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

Idiopathic Pulmonary Fibrosis Clinical Trial

— STARSCAPE  

Official title:

A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04552899
• Other study ID #: WA42293
• Secondary ID: 2020-000791-38
• Status: Terminated
• Phase: Phase 3
• Start date: March 19, 2021
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 665
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) Clinical Practice Guideline

• High-resolution computed tomography (HRCT) pattern consistent with the diagnosis of IPF, confirmed by central review of Chest HRCT and central review of any available lung biopsy (LB)

• Minimum 6 minute walk distance (6MWD) of 150 meters with maximum use of 6 L/min at sea-level and up-to 8 L/min at altitude of supplemental oxygen while maintaining oxygen saturation of greater than or equal to (>/= )83% during the 6 minute walk test (6MWT) during screening

• FVC >/= 45% predicted during screening as determined by the over-reader

• Forced expiratory volume in 1 second (FEV1)/FVC ratio greater than (>) 0.70 during screening determined by the over-reader

• Diffusing capacity for carbon monoxide (DLCO) >/= 30% and less than or equal to (</=) 90% of predicted at screening as determined by the over-reader

• If receiving pirfenidone or nintedanib treatment for IPF, the participant must have been on treatment for at least 3 months and a stable dose for at least 4 weeks prior to screening, and during screening

• If not currently receiving nintedanib or pirfenidone treatment (either treatment naïve or having previously taken and discontinued) must have discontinued such treatment >/= 4 weeks prior to screening and during screening

• Anticipated life expectancy of at least 12 months at baseline

• Participant and investigator considered all medicinal treatment options and/or possibly lung transplantation prior to considering participation in the study.

• For women of childbearing potential (excluding participant enrolling in Japan):

agreement to remain abstinent or use contraception

• For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm

• Anticipated life expectancy of at least 12 months at baseline, according to the investigator's judgment

• For participant enrolled in the extended China enrollment phase: current resident of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

Exclusion Criteria:

• Evidence of other known causes of Interstitial Lung Disease (ILD)

• FVC% predicted value showing repeated increase in the 6 months period prior to screening and including screening value

• Emphysema present on greater than or equal to (>/=) 50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT

• Receiving nintedanib in combination with pirfenidone

• Received cytotoxic, immunosuppressive, cytokine modulating, or receptor antagonist agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine or other steroid sparing agent) within 4 weeks prior to or during screening

• Receiving systemic corticosteroids equivalent to prednisone > 10 mg/day or equivalent within 2 weeks prior to or during screening

• Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening and not successfully resolved 4 weeks prior to screening visit

• Participants with active or latent tuberculosis (confirmed within the 6 months prior to or during screening, by a positive screening test [interferon gamma release assay])

• Resting oxygen saturation of < 89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (>/= 5000 feet [1524 meters] above sea level) during screening

• Class IV New York Heart Association chronic heart failure

• Historical evidence of left ventricular ejection fraction < 35%

• Presence of pulmonary hypertension that, in the investigator's opinion, would substantially limit the ability to comply with study requirements or may influence any of the safety or efficacy assessments included in the study

• Cardiopulmonary rehabilitation program based on exercise training that has been completed within 8 weeks prior to screening or planned to start during the participant enrollment in this trial

• History of smoking, alcohol or substance abuse disorder, or a malignancy

• Previous treatment with PRM-151

• Clinically significant abnormality on ECG during screening that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) on ECG during screening based on the Fridericia correction formula

• Clinically significant laboratory test abnormalities during screening (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant

• Pregnant or breastfeeding, or become pregnant during the study or within 8 weeks after the final dose of PRM-151

• Women of childbearing potential (Only for participants enrolling in Japan)

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• PRM-151 (Zinpentraxin Alfa)
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
• Placebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

Locations

Country	Name	City	State
Argentina	Fundacion Respirar (Centro Medico Dra. De Salvo)	Ciudad Autonoma Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility	Córdoba
Argentina	Centro Medico de Enfermedades Respiratorias (CEMER)	Florida, Buenos Aires
Argentina	Centro de estudios respiratorios	Mar Del Plata
Argentina	Fundacion Scherbovsky	Mendoza
Argentina	INSARES	Mendoza, Mendoza City
Argentina	Investigaciones en Patologias Respiratorias	San Miguel de Tucuman
Australia	The Queen Elizabeth Hospital	Adelaide	South Australia
Australia	Cairns Base Hospital; Cancer Care Centre	Cairns	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Austin Hospital; Cancer Clinical Trials Centre	Melbourne	Victoria
Australia	Monash Medical Centre; Medicine	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Lung Research Queensland	Nundah	Queensland
Australia	The Alfred Hospital	Prahan	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung	Klagenfurt
Austria	Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie	Salzburg
Belgium	ULB Hôpital Erasme	Brussels
Belgium	Cliniques Universitaires Saint-Luc; Pharmacy	Bruxelles
Belgium	UZ Leuven	Leuven
Belgium	C. H. U. Sart-Tilman; Laboratory	Liège
Belgium	CHU UCL Namur / site Godinne	Yvoir
Brazil	Hospital das Clinicas - UFMG	Belo Horizonte	MG
Brazil	Santa Casa de Misericordia de Porto Alegre	Porto Alegre	RS
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Kelowna Respiratory and Allergy Clinic	Kelowna	British Columbia
Canada	Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital	Montreal	Quebec
Canada	McGill University, Montreal Chest Institute; Viral and other Infectious	Montreal	Quebec
Canada	The Rhema Research Institute	Owen Sound	Ontario
Canada	Synergy Respiratory Care	Sherwood Park	Alberta
Canada	Eastern Health - General Hospital	St. John's	Newfoundland and Labrador
Canada	C.I.C. Mauricie	Trois-Rivières	Quebec
Canada	Vancouver General Hospital; Gordon and Leslie Diamond Health Care	Vancouver	British Columbia
Canada	Dr. Syed Anees Medicine Profession Corporation	Windsor	Ontario
China	Peking University Third Hospital	Beijing
China	China-Japan Friendship Hospital	Beijing City
China	CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine	Beijing City
China	Peking Union Medical College Hospital; Pharmacy	Beijing City
China	Beijing Friendship Hospital Affiliated of Capital University of Medical Science	Beijing Shi
China	The Second Xiangya Hospital of Central South University	Changsha
China	The Third Xiangya Hospital Of Central South University	Changsha
China	Xiangya Hospital Central South University	Changsha City
China	West China Hospital, Sichuan University	Chengdu
China	Southern Medical University Nanfang Hospital	Guangdong Province Guangzhou City
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	The First Affilicated Hospital, Sun Yat-sen University	Guangzhou City
China	1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy	Hangzhou City
China	Inner Mongolia Autonomous Region People's Hospital	Hohhot City
China	Qilu Hospital of Shandong University	Jinan
China	The 1st Affiliated Hospital of Nanchang Unversity	Nanchang City
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City
China	Ningbo First Hospital	Ningbo City
China	Huadong Hospital Affiliated to Fudan University	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai City
China	Shengjing Hospital of China Medical University	ShenYang
China	China Medical University (CMU) First Affiliated Hospital	Shenyang City
China	Hebei Medical University - The Second Hospital	Shijiazhuang City
China	Tianjin Medical University General Hospital	Tianjin
China	Tongji Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan City
China	Wuxi People's Hospital	Wuxi
China	Tangdu Hospital, The Fourth Military Medical University; Neurology Department	Xi'an City
China	Qinghai Provincial People?s Hospital	Xining City
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital	Zhengzhou City
Czechia	Fakultní Nemocnice Brno	Brno
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie	Plzen
Czechia	Nemocnice Na Bulovce	Prague
Czechia	Thomayerova nemocnice; Lekarna - pavilon H	Praha 4
Czechia	Krajská nemocnice T. Bati, a. s.	Zlín
Denmark	Aarhus Universitetshospital Skejby	Aarthus N
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense Universitetshospital	Odense C
Finland	Turku University Hospital	Turku
France	Hopital Avicenne	Bobigny
France	Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche	Brest
France	Hopital Louis Pradel	Bron
France	Hospital d Instructions des Armees Percy	Clamart
France	CHU Dijon Bourgogne Hôpital François Mitterand	Dijon
France	CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie	La Tronche
France	Centre Hospitalier Regional Universitaire de Lille	Lille
France	Servie de Pneumologie et centre de Transplantation Pulmonaire	Marseille
France	CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique	Montpellier
France	CHU Nice - Hôpital Pasteur 2	Nice
France	European Hospital Georges Pompidou (HEGP)	Paris
France	Hopital Bichat Claude Bernard; CIC	Paris
France	Hopital Haut Leveque	Pessac
France	Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche	Reims
France	CHU de Rennes - Hopital de Pontchaillo	Rennes
France	CHU Tours - Hôpital Bretonneau; Pharmacie	Tours
Germany	Zentralklinik Bad Berka GmbH; Pneumologie	Bad Berka
Germany	Evang. Lungenklinik Berlin Klinik für Pneumologie	Berlin
Germany	Universitatsklinikum Essen; Innere Klinik	Essen
Germany	IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie	Frankfurt am Main
Germany	Universitatsklinikum Gießen und Marburg GmbH	Gießen
Germany	Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie	Hannover
Germany	Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik	Heidelberg
Germany	Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde	Homburg/Saar
Germany	Lungenfachklinik Immenhausen	Immenhausen
Germany	Universitatsklinikum Leipzig; Apotheke	Leipzig
Germany	IKF Pneumologie Mainz Helix Medical Excellence Center Mainz	Mainz
Germany	Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup	Marburg
Germany	Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken	Münnerstadt
Germany	Krankenhaus Bethanien gGmbH	Solingen
Greece	Evangelismos Hospital; Department of Critical Care and Pulmonary Services	Athens
Greece	Attikon University General Hospital	Chaidari
Greece	University General Hospital of Heraklion	Heraklio
Greece	University Hospital of Ioannina; Pulmonology Department	Ioannina
Greece	Hospital is University General Hospital of Larissa	Larissa
Greece	Athens Medical Center	Marousi
Greece	University General Hospital of Patras	Patras
Greece	"General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "	Sotiria Athens
Greece	General Hospital of Thessaloniki G. Papanikolaou	Thessaloniki
Hong Kong	Prince of Wales Hospital; Dept. of Medicine & Therapeutics	Hong Kong
Hong Kong	The University of Hong Kong; Queen Mary Hospital	Hong Kong
Hungary	Semmelweis University	Budapest
Hungary	Debreceni Egyetem	Debrecen
Hungary	Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET	Szombathely
Hungary	Szent Borbala Korhaz	Tatabánya
Hungary	Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum	Törökbálint
Israel	Barzilai Medical Center; Neurology Department	Ashkelon
Israel	Shamir medical center	Be'er Ya'akov
Israel	Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute	Beer sheva
Israel	Bnai Zion Medical Center; Internal Medicine	Haifa
Israel	Carmel Medical Center; Obstetrics and Gynecology	Haifa
Israel	Rambam Health Care Campus	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center; Nrphrology Dept.	Jerusalem
Israel	Meir Medical Center	Kfar- Saba
Israel	Rabin Medical Center	Petach Tiqwa
Israel	The Chaim Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Israel	Tel-Aviv Sourasky Medical Center; Department of Pulmonary	Tel Aviv
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo	Abruzzo
Italy	Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele	Catania	Sicilia
Italy	AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2	Firenze	Toscana
Italy	Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia	Foggia	Puglia
Italy	Ospedale Morgagni Pierantoni; Patologia clinica	Forlì	Emilia-Romagna
Italy	"Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "	Garbagnate Milanese	Lombardia
Italy	Asst Santi Paolo E Carlo	Milano	Lombardia
Italy	Ospedale San Giuseppe; U.O. di Pneumologia	Milano	Lombardia
Italy	A.O.U. Policlinico di Modena	Modena	Emilia-Romagna
Italy	Ospedale San Gerardo	Monza	Lombardia
Italy	AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico	Napoli	Campania
Italy	Azienda Ospedaliera Dei Colli	Napoli	Campania
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli	Campania
Italy	Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche	Napoli	Campania
Italy	A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone	Orbassano (to)	Piemonte
Italy	Ospedale di Ostuni - Pneumologia	Ostuni	Puglia
Italy	Azienda Ospedale Università Di Padova; Clinica Pneumologica	Padova	Veneto
Italy	Az. Osp. Univ. P. Giaccone; UOC di Pneumologia	Palermo	Sicilia
Italy	Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia	Palermo	Sicilia
Italy	Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia	Pavia	Lombardia
Italy	Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia	Rome	Lazio
Italy	Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio	Rome	Lazio
Italy	A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale	Sassari	Sardegna
Italy	A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche	Siena	Toscana
Italy	Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette	Torino	Piemonte
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti	Torrette Di Ancona	Marche
Italy	University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center	Treviso	Veneto
Italy	Azienda Sanitaria Universitaria Integrata di Trieste	Trieste	Friuli-Venezia Giulia
Japan	Nagoya University Hospital	Aichi
Japan	Chiba University Hospital	Chiba
Japan	Fukuoka University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Kobe City Medical Center General Hospital	Hyogo
Japan	National Hospital Organization Himeji Medical Center	Hyogo
Japan	Kameda Medical Center	Kamogawa
Japan	Kanagawa Cardiovascular and Respiratory Center	Kanagawa
Japan	Nippon Medical School Musashi Kosugi Hospital	Kawasaki-Shi
Japan	Saiseikai Kumamoto Hospital	Kumamoto-Shi
Japan	Nagasaki University Hospital	Nagasaki
Japan	National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research	Naka-gun
Japan	Kurashiki Central Hospital	Okayama
Japan	National Hospital Organization Kinki-Chuo Chest Medical Center	Sakai-shi
Japan	Tosei General Hospital	Seto-shi
Japan	Tenri Hospital	Tenri-Shi
Japan	Jichi Medical University Hospital	Tochigi
Japan	Tokushima University Hospital	Tokushima
Japan	Center Hospital of the National Center for Global Health and Medicine	Tokyo
Japan	Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology	Tokyo
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon-si,
Korea, Republic of	The Catholic University of Korea Bucheon St. Mary's Hospital	Gyeonggi-do
Korea, Republic of	Gacheon University Gil Medical Center	Namdong-gu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital (SNUH) - Medical Oncology Center	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary?s Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology	Seoul
Mexico	Unidad de Investigacion CIMA SC	Chihuahua
Mexico	INER- Instituto Nacional de Enfermedades Respiratorias"Ismae	Ciudad de México	Mexico CITY (federal District)
Mexico	Centro Respiratorio de México	Mexico	Mexico CITY (federal District)
Mexico	CICC Morelia	Morelia
Mexico	Unidad Médica para la Salud Integral UMSI	San Nicolás de Los Garza	Nuevo LEON
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	Sint Antonius Ziekenhuis, locatie Nieuwegein	Nieuwegein
Netherlands	Erasmus Medisch Centrum	Rotterdam
New Zealand	Auckland City Hospital	Auckland
New Zealand	NZ Respiratory & Sleep Institute	Auckland
New Zealand	University of Otago, Christchurch	Christchurch
New Zealand	Waikato Hospital; Gastro Research	Hamilton
New Zealand	Tauranga Hospital	Tauranga
Norway	Helse Bergen HF Haukeland universitetssykehus	Bergen
Norway	Akershus universitetssykehus	Lørenskog
Norway	Oslo University Hospital HF, Rikshospitalet	Oslo
Poland	Centrum Medycyny Oddechowej Mroz sp. j.	Bia?ystok
Poland	Nasz Lekarz Osrodek Badan Klinicznych	Bydgoszcz
Poland	Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii	Lodz
Portugal	Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)	Braga
Portugal	Centro Hospitalar Algarve	Faro
Portugal	Hospital Senhora da Oliveira ? Guimarães, E.P.E	Guimaraes
Portugal	Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente	Lisboa
Portugal	Centro Hospitalar do Porto - Hospital de Santo António	Porto
Portugal	Hospital de Santa Luzia	Porto
Portugal	Hospital de Sao Joao; Centro de Investigacao	Porto
Portugal	CHVNG/E_Unidade 1; Servico de Pneumologia	Vila Nova de Gaia
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital; Oncology	Singapore
South Africa	University of Cape Town Lung Institute; Lung Clinical Research	Cape Town
South Africa	Vergelegen Medi-Clinic	Somerset West
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Vall d?Hebron Institute of Oncology (VHIO), Barcelona	Barcelona
Spain	Hospital Universitario del Henares	Coslada	Madrid
Spain	Hospital Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Hospital Virgen de las Nieves; Servicio de Neumologia	Granada
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Clínica Universidad de Navarra ? Madrid	Madrid
Spain	Hosp. Clinico San Carlos	Madrid
Spain	Hospital Ramón y Cajal;Servicio de Neumología	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz.	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Universidad de Navarra - Clinica Universitaria de Navarra (CUN)	Pamplona	Navarra
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Madrid
Spain	Hospital Universitario de Canarias	S. Cristobal De La Laguna	Tenerife
Spain	Parc Taulí Sabadell Hospital Universitari	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Arnau de Vilanova (Valencia)	Valencia
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Txagorritxu	Vitoria-Gasteiz	Alava
Sweden	Skånes universitetssjukhus Malmö	Malmö
Switzerland	Inselspital Bern Universitätsklinik für Pneumologie	Bern
Switzerland	Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)	Neuchâtel
Taiwan	Buddhist Tzu Chi Dalin General Hospital; Rheumatology	Chia-yi
Taiwan	Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital	Kaoshiung City
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Far Eastern Memorial Hospital; Department of Clinical Pathology	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Veterans General Hospital - Taichung	Xitun Dist.
Turkey	Istanbul Universitesi Onkoloji Enstitüsü Hastanesi	?stanbul
Turkey	Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali	Adana
Turkey	Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi	Ankara
Turkey	Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi	Bursa
Turkey	Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi	Gaziantep
Turkey	Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari	Istanbul
Turkey	Dokuz Eylul University Faculty of Medicine; Chest Diseases	Izmir
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Erciyes Üniversitesi T?p Fakültesi	Kayseri
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Marmara Universitesi Hastanesi Marmara University Hospital	Maltepe
Turkey	Mersin Üniversitesi Tip Fakültesi	Mersin
Turkey	Akdeniz University Faculty of Medicine Department of Pulmonology	Muratpasa/Antalya
Turkey	Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)	Sariyer
Ukraine	Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council	Dnipro	Katerynoslav Governorate
Ukraine	National Academy of Medical Science of Ukraine (NAMS); NRCRM	Kyiv	KIEV Governorate
Ukraine	Yanovskyy Inst of Phth. & Pulm; Clinical-functional	Kyiv
United Kingdom	Edinburgh Royal Infirmary; Respiratory Department	Edinburgh
United Kingdom	Royal Brompton Hospital; Respiratory Department	London
United Kingdom	Manchester University NHS Foundation Trust - Wythenshawe Hospital	Manchester
United Kingdom	North Manchester General Hospital	Manchester
United States	Emory University	Atlanta	Georgia
United States	University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)	Aurora	Colorado
United States	Piedmont Healthcare Pulmonary and Critical Care Research	Austell	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham & Women'S Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Meris Clinical Research	Brandon	Florida
United States	Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration	Celebration	Florida
United States	Medical University of South Carolina Hospital	Charleston	South Carolina
United States	American Health Research Inc.	Charlotte	North Carolina
United States	The Lung Research Center	Chesterfield	Missouri
United States	University of Cincinnati Cancer Institute	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Horizon Clinical Research Group	Cypress	Texas
United States	Cardiopulmonary Research Science and Technology Institute	Dallas	Texas
United States	University of Texas Southwestern Medical Center; Heart and Lung Clinic	Dallas	Texas
United States	Advanced Pulmonary & Sleep Research Institute of Florida	Daytona Beach	Florida
United States	National Jewish Health Medical Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Inova Fairfax Hospital/IHVI; Cardiology	Falls Church	Virginia
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine	Gainesville	Florida
United States	University of Texas Medical Branch; Cardiology Department	Galveston	Texas
United States	Pulmonix Research	Greensboro	North Carolina
United States	Indiana Univ School of Med	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics; Investigational Drug Services	Iowa City	Iowa
United States	University of Florida Health Pulmonology - Jacksonville	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	DCOL Center for Clinical Research	Longview	Texas
United States	University of Louisville Health Sciences Center	Louisville	Kentucky
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Metroplex Pulmonology & Sleep Center	McKinney	Texas
United States	San Marcus Research Clinic Inc.	Miami	Florida
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Lenox Hill Hospital	New York	New York
United States	Lowcountry Lung and Critical Care	North Charleston	South Carolina
United States	Renstar Medical Research	Ocala	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	UC Irvine Medical Center	Orange	California
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	Stanford Hospital and Clinics	Palo Alto	California
United States	Jefferson University Physicians (JUP) - Jefferson Pulmonary	Philadelphia	Pennsylvania
United States	Temple University Medical Center	Philadelphia	Pennsylvania
United States	Banner University Medical Center Phoenix; Main Pharmacy	Phoenix	Arizona
United States	Lovelace Scientific Resources, Inc.	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	University of California Davis	Sacramento	California
United States	Covenant Medical Center - Cooper	Saginaw	Michigan
United States	Washington University	Saint Louis	Missouri
United States	University Of Utah Hosp & Clin; Investigational Pharmacy	Salt Lake City	Utah
United States	Audie L. Murphy VA Hospital, STVHCS	San Antonio	Texas
United States	Inst. of Healthcare Assessment, Inc.	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	Paloma Medical Group	San Juan Capistrano	California
United States	William Sansum Diabetes Center	Santa Barbara	California
United States	Sarasota Memorial Health Care System; Cancer Research Program	Sarasota	Florida
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Pulmonary & Allergy Associates	Summit	New Jersey
United States	University of South Florida	Tampa	Florida
United States	Mercy St. Vincent Medical Center	Toledo	Ohio
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Integral ? Clinical Trial Solutions	Weston	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Clinical Site Partners Orlando	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Forced Vital Capacity (FVC [mL])		From Baseline up to Week 52
Secondary	Absolute Change in 6-minute Walk Distance (6MWD)		From Baseline up to Week 52
Secondary	Absolute Change in FVC% Predicted		From Baseline up to Week 52
Secondary	Time to Disease Progression		From Baseline up to 1 year
Secondary	Time to First Respiratory-related Hospitalizations		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.	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.	At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary	Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)		From Baseline up to 1 year
Secondary	Change in Carbon Monoxide Diffusing Capacity (DLCO)		At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary	Survival	Survival is measured by all-cause mortality	From Baseline up to 1 year
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Plasma Concentrations of PRM-151		Days 1, 5 and Weeks 4, 12, and 24
Secondary	Prevalence of Anti-drug Antibodies (ADAs) at Baseline		At Baseline
Secondary	Percentage of Participants With ADAs During the Study		Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56