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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000791-38 | EudraCT Number |
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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.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinpentraxin Alfa | Experimental | Participants 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 Comparator | Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Forced Vital Capacity (FVC [mL]) | From Baseline up to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in 6-minute Walk Distance (6MWD) | From Baseline up to Week 52 | |
| Absolute Change in FVC% Predicted | From Baseline up to Week 52 | |
| Time to Disease Progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Banner University Medical Center Phoenix; Main Pharmacy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39761005 | Derived | 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. | |
| 38354066 |
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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).
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One participant who failed screening was enrolled in error and did not subsequently enter the study.
A total of 665 participants were enrolled across 275 investigative sites in 29 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zinpentraxin Alfa | Participants received 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 28, 2022 | Feb 2, 2024 |
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| Placebo | Drug | Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48. |
|
| 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) | 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. | At Baseline, Week 12, Week 24, Week 36 and Week 52 |
| 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. | At Baseline, Week 12, Week 24, Week 36 and Week 52 |
| Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | From Baseline up to 1 year |
| Change in Carbon Monoxide Diffusing Capacity (DLCO) | At Baseline, Week 12, Week 24, Week 36 and Week 52 |
| Survival | Survival is measured by all-cause mortality | From Baseline up to 1 year |
| Percentage of Participants With Adverse Events (AEs) | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) |
| Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) |
| Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) |
| Plasma Concentrations of PRM-151 | Days 1, 5 and Weeks 4, 12, and 24 |
| Prevalence of Anti-drug Antibodies (ADAs) at Baseline | At Baseline |
| Percentage of Participants With ADAs During the Study | Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 |
| 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 | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera Dei Colli | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | Campania | 80131 | Italy |
| Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche | Naples | 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 | Padova | 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 | Malmö | 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) | Sariyer | 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 |
| Derived |
| 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. |
| 36724330 | Derived | 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. |
Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
| No Treatment | Participants who were randomized but didn't receive any treatment. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The randomized population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zinpentraxin Alfa | Participants received 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. |
| BG001 | Placebo | Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absolute Change in Forced Vital Capacity (FVC [mL]) | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Mean | 95% Confidence Interval | Milliliters (mL) | From Baseline up to Week 52 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in 6-minute Walk Distance (6MWD) | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Mean | 95% Confidence Interval | Meters (m) | From Baseline up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in FVC% Predicted | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Mean | 95% Confidence Interval | Percent predicted | From Baseline up to Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Disease Progression | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Median | 95% Confidence Interval | Months | From Baseline up to 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Respiratory-related Hospitalizations | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Median | 95% Confidence Interval | Months | From Baseline up to 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline, Week 12, Week 24, Week 36 and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Mean | Standard Deviation | Score on a scale | At Baseline, Week 12, Week 24, Week 36 and Week 52 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Median | 95% Confidence Interval | Months | From Baseline up to 1 year |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Carbon Monoxide Diffusing Capacity (DLCO) | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Mean | Standard Deviation | DLCO% Predicted | At Baseline, Week 12, Week 24, Week 36 and Week 52 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Survival | Survival is measured by all-cause mortality | The full analysis set included all randomized participants who received at least one administration (full or partial dose) of study drug and used the grouping according to the treatment assignment at randomization. | Posted | Median | 95% Confidence Interval | Months | From Baseline up to 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | The safety population included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received. | Posted | Count of Participants | Participants | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | The safety population included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received. | Posted | Count of Participants | Participants | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | The safety population included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received. | Posted | Count of Participants | Participants | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of PRM-151 | The pharmacokinetic (PK) population included all randomized participants who received at least one administration (full or partial dose) of zinpentraxin alfa and at least one evaluable postdose PK sample that was above the lower limit of quantification (LLOQ). | Posted | Mean | Standard Deviation | micrograms per millilitre (ug/mL) | Days 1, 5 and Weeks 4, 12, and 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Prevalence of Anti-drug Antibodies (ADAs) at Baseline | The immunogenicity population included all randomized participants with at least one postdose ADA assessment and were grouped according to treatment received or, if no treatment is received prior to study discontinuation, according to treatment assigned. There is no data reported for the Placebo Arm as that group never received any study drug. As such, we cannot measure anti-drug antibodies for that group of participants. | Posted | Number | Participants | At Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ADAs During the Study | The immunogenicity population included all randomized participants with at least one postdose ADA assessment and were grouped according to treatment received or, if no treatment is received prior to study discontinuation, according to treatment assigned. There is no data reported for the Placebo Arm as that group never received any study drug. As such, we cannot measure anti-drug antibodies for that group of participants. | Posted | Count of Participants | Participants | Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 |
|
|
From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
All-cause mortality was reported based on randomized population =all randomized participants.
SAEs & other AEs reported based on safety-evaluable population which included all randomized participants who received at least one administration (full or partial dose) of study drug and were grouped according to the actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zinpentraxin Alfa | Participants received 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. | 4 | 331 | 46 | 331 | 140 | 331 |
| EG001 | Placebo | Participants received IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48. | 4 | 333 | 40 | 329 | 128 | 329 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Mesenteric artery embolism | Gastrointestinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 25.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA v 25.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Renal embolism | Renal and urinary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Renal infarct | Renal and urinary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Microscopic polyangiitis | Vascular disorders | MedDRA v 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v 25.1 | Systematic Assessment |
|
This study was terminated early based on the futility analysis which concluded that zinpentraxin alfa was unlikely to meet its primary endpoint.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2022 | Feb 2, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C552898 | PRM-151 |
Not provided
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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