; Cancer Care Centre

    Cairns, Queensland, 4870

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Austin Hospital; Cancer Clinical Trials Centre

    Melbourne, Victoria, 3084

  • Monash Medical Centre; Medicine

    Melbourne, Victoria, 3186

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Lung Research Queensland

    Nundah, Queensland, 4101

  • The Alfred Hospital

    Prahan, Victoria, 3181

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Greece9 sites

  • Evangelismos Hospital; Department of Critical Care and Pulmonary Services

    Athens, 106 76

  • Attikon University General Hospital

    Chaïdári, 124 62

  • University General Hospital of Heraklion

    Heraklio, 711 10

  • University Hospital of Ioannina; Pulmonology Department

    Ioannina, 455 00

  • Hospital is University General Hospital of Larissa

    Larissa, 41110

  • Athens Medical Center

    Marousi, 151 25

  • 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

Argentina8 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

  • 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

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, T4000IAR

Other trials in Argentina

Portugal8 sites

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

    Braga, 4710-243

  • Centro Hospitalar Algarve

    Faro, 8000-386

  • Hospital Senhora da Oliveira ? Guimarães, E.P.E

    Guimarães, 4835-044

  • Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente

    Lisbon, 1769-001

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001

  • Hospital de Sao Joao; Centro de Investigacao

    Porto, 4200-319

  • Hospital de Santa Luzia

    Porto, 4904-858

  • CHVNG/E_Unidade 1; Servico de Pneumologia

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

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

Czechia6 sites

  • Fakultní Nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie

    Pilsen, 305 99

  • Thomayerova nemocnice; Lekarna - pavilon H

    Prague, 140 00

  • Nemocnice Na Bulovce

    Prague, 180 01

  • Krajská nemocnice T. Bati, a. s.

    Zlín, 762 75

Other trials in Czechia

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

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

United Kingdom4 sites

  • Edinburgh Royal Infirmary; Respiratory Department

    Edinburgh, EH16 4SA

  • Royal Brompton Hospital; Respiratory Department

    London, SW3 6NP

  • Manchester University NHS Foundation Trust - Wythenshawe Hospital

    Manchester, M23 9LT

  • North Manchester General Hospital

    Manchester, M8 5RB

Other trials in United Kingdom

Denmark3 sites

  • Aarhus Universitetshospital Skejby

    Aarthus N, 8200

  • Gentofte Hospital

    Hellerup, 2900

  • Odense Universitetshospital

    Odense C, 5000

Other trials in Denmark

Netherlands3 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Sint Antonius Ziekenhuis, locatie Nieuwegein

    Nieuwegein, 3430 EM

  • Erasmus Medisch Centrum

    Rotterdam, 3000 CA

Other trials in Netherlands

Norway3 sites

  • Helse Bergen HF Haukeland universitetssykehus

    Bergen, 5053

  • 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

  • Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

    Lodz, 90-153

Other trials in Poland

Ukraine3 sites

  • Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council

    Dnipro, Katerynoslav Governorate, 49069

  • National Academy of Medical Science of Ukraine (NAMS); NRCRM

    Kyiv, KIEV Governorate, 03115

  • Yanovskyy Inst of Phth. & Pulm; Clinical-functional

    Kyiv, 03680

Other trials in Ukraine

Austria2 sites

  • Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung

    Klagenfurt, 9020

  • Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

    Salzburg, 5020

Other trials in Austria

Brazil2 sites

  • Hospital das Clinicas - UFMG

    Belo Horizonte, Minas Gerais, 31270-901

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

Other trials in Brazil

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

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital; Oncology

    Singapore, 308433

Other trials in Singapore

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

Switzerland2 sites

  • Inselspital Bern Universitätsklinik für Pneumologie

    Bern, 3010

  • Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)

    Neuchâtel, 2000

Other trials in Switzerland

Finland1 site

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Sweden1 site

  • Skånes universitetssjukhus Malmö

    Malmö, 214 28

Other trials in Sweden

About this study

Official title: 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).

Being tested
PRM-151 (Zinpentraxin Alfa), Placebo
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

    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.

  • PlaceboDrug

    Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

Study groups in NCT04552899
Study groupRoleWhat they receive
Zinpentraxin AlfaExperimentalParticipants will receive intravenous (IV) infusions of Zinpentraxin Alfa over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.
Receives: Drug: PRM-151 (Zinpentraxin Alfa)
PlaceboPlacebo comparatorParticipants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Receives: Drug: Placebo

What is being measured

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

  1. Absolute Change in Forced Vital Capacity (FVC [mL])

    Measured: From Baseline up to Week 52

Secondary outcomes (15)

  1. Absolute Change in 6-minute Walk Distance (6MWD)

    Measured: From Baseline up to Week 52

  2. Absolute Change in FVC% Predicted

    Measured: From Baseline up to Week 52

  3. Time to Disease Progression

    Measured: From Baseline up to 1 year

  4. Time to First Respiratory-related Hospitalizations

    Measured: From Baseline up to 1 year

  5. Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)

    The UCSD-SOBQ is a 24-item questionnaire used to assess dyspnea severity during specific activities (21 items) and limitations caused by dyspnea in daily life (4 items). Items are assessed using a 6-point scale. Total scores, once summed, can range from 0-120 with a higher score reflecting greater dyspnea severity.

    Measured: At Baseline, Week 12, Week 24, Week 36 and Week 52

  6. Change in St. George Respiratory Questionnaire (SGRQ) Total Score

    The SGRQ is a 50-item respiratory-specific quality-of-life questionnaire. The questions assess the impact of disease on activity, functionality and symptoms. Each scale is scored from 0-100. A total score represents the weighted average of these three subscores. A lower score indicates best health while a higher score indicates worst health.

    Measured: At Baseline, Week 12, Week 24, Week 36 and Week 52

  7. Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)

    Measured: From Baseline up to 1 year

  8. Change in Carbon Monoxide Diffusing Capacity (DLCO)

    Measured: At Baseline, Week 12, Week 24, Week 36 and Week 52

  9. Survival

    Survival is measured by all-cause mortality

    Measured: From Baseline up to 1 year

  10. Percentage of Participants With Adverse Events (AEs)

    Measured: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)

  11. Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest

    Measured: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)

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

    Measured: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)

  13. Plasma Concentrations of PRM-151

    Measured: Days 1, 5 and Weeks 4, 12, and 24

  14. Prevalence of Anti-drug Antibodies (ADAs) at Baseline

    Measured: At Baseline

  15. Percentage of Participants With ADAs During the Study

    Measured: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56

Timeline

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

  1. First posted17 Sep 2020
  2. Study start19 Mar 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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
665 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552899
Sponsor's protocol ID
WA42293
Other IDs
2020-000791-38
Acronym
STARSCAPE
Status last verified
Mar 2024
First submitted
14 Sep 2020
Last updated
18 Apr 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

  • Cong M, Carvalho Gontijo Weber R, Sakane S, Zhang V, Jiang C, Taura K, Kodama Y, DeMinicis S, Ganguly S, Brafman D, Chien S, Kramer M, Lupher M, Brenner DA, Xu J, Kisseleva T. Serum amyloid P (PTX2) attenuates hepatic fibrosis in mice by inhibiting the activation of fibrocytes and HSCs. Hepatol Commun. 2024 Oct 17;8(11):e0557. doi: 10.1097/HC9.0000000000000557. eCollection 2024 Nov 1.

    PubMed 39761005

  • Richeldi L, Schiffman C, Behr J, Inoue Y, Corte TJ, Cottin V, Jenkins RG, Nathan SD, Raghu G, Walsh SLF, Jayia PK, Kamath N, Martinez FJ. Zinpentraxin Alfa for Idiopathic Pulmonary Fibrosis: The Randomized Phase III STARSCAPE Trial. Am J Respir Crit Care Med. 2024 May 1;209(9):1132-1140. doi: 10.1164/rccm.202401-0116OC.

    PubMed 38354066

  • 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 360 sites in 35 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 14 inclusion and 19 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 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 360 sites in United States, China, Spain, Italy, Japan and 30 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. Some participants in this study may receive a placebo. 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 18 Apr 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?

Absolute Change in Forced Vital Capacity (FVC [mL]) (time frame: From Baseline up to Week 52). 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 NCT04552899, which also lists 3 linked publications.

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 18 Apr 2024.

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