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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001429-30 | 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 study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).
This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zinpentraxin Alfa | Experimental | Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRM-151 (Zinpentraxin Alfa) | Drug | Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks. Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0. | From baseline until 8 weeks after the final dose, an average of 6 months |
| Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest | IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion. | From baseline until 8 weeks after the final dose, an average of 6 months |
| Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs | From baseline until 8 weeks after the final dose, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Rate of Change in Forced Vital Capacity (FVC) (mL) | From baseline until study completion (up to approximately 1.5 years) | |
| Annual Rate of Change in 6-Minute Walk Distance (6MWD) | From baseline until study completion (up to approximately 1.5 years) |
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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 | ||
| University of California Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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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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Participants were enrolled across 48 investigative sites in 16 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Zinpentraxin Alfa | Participants entered this Cohort following participation in study PRM-151-202. |
| FG001 | Cohort B: Ex-Placebo | Participants entered, following participation in study WA42293. |
| 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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|
| Annual Rate of Change in FVC% Predicted | From baseline until study completion (up to approximately 1.5 years) |
| Change in Carbon Monoxide Diffusing Capacity (DLCO) | At Baseline, Week 24 and Week 48 |
| Time to Disease Progression | Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death | From baseline until study completion (up to approximately 1.5 years) |
| Survival | Every 6 Months and at study completion (up to approximately 1.5 years) |
| IPF-related Mortality | Every 6 Months and at study completion (up to approximately 1.5 years) |
| Respiratory-related Mortality | Every 6 Months and at study completion (up to approximately 1.5 years) |
| Plasma Concentrations of PRM-151 at Specified Timepoints | Due to early termination of the study, only participants enrolled in Cohort A receiving at least one IV dose of zinpentraxin alfa had their plasma concentrations analyzed. | Days 1 and 5, Weeks 4, and 12 |
| Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline | Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed. | Baseline (Day 1) |
| Percentage of Participants With ADAs During the Study | Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed. | Weeks 4, 12 and 24 |
| 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 |
| 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 Health Pulmonology - Jacksonville | Jacksonville | Florida | 32209 | United States |
| Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | 33470-9216 | United States |
| Sarasota County Public Hospital | Sarasota | Florida | 34239 | United States |
| Renstar Medical Research | Wesley Chapel | Florida | 33544 | United States |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | 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 |
| 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 |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| Pulmonix Research | Greensboro | North Carolina | 27403-1127 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Jefferson University Physicians (JUP) - Jefferson Pulmonary | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | 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 |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | United States |
| Metroplex Pulmonology & Sleep Center | McKinney | Texas | 75069 | United States |
| University Of Utah Hosp & Clin; Investigational Pharmacy | Salt Lake City | Utah | 84132 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22031 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23219-1901 | 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 |
| Hospital Universitario Austral | Derqui-Pilar | B1629ODT | 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 |
| Instituto Medico de la Fundacion Estudios Clinicos | Rosario | S2000DEJ | 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 |
| Monash Medical Centre; Medicine | Melbourne | Victoria | 3186 | Australia |
| The Alfred Hospital | Prahan | Victoria | 3181 | Australia |
| 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 |
| Synergy Respiratory Care | Sherwood Park | Alberta | T8H ON2 | Canada |
| Kelowna Respiratory and Allergy Clinic | Kelowna | British Columbia | V1W 1V3 | Canada |
| The Rhema Research Institute | Owen Sound | Ontario | N4K 6M9 | Canada |
| Dr. Syed Anees Medicine Profession Corporation | Windsor | Ontario | N8X 1T3 | Canada |
| C.I.C. Mauricie | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| Beijing Friendship Hospital Affiliated of Capital University of Medical Science | Beijing | 100050 | China |
| Peking Union Medical College Hospital; Pharmacy | Beijing | 100730 | China |
| The Second Xiangya Hospital of Central South University | Changsha | 410011 | China |
| The Third Xiangya Hospital Of Central South University | Changsha | 410013 | 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 |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| Fakultni nemocnice Brno | Brno | 613 00 | Czechia |
| Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie | Hradec Králové | 500 05 | Czechia |
| Thomayerova nemocnice; Lekarna - pavilon H | Prague | 140 00 | Czechia |
| Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni | Zlín | 760 01 | Czechia |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Odense Universitetshospital | Odense C | 5000 | Denmark |
| 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 |
| CHU Hopitaux de Bordeaux | CHU Hopitaux de Bordeaux | 33000 | 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 Nice - Hôpital Pasteur 2 | Nice | 06000 | France |
| Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie | Paris | 75018 | France |
| Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche | Reims | 51092 | France |
| Centre Hospitalier Universitaire de Rennes | Rennes | 35033 | France |
| CHU Tours - Hôpital Bretonneau | Tours | 37044 | France |
| Evang. Lungenklinik Berlin Klinik für Pneumologie | Berlin | 13125 | Germany |
| Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik | Heidelberg | 69126 | Germany |
| Lungenfachklinik Immenhausen | Immenhausen | 34376 | 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; Endocrinology, Diabetes & Metabolism | Athens | 10676 | 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 |
| Athens Medical Center | Marousi | 151 25 | Greece |
| University of Thessaly Faculty of Medicine | Mezourlo | 41110 | 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 |
| Edith Wolfson Medical Center | Holon | 5822012 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Hadassah Medical Center | Jerusalem | 9112000 | 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 Neurology | Tel Aviv | 6423906 | 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 |
| "AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia " | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliera Universitaria Federico II | 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 |
| 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 |
| 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. 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 |
| 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 Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1 | 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 |
| 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; Hudavdelingen | Bergen | 5021 | 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 |
| SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | 90-153 | Poland |
| Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E) | Braga | 4710-243 | Portugal |
| Centro Hospitalar do Alto Ave; EPE | Guimarães | 4835-044 | Portugal |
| Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente | Lisbon | 1769-001 | Portugal |
| CHVNG/E_Unidade 1; Servico de Pneumologia | Vila Nova de Gaia | 4434-502 | Portugal |
| National University Hospital | Singapore | 117599 | Singapore |
| 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 |
| 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 |
| HUA - Txagorritxu | Vitoria-Gasteiz | Alava | 01009 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Corporació Sanitaria Parc Taulí; Servicio de Neurología | Sabadell | Barcelona | 08208 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| CHUS H Clinico U de Santiago | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Universitario del Henares | Coslada | Madrid | 28850 | Spain |
| Hospital Univ. Central de Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Galdakao-Usansolo | Galdakao | Vizcaya | 48960 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia | Barcelona | 08025 | Spain |
| Hospital Clinic I Provincial | 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; Servicio de Aparato Digestivo | Madrid | 28006 | Spain |
| Clinica Universidad de Navarra ; Servicio de Farmacia | Madrid | 28027 | Spain |
| Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz | Madrid | 28029 | Spain |
| Hospital Ramón y Cajal;Servicio de Neumología | Madrid | 28034 | Spain |
| Fundacion Jimenez Diaz-UTE | Madrid | 28040 | Spain |
| Hosp. Clinico San Carlos | 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 Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| 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 Tip Fakultesi | Gaziantep | 27310 | Turkey (Türkiye) |
| Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi | 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) |
| Kocaeli Universitesi Tip Fakultesi | Kocaeli | 41380 | Turkey (Türkiye) |
| Marmara Universitesi Hastanesi Marmara University Hospital | Maltepe | 34854 | Turkey (Türkiye) |
| Eriyes universitesi T?p Fakultesi Hastanesi | Melikgazi/Kayser | 38039 | Turkey (Türkiye) |
| Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi | 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) |
| FG002 | Cohort B: Zinpentraxin Alfa | Participants entered, following participation in study WA42293. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Zinpentraxin Alfa | Participants entered this Cohort following participation in study PRM-151-202. |
| BG001 | Cohort B: Ex-Placebo | Participants entered, following participation in study WA42293. |
| BG002 | Cohort B: Zinpentraxin Alfa | Participants entered, following participation in study WA42293. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0. | The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug. | Posted | Count of Participants | Participants | From baseline until 8 weeks after the final dose, an average of 6 months |
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| Primary | Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest | IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion. | The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug. | Posted | Count of Participants | Participants | From baseline until 8 weeks after the final dose, an average of 6 months |
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| Primary | Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs | The safety-evaluable population included all enrolled participants who received at least one administration (full or partial dose) of study drug. | Posted | Count of Participants | Participants | From baseline until 8 weeks after the final dose, an average of 6 months |
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| Secondary | Annual Rate of Change in Forced Vital Capacity (FVC) (mL) | The full analysis set included all enrolled participants who received at least one administration (full or partial dose) of study drug. | Posted | Mean | 95% Confidence Interval | Milliliter (mL) | From baseline until study completion (up to approximately 1.5 years) |
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| Secondary | Annual Rate of 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 until study completion (up to approximately 1.5 years) |
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| Secondary | Annual Rate of 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 until study completion (up to approximately 1.5 years) |
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| 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. In the Ex-placebo arm, no participant was assessed for DLCO after baseline. Due to short length of follow-up, no DLCO assessment was collected at Week 48 for Cohort B: Zinpentraxin Alfa arm. | Posted | Mean | Standard Deviation | DLCO% Predicted | At Baseline, Week 24 and Week 48 |
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| Secondary | Time to Disease Progression | Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death | 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 until study completion (up to approximately 1.5 years) |
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| Secondary | Survival | 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 | Every 6 Months and at study completion (up to approximately 1.5 years) |
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| Secondary | IPF-related 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 | Every 6 Months and at study completion (up to approximately 1.5 years) |
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| Secondary | Respiratory-related 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 | Every 6 Months and at study completion (up to approximately 1.5 years) |
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| Secondary | Plasma Concentrations of PRM-151 at Specified Timepoints | Due to early termination of the study, only participants enrolled in Cohort A receiving at least one IV dose of zinpentraxin alfa had their plasma concentrations analyzed. | The pharmacokinetic 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 and 5, Weeks 4, and 12 |
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| Secondary | Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline | Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed. | 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. | Posted | Number | Participants | Baseline (Day 1) |
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| Secondary | Percentage of Participants With ADAs During the Study | Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed. | 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. | Posted | Number | Percentage of Participants | Weeks 4, 12 and 24 |
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AEs were assessed from baseline until 8 weeks after the final dose, an average of 6 months. Deaths were assessed for up to 1.5 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Cohort A Zinpentraxin Alfa | Participants entered this Cohort following participation in study PRM-151-202. | 0 | 21 | 5 | 21 | 14 | 21 |
| EG001 | Cohort B Ex-Placebo | Participants entered, following participation in study WA42293. | 2 | 49 | 8 | 49 | 16 | 49 |
| EG002 | Cohort B Zinpentraxin Alfa | Participants entered, following participation in study WA42293. | 2 | 47 | 6 | 47 | 14 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 25.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 25.1 | Systematic Assessment |
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| Duodenal ulcer | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Death | General disorders | MedDRA version 25.1 | Systematic Assessment |
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| Vascular stent thrombosis | General disorders | MedDRA version 25.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA version 25.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Hypovolaemic shock | Vascular disorders | MedDRA version 25.1 | Systematic Assessment |
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| Microscopic polyangiitis | Vascular disorders | MedDRA version 25.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 25.1 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA version 25.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 25.1 | Systematic Assessment |
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| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA version 25.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 25.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 25.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 25.1 | Systematic Assessment |
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This study was terminated early due to the Sponsor's decision to terminate the parent study early.
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 | Aug 24, 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 |
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| ID | Term |
|---|---|
| C552898 | PRM-151 |
Not provided
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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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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| Participants |
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