Study 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.
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
STARSCAPE
A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis
2 other identifiers
interventional
665
34 countries
351
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2021
351 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2020
CompletedFirst Posted
Study publicly available on registry
September 17, 2020
CompletedStudy Start
First participant enrolled
March 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2023
CompletedResults Posted
Study results publicly available
April 18, 2024
CompletedApril 18, 2024
March 1, 2024
1.9 years
September 14, 2020
February 2, 2024
March 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change in Forced Vital Capacity (FVC [mL])
From Baseline up to Week 52
Secondary Outcomes (15)
Absolute Change in 6-minute Walk Distance (6MWD)
From Baseline up to Week 52
Absolute Change in FVC% Predicted
From Baseline up to Week 52
Time to Disease Progression
From Baseline up to 1 year
Time to First Respiratory-related Hospitalizations
From Baseline up to 1 year
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
At Baseline, Week 12, Week 24, Week 36 and Week 52
- +10 more secondary outcomes
Study Arms (2)
Zinpentraxin Alfa
EXPERIMENTALParticipants 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.
Placebo
PLACEBO COMPARATORParticipants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Interventions
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Eligibility Criteria
You may qualify if:
- Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline
- High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)
- Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (\>/= )83% during the 6 minute walk test (6MWT) during screening
- FVC \>/= 45% predicted during screening as determined by the over-reader
- Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (\>) 0.70 during screening determined by the over-reader
- Diffusing capacity for carbon monoxide (DLCO) \>/= 30% and less than or equal to (\</=) 90% of predicted at screening as determined by the over-reader
- If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening
- If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment \>/= 4 weeks prior to screening and during screening
- Anticipated life expectancy of at least 12 months at baseline
- Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.
- For women of childbearing potential (excluding participant enrolling in Japan): agreement to remain abstinent or use contraception
- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
- Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment
- For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry
You may not qualify if:
- Evidence of other known causes of Interstitial Lung Disease (ILD)
- FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value
- Emphysema present on greater than or equal to (\>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
- Receiving nintedanib in combination with pirfenidone
- Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening
- Receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks prior to or during screening
- Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit
- Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test \[interferon gamma release assay\])
- Resting oxygen saturation of \< 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (\>/= 5000 feet \[1524 meters\] above sea level) during screening
- Class IV New York Heart Association chronic heart failure
- Historical evidence of left ventricular ejection fraction \< 35%
- Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study
- Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial
- History of smoking, alcohol or substance abuse disorder, or a malignancy
- Previous treatment with PRM-151
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (360)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Banner University Medical Center Phoenix; Main Pharmacy
Phoenix, Arizona, 85006, United States
Lovelace Scientific Resources, Inc.
Phoenix, Arizona, 85016, United States
UC Irvine Medical Center
Orange, California, 92868, United States
Stanford Hospital and Clinics
Palo Alto, California, 94304, United States
University of California Davis
Sacramento, California, 95817, United States
Inst. of Healthcare Assessment, Inc.
San Diego, California, 92120, United States
UCSF Medical Center
San Francisco, California, 94143-0748, United States
Paloma Medical Group
San Juan Capistrano, California, 92675, United States
William Sansum Diabetes Center
Santa Barbara, California, 93105, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora, Colorado, 80045, United States
National Jewish Health Medical Center
Denver, Colorado, 80045-2541, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Meris Clinical Research
Brandon, Florida, 33511-5719, United States
Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration
Celebration, Florida, 34747-1818, United States
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, 32117, United States
University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine
Gainesville, Florida, 32608-3928, United States
Malcom Randall VA Medical Center
Gainesville, Florida, 32608, United States
University of Florida Health Pulmonology - Jacksonville
Jacksonville, Florida, 32209, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, 33470-9216, United States
San Marcus Research Clinic Inc.
Miami, Florida, 33014, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803, United States
Sarasota Memorial Health Care System; Cancer Research Program
Sarasota, Florida, 34239, United States
University of South Florida
Tampa, Florida, 33612, United States
Integral ? Clinical Trial Solutions
Weston, Florida, 33327, United States
Clinical Site Partners Orlando
Winter Park, Florida, 32789, United States
Emory University
Atlanta, Georgia, 30322, United States
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, 30106, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Indiana Univ School of Med
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics; Investigational Drug Services
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville Health Sciences Center
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women'S Hospital
Boston, Massachusetts, 02115, United States
Covenant Medical Center - Cooper
Saginaw, Michigan, 48602-5383, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 29425-8911, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
The Lung Research Center
Chesterfield, Missouri, 63017-3625, United States
Washington University
St Louis, Missouri, 63128, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-0600, United States
Pulmonary & Allergy Associates
Summit, New Jersey, 07901-4055, United States
Lenox Hill Hospital
New York, New York, 10075, United States
American Health Research Inc.
Charlotte, North Carolina, 28277, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Pulmonix Research
Greensboro, North Carolina, 27403-1127, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
University of Cincinnati Cancer Institute
Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Jefferson University Physicians (JUP) - Jefferson Pulmonary
Philadelphia, Pennsylvania, 19107, United States
Temple University Medical Center
Philadelphia, Pennsylvania, 19140-4105, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, 29425, United States
SleepMed of South Carolina
Columbia, South Carolina, 29201-2953, United States
Lowcountry Lung and Critical Care
North Charleston, South Carolina, 29406, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Horizon Clinical Research Group
Cypress, Texas, 77429, United States
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, 75230, United States
University of Texas Southwestern Medical Center; Heart and Lung Clinic
Dallas, Texas, 75390-8575, United States
University of Texas Medical Branch; Cardiology Department
Galveston, Texas, 77555, United States
DCOL Center for Clinical Research
Longview, Texas, 75605-2410, United States
Metroplex Pulmonology & Sleep Center
McKinney, Texas, 75069, United States
Audie L. Murphy VA Hospital, STVHCS
San Antonio, Texas, 78229, United States
University Of Utah Hosp & Clin; Investigational Pharmacy
Salt Lake City, Utah, 84132, United States
Inova Fairfax Hospital/IHVI; Cardiology
Falls Church, Virginia, 22042, United States
Virginia Commonwealth University
Richmond, Virginia, 23219-1901, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53792, United States
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Fundacion Respirar (Centro Medico Dra. De Salvo)
Ciudad Autonoma Buenos Aires, C1426ABP, Argentina
Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility
Córdoba, X5003DCE, Argentina
Centro Medico de Enfermedades Respiratorias (CEMER)
Florida, Buenos Aires, B1602DQD, Argentina
Centro de estudios respiratorios
Mar del Plata, B7600CLK, Argentina
Fundacion Scherbovsky
Mendoza, M5500AYB, Argentina
INSARES
Mendoza, Mendoza City, M5500CCG, Argentina
Investigaciones en Patologias Respiratorias
San Miguel de Tucumán, T4000IAR, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Cairns Base Hospital; Cancer Care Centre
Cairns, Queensland, 4870, Australia
Lung Research Queensland
Nundah, Queensland, 4101, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011, Australia
Austin Hospital; Cancer Clinical Trials Centre
Melbourne, Victoria, 3084, Australia
Monash Medical Centre; Medicine
Melbourne, Victoria, 3186, Australia
The Alfred Hospital
Prahan, Victoria, 3181, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
Klagenfurt, 9020, Austria
Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie
Salzburg, 5020, Austria
ULB Hôpital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires Saint-Luc; Pharmacy
Brussels, 1200, Belgium
UZ Leuven
Leuven, 3000, Belgium
C. H. U. Sart-Tilman; Laboratory
Liège, 4000, Belgium
CHU UCL Namur / site Godinne
Yvoir, B5530, Belgium
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, 31270-901, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
University of Alberta Hospital
Edmonton, Alberta, T6G 1Z1, Canada
Synergy Respiratory Care
Sherwood Park, Alberta, T8H ON2, Canada
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, V1W 1V3, Canada
Vancouver General Hospital; Gordon and Leslie Diamond Health Care
Vancouver, British Columbia, V5Z 1L7, Canada
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
The Rhema Research Institute
Owen Sound, Ontario, N4K 6M9, Canada
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 1T3, Canada
Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital
Montreal, Quebec, H2X 1R9, Canada
McGill University, Montreal Chest Institute; Viral and other Infectious
Montreal, Quebec, H2X2P4, Canada
C.I.C. Mauricie
Trois-Rivières, Quebec, G8T 7A1, Canada
CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine
Beijing, 100020, China
China-Japan Friendship Hospital
Beijing, 100029, China
Beijing Friendship Hospital Affiliated of Capital University of Medical Science
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100191, China
Peking Union Medical College Hospital; Pharmacy
Beijing, 100730, China
Xiangya Hospital Central South University
Changsha, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
The Third Xiangya Hospital Of Central South University
Changsha, 410013, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Southern Medical University Nanfang Hospital
Guangdong Province Guangzhou City, 510515, China
The First Affilicated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy
Hangzhou, 310003, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, 010011, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The 1st Affiliated Hospital of Nanchang Unversity
Nanchang, 330006, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
Ningbo First Hospital
Ningbo, 315010, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200025, China
Huadong Hospital Affiliated to Fudan University
Shanghai, 200040, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
China Medical University (CMU) First Affiliated Hospital
Shenyang, 110001, China
Shengjing Hospital of China Medical University
Shenyang, 110004, China
Hebei Medical University - The Second Hospital
Shijiazhuang, 050004, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030, China
Wuxi People's Hospital
Wuxi, 214023, China
Tangdu Hospital, The Fourth Military Medical University; Neurology Department
Xi'an, 710038, China
Qinghai Provincial People?s Hospital
Xining, 810007, China
Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital
Zhengzhou, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Fakultní Nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie
Pilsen, 305 99, Czechia
Thomayerova nemocnice; Lekarna - pavilon H
Prague, 140 00, Czechia
Nemocnice Na Bulovce
Prague, 180 01, Czechia
Krajská nemocnice T. Bati, a. s.
Zlín, 762 75, Czechia
Aarhus Universitetshospital Skejby
Aarthus N, 8200, Denmark
Gentofte Hospital
Hellerup, 2900, Denmark
Odense Universitetshospital
Odense C, 5000, Denmark
Turku University Hospital
Turku, 20521, Finland
Hopital Avicenne
Bobigny, 93000, France
Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche
Brest, 29200, France
Hopital Louis Pradel
Bron, 69677, France
Hospital d Instructions des Armees Percy
Clamart, 92141, France
CHU Dijon Bourgogne Hôpital François Mitterand
Dijon, 21000, France
CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie
La Tronche, 38700, France
Centre Hospitalier Regional Universitaire de Lille
Lille, France
Servie de Pneumologie et centre de Transplantation Pulmonaire
Marseille, 13354, France
CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique
Montpellier, 34295, France
CHU Nice - Hôpital Pasteur 2
Nice, 06000, France
Hopital Bichat Claude Bernard; CIC
Paris, 75877, France
European Hospital Georges Pompidou (HEGP)
Paris, 75908, France
Hopital Haut Leveque
Pessac, 33600, France
Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche
Reims, 51092, France
CHU de Rennes - Hopital de Pontchaillo
Rennes, 35033, France
CHU Tours - Hôpital Bretonneau; Pharmacie
Tours, 37044, France
Zentralklinik Bad Berka GmbH; Pneumologie
Bad Berka, 99437, Germany
Evang. Lungenklinik Berlin Klinik für Pneumologie
Berlin, 13125, Germany
Universitatsklinikum Essen; Innere Klinik
Essen, 45122, Germany
IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie
Frankfurt am Main, 60596, Germany
Universitatsklinikum Gießen und Marburg GmbH
Giessen, 35385, Germany
Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie
Hanover, 30625, Germany
Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik
Heidelberg, 69126, Germany
Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
Homburg/Saar, 66424, Germany
Lungenfachklinik Immenhausen
Immenhausen, 34376, Germany
Universitatsklinikum Leipzig; Apotheke
Leipzig, 04103, Germany
IKF Pneumologie Mainz Helix Medical Excellence Center Mainz
Mainz, 55128, Germany
Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup
Marburg, 35037, Germany
Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702, Germany
Krankenhaus Bethanien gGmbH
Solingen, 42699, Germany
Evangelismos Hospital; Department of Critical Care and Pulmonary Services
Athens, 106 76, Greece
Attikon University General Hospital
Chaïdári, 124 62, Greece
University General Hospital of Heraklion
Heraklio, 711 10, Greece
University Hospital of Ioannina; Pulmonology Department
Ioannina, 455 00, Greece
Hospital is University General Hospital of Larissa
Larissa, 41110, Greece
Athens Medical Center
Marousi, 151 25, Greece
University General Hospital of Patras
Pátrai, 265 00, Greece
"General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "
Sotiria Athens, 115 27, Greece
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki, 57010, Greece
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
Hong Kong, Hong Kong
The University of Hong Kong; Queen Mary Hospital
Hong Kong, Hong Kong
Semmelweis University
Budapest, 1081, Hungary
Debreceni Egyetem
Debrecen, 4032, Hungary
Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET
Szombathely, 9700, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum
Törökbálint, 2045, Hungary
Barzilai Medical Center; Neurology Department
Ashkelon, 7830604, Israel
Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute
Beersheba, 8410101, Israel
Shamir medical center
Be’er Ya‘aqov, 0070300, Israel
Rambam Health Care Campus
Haifa, 3109600, Israel
Bnai Zion Medical Center; Internal Medicine
Haifa, 3339419, Israel
Carmel Medical Center; Obstetrics and Gynecology
Haifa, 34362, Israel
Edith Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center; Nrphrology Dept.
Jerusalem, 9103102, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Rabin Medical Center
Petach Tiqwa, 4941492, Israel
The Chaim Sheba Medical Center
Ramat Gan, 5211401, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Tel-Aviv Sourasky Medical Center; Department of Pulmonary
Tel Aviv, 64239, Israel
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Abruzzo, 24060, Italy
Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia
Foggia, Apulia, 71122, Italy
Ospedale di Ostuni - Pneumologia
Ostuni, Apulia, 72017, Italy
AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico
Napoli, Campania, 80131, Italy
Azienda Ospedaliera Dei Colli
Napoli, Campania, 80131, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, Campania, 80131, Italy
Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche
Napoli, Campania, 80131, Italy
Ospedale Morgagni Pierantoni; Patologia clinica
Forlì, Emilia-Romagna, 47100, Italy
A.O.U. Policlinico di Modena
Modena, Emilia-Romagna, 40124, Italy
Azienda Sanitaria Universitaria Integrata di Trieste
Trieste, Friuli Venezia Giulia, 34125, Italy
Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio
Rome, Lazio, 00133, Italy
Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia
Rome, Lazio, 00168, Italy
"Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "
Garbagnate Milanese, Lombardy, Italy
Ospedale San Giuseppe; U.O. di Pneumologia
Milan, Lombardy, 20123, Italy
Asst Santi Paolo E Carlo
Milan, Lombardy, 20142, Italy
Ospedale San Gerardo
Monza, Lombardy, 20900, Italy
Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia
Pavia, Lombardy, 27100, Italy
A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone
Orbassano (TO), Piedmont, 10043, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette
Turin, Piedmont, 10026, Italy
A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale
Sassari, Sardinia, 07100, Italy
Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele
Catania, Sicily, 95123, Italy
Az. Osp. Univ. P. Giaccone; UOC di Pneumologia
Palermo, Sicily, 90127, Italy
Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia
Palermo, Sicily, 90127, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona, The Marches, 60126, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Florence, Tuscany, 50134, Italy
A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche
Siena, Tuscany, 53100, Italy
Azienda Ospedale Università Di Padova; Clinica Pneumologica
Padua, Veneto, 35128, Italy
University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center
Treviso, Veneto, 31100, Italy
Nagoya University Hospital
Aichi, 466-8560, Japan
Chiba University Hospital
Chiba, 260-8677, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, 810-8563, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kobe City Medical Center General Hospital
Hyōgo, 650-0047, Japan
National Hospital Organization Himeji Medical Center
Hyōgo, 670-8520, Japan
Kameda Medical Center
Kamogawa, 296-0041, Japan
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, 236-0051, Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasaki-Shi, Japan
Saiseikai Kumamoto Hospital
Kumamoto, 861-4101, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research
Naka-gun, 319-1113, Japan
Kurashiki Central Hospital
Okayama, 710-8602, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakaishi, 591-8555, Japan
Tosei General Hospital
Seto-shi, 489-8642, Japan
Tenri Hospital
Tenri-Shi, 632-8552, Japan
Jichi Medical University Hospital
Tochigi, 329-0498, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology
Tokyo, 113-0034, Japan
Center Hospital of the National Center for Global Health and Medicine
Tokyo, 162-0052, Japan
INER- Instituto Nacional de Enfermedades Respiratorias"Ismae
Mexico City, Mexico CITY (federal District), 14080, Mexico
Centro Respiratorio de México
México, Mexico CITY (federal District), 14050, Mexico
Unidad Médica para la Salud Integral UMSI
San Nicolás de los Garza, Nuevo León, 66465, Mexico
Unidad de Investigacion CIMA SC
Chihuahua City, 31200, Mexico
CICC Morelia
Morelia, Mexico
VU Medisch Centrum
Amsterdam, 1081 HV, Netherlands
Sint Antonius Ziekenhuis, locatie Nieuwegein
Nieuwegein, 3430 EM, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3000 CA, Netherlands
Auckland City Hospital
Auckland, 1023, New Zealand
NZ Respiratory & Sleep Institute
Auckland, 1051, New Zealand
University of Otago, Christchurch
Christchurch, 8011, New Zealand
Waikato Hospital; Gastro Research
Hamilton, 3240, New Zealand
Tauranga Hospital
Tauranga, 3143, New Zealand
Helse Bergen HF Haukeland universitetssykehus
Bergen, 5053, Norway
Akershus universitetssykehus
Lørenskog, 1478, Norway
Oslo University Hospital HF, Rikshospitalet
Oslo, 0424, Norway
Centrum Medycyny Oddechowej Mroz sp. j.
Bia?ystok, 15-044, Poland
Nasz Lekarz Osrodek Badan Klinicznych
Bydgoszcz, 85-312, Poland
Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii
Lodz, 90-153, Poland
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
Braga, 4710-243, Portugal
Centro Hospitalar Algarve
Faro, 8000-386, Portugal
Hospital Senhora da Oliveira ? Guimarães, E.P.E
Guimarães, 4835-044, Portugal
Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4099-001, Portugal
Hospital de Sao Joao; Centro de Investigacao
Porto, 4200-319, Portugal
Hospital de Santa Luzia
Porto, 4904-858, Portugal
CHVNG/E_Unidade 1; Servico de Pneumologia
Vila Nova de Gaia, 4434-502, Portugal
Singapore General Hospital
Singapore, 169608, Singapore
Tan Tock Seng Hospital; Oncology
Singapore, 308433, Singapore
University of Cape Town Lung Institute; Lung Clinical Research
Cape Town, 7700, South Africa
Vergelegen Medi-Clinic
Somerset West, 7130, South Africa
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, 420-767, South Korea
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do, 14662, South Korea
Gacheon University Gil Medical Center
Namdong-gu, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology
Seoul, (0)7345, South Korea
Seoul National University Hospital (SNUH) - Medical Oncology Center
Seoul, 03080, South Korea
Soonchunhyang University Hospital
Seoul, 04401, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
The Catholic University of Korea Seoul St. Mary?s Hospital
Seoul, 6591, South Korea
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, 01009, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Parc Taulí Sabadell Hospital Universitari
Sabadell, Barcelona, 8208, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Universitario del Henares
Coslada, Madrid, 28850, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28220, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, 28223, Spain
Universidad de Navarra - Clinica Universitaria de Navarra (CUN)
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario de Canarias
S. Cristobal de La Laguna, Tenerife, 38320, Spain
Hospital Galdakao-Usansolo
Galdakao, Vizcaya, 48960, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia
Barcelona, 08025, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Virgen de las Nieves; Servicio de Neumologia
Granada, 18014, Spain
Hospital Universitario de La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 280146, Spain
Clínica Universidad de Navarra ? Madrid
Madrid, 28027, Spain
Hospital Ramón y Cajal;Servicio de Neumología
Madrid, 28034, Spain
Hosp. Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario Fundacion Jimenez Diaz.
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Arnau de Vilanova (Valencia)
Valencia, 46015, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Skånes universitetssjukhus Malmö
Malmo, 214 28, Sweden
Inselspital Bern Universitätsklinik für Pneumologie
Bern, 3010, Switzerland
Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)
Neuchâtel, 2000, Switzerland
Buddhist Tzu Chi Dalin General Hospital; Rheumatology
Chiayi City, 622, Taiwan
Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital
Kaoshiung City, 807, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
National Cheng Kung University Hospital
Tainan, 70457, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Far Eastern Memorial Hospital; Department of Clinical Pathology
Taipei, 220, Taiwan
Veterans General Hospital - Taichung
Xitun Dist., 40705, Taiwan
Istanbul Universitesi Onkoloji Enstitüsü Hastanesi
?stanbul, 34093, Turkey (Türkiye)
Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali
Adana, 1330, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
Ankara, 06620, Turkey (Türkiye)
Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi
Bursa, 16059, Turkey (Türkiye)
Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, Turkey (Türkiye)
Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari
Istanbul, 34020, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul University Faculty of Medicine; Chest Diseases
Izmir, 35340, Turkey (Türkiye)
Erciyes Üniversitesi T?p Fakültesi
Kayseri, 38039, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Marmara Universitesi Hastanesi Marmara University Hospital
Maltepe, 34854, Turkey (Türkiye)
Mersin Üniversitesi Tip Fakültesi
Mersin, 33110, Turkey (Türkiye)
Akdeniz University Faculty of Medicine Department of Pulmonology
Muratpasa/Antalya, 07059, Turkey (Türkiye)
Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
Sarıyer, 34450, Turkey (Türkiye)
Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council
Dnipro, Katerynoslav Governorate, 49069, Ukraine
National Academy of Medical Science of Ukraine (NAMS); NRCRM
Kyiv, KIEV Governorate, 03115, Ukraine
Yanovskyy Inst of Phth. & Pulm; Clinical-functional
Kyiv, 03680, Ukraine
Edinburgh Royal Infirmary; Respiratory Department
Edinburgh, EH16 4SA, United Kingdom
Royal Brompton Hospital; Respiratory Department
London, SW3 6NP, United Kingdom
Manchester University NHS Foundation Trust - Wythenshawe Hospital
Manchester, M23 9LT, United Kingdom
North Manchester General Hospital
Manchester, M8 5RB, United Kingdom
Related Publications (3)
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.
PMID: 39761005DERIVEDRicheldi 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.
PMID: 38354066DERIVEDMantovani 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.
PMID: 36724330DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early based on the futility analysis which concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2020
First Posted
September 17, 2020
Study Start
March 19, 2021
Primary Completion
February 10, 2023
Study Completion
February 10, 2023
Last Updated
April 18, 2024
Results First Posted
April 18, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
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).