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

Idiopathic Pulmonary Fibrosis Clinical Trial

— STARSCAPE-OLE  

Official title:

A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04594707
• Other study ID #: WA42294
• Secondary ID: 2020-001429-30
• Status: Terminated
• Phase: Phase 3
• Start date: August 30, 2021
• Est. completion date: February 10, 2023

Study information

• Verified date: March 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 117
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.

Exclusion Criteria:

• Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
• History of smoking within 3 months prior to the first visit in the OLE.
• History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
• History of severe allergic reaction or anaphylactic reaction to PRM-151.
• Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
• Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
• Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• PRM-151 (Zinpentraxin Alfa)
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.

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	Hospital Universitario Austral	Derqui-Pilar
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	Instituto Medico de la Fundacion Estudios Clinicos	Rosario
Argentina	Investigaciones en Patologias Respiratorias	San Miguel de Tucuman
Australia	Cairns Base Hospital; Cancer Care Centre	Cairns	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre; Medicine	Melbourne	Victoria
Australia	Lung Research Queensland	Nundah	Queensland
Australia	The Alfred Hospital	Prahan	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
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
Canada	Kelowna Respiratory and Allergy Clinic	Kelowna	British Columbia
Canada	The Rhema Research Institute	Owen Sound	Ontario
Canada	Synergy Respiratory Care	Sherwood Park	Alberta
Canada	C.I.C. Mauricie	Trois-Rivières	Quebec
Canada	Dr. Syed Anees Medicine Profession Corporation	Windsor	Ontario
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	Shengjing Hospital of China Medical University	ShenYang
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	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni Nemocnice; Interni Klinika - odd. Invazivni Kardiologie	Hradec Kralove
Czechia	Thomayerova nemocnice; Lekarna - pavilon H	Praha 4
Czechia	Krajska nemocnice T. Bati a.s.; Neurologicke oddeleni	Zlin
Denmark	Gentofte Hospital	Hellerup
Denmark	Odense Universitetshospital	Odense C
France	Hopital Avicenne	Bobigny
France	Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche	Brest
France	Hopital Louis Pradel	Bron
France	CHU Hopitaux de Bordeaux	CHU Hopitaux De Bordeaux
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 Nice - Hôpital Pasteur 2	Nice
France	Hopital Bichat Claude Bernard; Hepatologie Gastro Enterologie	Paris
France	Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche	Reims
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	CHU Tours - Hôpital Bretonneau	Tours
Germany	Evang. Lungenklinik Berlin Klinik für Pneumologie	Berlin
Germany	Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik	Heidelberg
Germany	Lungenfachklinik Immenhausen	Immenhausen
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; Endocrinology, Diabetes & Metabolism	Athens
Greece	Attikon University General Hospital	Chaidari
Greece	University General Hospital of Heraklion	Herakleion
Greece	University Hospital of Ioannina; Pulmonology Department	Ioannina
Greece	Athens Medical Center	Marousi
Greece	University of Thessaly Faculty of Medicine	Mezourlo
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	Rambam Health Care Campus	Haifa
Israel	Edith Wolfson Medical Center	Holon
Israel	Hadassah Medical Center	Jerusalem
Israel	Shaare Zedek Medical Center	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 Neurology	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 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	"AZIENDA OSPEDALIERA DEI COLLI Monaldi-Cotugno-CTO - Pneumologia "	Napoli	Campania
Italy	Azienda Ospedaliera Universitaria Federico II	Napoli	Campania
Italy	Azienda Ospedale Universita Di Padova; Divisione Clinicizzata Di Nefrologia 1	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	University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center	Treviso	Veneto
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	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 Yeouido St. Mary's Hospital; Hematology-Oncology	Seoul
Mexico	Unidad de Investigacion CIMA SC	Chihuahua
Mexico	Centro Respiratorio de México	Mexico
Mexico	INER- Instituto Nacional de Enfermedades Respiratorias"Ismae	Mexico
Mexico	CICC Morelia	Morelia
Mexico	Unidad Médica para la Salud Integral UMSI	San Nicolás de Los Garza	Nuevo LEON
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; Hudavdelingen	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	SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lodz
Portugal	Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)	Braga
Portugal	Centro Hospitalar do Alto Ave; EPE	Guimarães
Portugal	Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente	Lisboa
Portugal	CHVNG/E_Unidade 1; Servico de Pneumologia	Vila Nova de Gaia
Singapore	National University Hospital	Singapore
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 I Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia	Barcelona
Spain	Hospital Germans Trias i Pujol	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	Clinica Universidad de Navarra ; Servicio de Farmacia	Madrid
Spain	Fundacion Jimenez Diaz-UTE	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; Servicio de Aparato Digestivo	Madrid
Spain	Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria	Malaga
Spain	Hospital Univ. Central de Asturias	Oviedo	Asturias
Spain	Corporació Sanitaria Parc Taulí; Servicio de Neurología	Sabadell	Barcelona
Spain	Hospital Clinico Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	CHUS ? H. Clinico U. de Santiago	Santiago de Compostela	LA Coruña
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	HUA - Txagorritxu	Vitoria	Alava
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 Tip Fakultesi	Gaziantep
Turkey	Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi	Istanbul
Turkey	Dokuz Eylul University Faculty of Medicine; Chest Diseases	Izmir
Turkey	Ege Universitesi Tip Fakultesi Hastanesi	Izmir
Turkey	Kocaeli Universitesi Tip Fakultesi	Kocaeli
Turkey	Marmara Universitesi Hastanesi Marmara University Hospital	Maltepe
Turkey	Eriyes universitesi T?p Fakultesi Hastanesi	Melikgazi/Kayser
Turkey	Mersin Universitesi Tip Fakultesi Hastanesi; Tibbi Onkoloji Birimi	Mersin
Turkey	Akdeniz University Faculty of Medicine Department of Pulmonology	Muratpasa/Antalya
Turkey	Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)	Sariyer
United States	University of Alabama at Birmingham	Birmingham	Alabama
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	The Lung Research Center	Chesterfield	Missouri
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Advanced Pulmonary & Sleep Research Institute of Florida	Daytona Beach	Florida
United States	National Jewish Health Medical Center	Denver	Colorado
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	Pulmonix Research	Greensboro	North Carolina
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	University of Louisville Health Sciences Center	Louisville	Kentucky
United States	Advanced Pulmonary Research Institute	Loxahatchee Groves	Florida
United States	Metroplex Pulmonology & Sleep Center	McKinney	Texas
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	University of Nebraska Medical Center	Omaha	Nebraska
United States	Jefferson University Physicians (JUP) - Jefferson Pulmonary	Philadelphia	Pennsylvania
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	Washington University	Saint Louis	Missouri
United States	University Of Utah Hosp & Clin; Investigational Pharmacy	Salt Lake City	Utah
United States	Inst. of Healthcare Assessment, Inc.	San Diego	California
United States	UCSF Medical Center	San Francisco	California
United States	Sarasota County Public Hospital	Sarasota	Florida
United States	Spartanburg Medical Center	Spartanburg	South Carolina
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Renstar Medical Research	Wesley Chapel	Florida
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Florida Pulmonary Research Institute, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Events (AE)	Severity will be determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]).	From baseline until 8 weeks after the final dose
Primary	Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest		From baseline until 8 weeks after the final dose
Primary	Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs		From baseline until 8 weeks after the final dose
Primary	Change from Baseline in Targeted Clinical Laboratory Test Results		From baseline until 8 weeks after the final dose
Secondary	Annual Rate of Change in Forced Vital Capacity (FVC) (mL)		From baseline until study completion (up tp 4 years)
Secondary	Annual Rate of Change in 6-Minute Walk Distance (6MWD)		From baseline until study completion (up tp 4 years)
Secondary	Annual Rate of Change in FVC% Predicted		From baseline until study completion (up tp 4 years)
Secondary	Annual Rate of Change in Carbon Monoxide Diffusing Capacity (DLCO)		From baseline until study completion (up tp 4 years)
Secondary	Time to Disease Progression	Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death	From the time of randomization until disease progression or death (up tp 4 years)
Secondary	Survival		Every 6 Months and at study completion (up to 4 years)
Secondary	IPF-related Mortality		Every 6 Months and at study completion (up to 4 years)
Secondary	Respiratory-related Mortality		Every 6 Months and at study completion (up to 4 years)
Secondary	Plasma Concentrations of PRM-151 at Specified Timepoints		Days 1, 3 and 5, Weeks 4, 12 and 24
Secondary	Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline		Baseline (Day 1)
Secondary	Percentage of Participants with ADAs During the Study		Weeks 4, 12 and 24