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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04552899
Collaborator
(none)
658
Enrollment
350
Locations
2
Arms
33.3
Anticipated Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: PRM-151 (Zinpentraxin Alfa)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
658 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 19, 2021
Anticipated Primary Completion Date :
Dec 29, 2023
Anticipated Study Completion Date :
Dec 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: PRM-151

Participants will receive intravenous (IV) infusions of PRM-151 over 50-70 minutes on Days 1, 3 and 5, then followed by infusions every 4 weeks (Q4W) to Week 48.

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 Comparator: Placebo

Participants will receive IV infusions of placebo over 50-70 minutes on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

Drug: Placebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.

Outcome Measures

Primary Outcome Measures

  1. Absolute Change in Forced Vital Capacity (FVC [mL]) [From Baseline up to Week 52]

Secondary Outcome Measures

  1. Absolute Change in 6-minute Walk Distance (6MWD) [From Baseline up to Week 52]

  2. Absolute Change in FVC% Predicted [From Baseline up to Week 52]

  3. Time to Disease Progression [From Baseline up to 2.5 years]

  4. Time to First Respiratory-related Hospitalizations [From Baseline up to 2.5 years]

  5. Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) [From Baseline up to Week 52]

  6. Change in St. George Respiratory Questionnaire (SGRQ) Total Score [From Baseline up to Week 52]

  7. Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) [From Baseline up to 2.5 years]

  8. Change in Carbon Monoxide Diffusing Capacity (DLCO) [From Baseline up to Week 52]

  9. Survival [From Baseline up to 2.5 years]

    Survivial is measured by all-cause mortality

  10. Percentage of Participants with Adverse Events (AEs) [From Baseline up to 2.5 years]

  11. Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest [From Baseline up to 2.5 years]

  12. Percentage of Participants Permanently Discontinuing Study Treatment due to AEs [From Baseline up to 2.5 years]

  13. Change from Baseline in Targeted Clinical Laboratory Test Results [From Baseline up to 2.5 years]

  14. Plasma Concentrations of PRM-151 [Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56]

  15. Prevalence of Anti-drug Antibodies (ADAs) at Baseline [Day 1]

  16. Percentage of Participants with ADAs During the Study [Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Banner University Medical Center Phoenix; Main Pharmacy Phoenix Arizona United States 85006
3 Lovelace Scientific Resources, Inc. Phoenix Arizona United States 85016
4 UC Irvine Medical Center Orange California United States 92868
5 University of California Davis Sacramento California United States 95817
6 Inst. of Healthcare Assessment, Inc. San Diego California United States 92120
7 Sutter Health San Francisco California United States 94109
8 UCSF Medical Center San Francisco California United States 94143-0748
9 Paloma Medical Group San Juan Capistrano California United States 92675
10 William Sansum Diabetes Center Santa Barbara California United States 93105
11 Standford Hosp Stanford California United States 94305
12 University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) Aurora Colorado United States 80045
13 National Jewish Health Medical Center Denver Colorado United States 80045-2541
14 Yale New Haven Hospital New Haven Connecticut United States 06510
15 Georgetown University Medical Center Washington District of Columbia United States 20007
16 Meris Clinical Research Brandon Florida United States 33511-5719
17 Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration Celebration Florida United States 34747-1818
18 Advanced Pulmonary & Sleep Research Institute of Florida Daytona Beach Florida United States 32117
19 Malcom Randall VA Medical Center Gainesville Florida United States 32608
20 University of Florida Health Pulmonology - Jacksonville Jacksonville Florida United States 32209
21 Advanced Pulmonary Research Institute Loxahatchee Groves Florida United States 33470-9216
22 San Marcus Research Clinic Inc. Miami Florida United States 33014
23 Renstar Medical Research Ocala Florida United States 34470
24 Central Florida Pulmonary Group, PA Orlando Florida United States 32803
25 Sarasota Memorial Health Care System; Cancer Research Program Sarasota Florida United States 34239
26 Bassetti Medical Research, Inc Sebring Florida United States 33870-1216
27 University of South Florida Tampa Florida United States 33612
28 Clinical Site Partners Orlando Winter Park Florida United States 32789
29 Emory University Atlanta Georgia United States 30322
30 Piedmont Healthcare Pulmonary and Critical Care Research Austell Georgia United States 30106
31 NorthShore University HealthSystem Evanston Illinois United States 60201
32 Indiana Univ School of Med Indianapolis Indiana United States 46202
33 University of Iowa Hospitals and Clinics; Investigational Drug Services Iowa City Iowa United States 52242
34 University of Kansas Medical Center Kansas City Kansas United States 66160
35 University of Louisville Health Sciences Center Louisville Kentucky United States 40202
36 Covenant Medical Center - Cooper Saginaw Michigan United States 48602-5383
37 University of Minnesota Medical Center Minneapolis Minnesota United States 29425-8911
38 Mayo Clinic Rochester Rochester Minnesota United States 55902
39 The Lung Research Center Chesterfield Missouri United States 63017-3625
40 Washington University Saint Louis Missouri United States 63128
41 University of Nebraska Medical Center Omaha Nebraska United States 68198-0600
42 Pulmonary & Allergy Associates Summit New Jersey United States 07901-4055
43 Albany Med College Albany New York United States 12208
44 Lenox Hill Hospital New York New York United States 10075
45 American Health Research Inc. Charlotte North Carolina United States 28277
46 Duke University Medical Center Durham North Carolina United States 27710
47 Pulmonix Research Greensboro North Carolina United States 27403-1127
48 PMG Research of Wilmington Wilmington North Carolina United States 28401
49 University of Cincinnati; Department of Psychiatry and Behavioral Neuroscience Cincinnati Ohio United States 45219
50 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
51 The Ohio State University Wexner Medical Center Columbus Ohio United States 43212
52 Mercy St. Vincent Medical Center Toledo Ohio United States 43608
53 Oregon Health and Science University Portland Oregon United States 97239
54 Jefferson University Physicians (JUP) - Jefferson Pulmonary Philadelphia Pennsylvania United States 19107
55 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
56 Medical University of South Carolina Hospital Charleston South Carolina United States 29425
57 SleepMed of South Carolina Columbia South Carolina United States 29201-2953
58 Lowcountry Lung and Critical Care North Charleston South Carolina United States 29406
59 Spartanburg Medical Center Spartanburg South Carolina United States 29303
60 Vanderbilt University Medical Center Nashville Tennessee United States 37212
61 Horizon Clinical Research Group Cypress Texas United States 77429
62 Cardiopulmonary Research Science and Technology Institute Dallas Texas United States 75230
63 University of Texas Southwestern Medical Center; Heart and Lung Clinic Dallas Texas United States 75390-8575
64 DCOL Center for Clinical Research Longview Texas United States 75605-2410
65 Metroplex Pulmonology & Sleep Center McKinney Texas United States 75069
66 Audie L. Murphy VA Hospital, STVHCS San Antonio Texas United States 78229
67 University Of Utah Hosp & Clin; Investigational Pharmacy Salt Lake City Utah United States 84132
68 Inova Fairfax Hospital/IHVI; Cardiology Falls Church Virginia United States 22042
69 Virginia Commonwealth University Richmond Virginia United States 23219-1901
70 University of Wisconsin-Madison Madison Wisconsin United States 53792
71 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
72 Hospital Britanico de Buenos Aires Ciudad Autonoma Buenos Aires Argentina C1284AEB
73 Centro de Alergia y Enfermedades Respiratorias Ciudad Autonoma Buenos Aires Argentina C1414AIF
74 Fundacion Respirar (Centro Medico Dra. De Salvo) Ciudad Autonoma Buenos Aires Argentina C1426ABP
75 Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility Córdoba Argentina X5003DCE
76 Centro Medico de Enfermedades Respiratorias (CEMER) Florida Argentina
77 Centro de estudios respiratorios Mar Del Plata Argentina B7600CLK
78 INSARES Mendoza, Mendoza City Argentina M5500CCG
79 Fundacion Scherbovsky Mendoza Argentina M5500AYB
80 Investigaciones en Patologias Respiratorias San Miguel de Tucuman Argentina T4000IAR
81 Royal Prince Alfred Hospital Camperdown New South Wales Australia 2050
82 Cairns Base Hospital; Cancer Care Centre Cairns Queensland Australia 4870
83 Lung Research Queensland Nundah Queensland Australia 4101
84 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
85 The Queen Elizabeth Hospital Adelaide South Australia Australia 5011
86 Austin Hospital; Cancer Clinical Trials Centre Melbourne Victoria Australia 3084
87 Monash Medical Centre; Medicine Melbourne Victoria Australia 3186
88 The Alfred Hospital Prahan Victoria Australia 3181
89 Fiona Stanley Hospital Murdoch Western Australia Australia 6150
90 St John of God Hospital Murdoch Western Australia Australia 6150
91 Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie Salzburg Austria 5020
92 ULB Hôpital Erasme Brussels Belgium 1070
93 Cliniques Universitaires Saint-Luc; Pharmacy Bruxelles Belgium 1200
94 UZ Leuven Leuven Belgium 3000
95 C. H. U. Sart-Tilman; Laboratory Liège Belgium 4000
96 CHU UCL Namur / site Godinne Yvoir Belgium B5530
97 University of Alberta Hospital Edmonton Alberta Canada T6G 1Z1
98 Synergy Respiratory Care Sherwood Park Alberta Canada T8H ON2
99 Kelowna Respiratory and Allergy Clinic Kelowna British Columbia Canada V1W 1V3
100 Eastern Health - General Hospital St. John's Newfoundland and Labrador Canada A1B 3V6
101 The Rhema Research Institute Owen Sound Ontario Canada N4K 6M9
102 Dr. Syed Anees Medicine Profession Corporation Windsor Ontario Canada N8X 1T3
103 Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital Montreal Quebec Canada H2X 1R9
104 McGill University, Montreal Chest Institute; Viral and other Infectious Montreal Quebec Canada H2X2P4
105 C.I.C. Mauricie Trois-Rivières Quebec Canada G8T 7A1
106 CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine Beijing City China 100020
107 China-Japan Friendship Hospital Beijing City China 100029
108 Peking Union Medical College Hospital; Pharmacy Beijing City China 100730
109 Beijing Friendship Hospital Affiliated of Capital University of Medical Science Beijing Shi China 100050
110 Peking University Third Hospital Beijing China 100191
111 The Second Xiangya Hospital of Central South University Changsha China 410011
112 West China Hospital, Sichuan University Chengdu China 610041
113 Southern Medical University Nanfang Hospital Guangdong Province Guangzhou City China 510515
114 The First Affiliated Hospital of Guangzhou Medical University Guangzhou China 510120
115 Anhui Provincial Hospital Hefei China 230001
116 Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Nanjing City China 210008
117 Ningbo First Hospital Ningbo City China 315010
118 Ruijin Hospital Shanghai Jiaotong University School of Medicine Shanghai City China 200025
119 Huadong Hospital Affiliated to Fudan University Shanghai China 200040
120 Shanghai Pulmonary Hospital Shanghai China 200433
121 China Medical University (CMU) First Affiliated Hospital Shenyang City China 110001
122 Shengjing Hospital of China Medical University ShenYang China 110004
123 Tianjin Medical University General Hospital Tianjin China 300052
124 Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan City China 430030
125 Wuxi People's Hospital Wuxi China 214023
126 Tangdu Hospital, The Fourth Military Medical University; Neurology Department Xi'an City China 710038
127 Qinghai Provincial People's Hospital Xining City China 810007
128 Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital Zhengzhou City China 450000
129 The First Affiliated Hospital of Zhengzhou University Zhengzhou China 450052
130 Fakultní Nemocnice Brno Brno Czechia 625 00
131 Fakultni nemocnice Olomouc Olomouc Czechia 775 20
132 Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie Plzen Czechia 305 99
133 Nemocnice Na Bulovce Prague Czechia 180 01
134 Thomayerova nemocnice; Lekarna - pavilon H Praha 4 Czechia 140 00
135 Krajská nemocnice T. Bati, a. s. Zlín Czechia 762 75
136 Aarhus Universitetshospital Skejby Aarthus N Denmark 8200
137 Gentofte Hospital Hellerup Denmark 2900
138 Odense Universitetshospital Odense C Denmark 5000
139 Turku University Hospital Turku Finland 20521
140 Hopital Avicenne Bobigny France 93000
141 Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche Brest France 29200
142 Hopital Louis Pradel Bron France 69677
143 Hospital d Instructions des Armees Percy Clamart France 92141
144 CHU Dijon Bourgogne Hôpital François Mitterand Dijon France 21000
145 CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie La Tronche France 38700
146 Centre Hospitalier Regional Universitaire de Lille Lille France
147 Servie de Pneumologie et centre de Transplantation Pulmonaire Marseille France 13354
148 CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique Montpellier France 34295
149 CHU Nice - Hôpital Pasteur 2 Nice France 06000
150 Hopital Bichat Claude Bernard; CIC Paris France 75877
151 European Hospital Georges Pompidou (HEGP) Paris France 75908
152 Hopital Haut Leveque Pessac France 33604
153 Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche Reims France 51092
154 CHU de Rennes - Hopital de Pontchaillo Rennes France 35033
155 CHU Tours - Hôpital Bretonneau; Pharmacie Tours France 37044
156 Evang. Lungenklinik Berlin Klinik für Pneumologie Berlin Germany 13125
157 Universitatsklinikum Essen; Innere Klinik Essen Germany 45122
158 IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie Frankfurt am Main Germany 60596
159 Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie Hannover Germany 30625
160 Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik Heidelberg Germany 69120
161 Lungenfachklinik Immenhausen Immenhausen Germany 34376
162 IKF Pneumologie Mainz Helix Medical Excellence Center Mainz Mainz Germany 55128
163 Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup Marburg Germany 35037
164 Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken Münnerstadt Germany 97702
165 Krankenhaus Bethanien gGmbH Solingen Germany 42699
166 Attikon University General Hospital Ahens Greece 124 64
167 Evangelismos Hospital; Department of Critical Care and Pulmonary Services Athens Greece 106 76
168 Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine Athens Greece 115 27
169 National and Kapodistrian University of Athens EKPA Medical School Athens Greece 115 27
170 University General Hospital of Heraklion Herakleion Greece 711 10
171 University Hospital of Ioannina; Pulmonology Department Ioannina Greece 455 00
172 Hospital is University General Hospital of Larissa Larissa Greece 41110
173 Athens Medical Center Marousi Greece 151 25
174 University General Hospital of Patras Patras Greece 265 00
175 "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic " Sotiria Athens Greece 115 27
176 General Hospital of Thessaloniki G. Papanikolaou Thessaloniki Greece 57010
177 Prince of Wales Hospital; Dept. of Medicine & Therapeutics Hong Kong Hong Kong
178 The University of Hong Kong; Queen Mary Hospital Hong Kong Hong Kong
179 Semmelweis University Budapest Hungary 1081
180 Debreceni Egyetem Debrecen Hungary 4032
181 Megyei Tudogyogyintezet - Pulmonologia Farkasgyepu Hungary 8582
182 Borsod-Abauj-Zemplen (BAZ) Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz Miskolc Hungary
183 Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET Szombathely Hungary 9700
184 Szent Borbala Korhaz Tatabánya Hungary 2800
185 Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum Törökbálint Hungary 2045
186 Barzilai Medical Center; Neurology Department Ashkelon Israel 7830604
187 Shamir medical center Be'er Ya'akov Israel 0070300
188 Rambam Health Care Campus Haifa Israel 3109600
189 Bnai Zion Medical Center; Internal Medicine Haifa Israel 3339419
190 Carmel Medical Center; Obstetrics and Gynecology Haifa Israel 34362
191 Edith Wolfson Medical Center Holon Israel 5822012
192 Shaare Zedek Medical Center; Nrphrology Dept. Jerusalem Israel 9103102
193 Hadassah Medical Center Jerusalem Israel 9112001
194 Meir Medical Center Kfar- Saba Israel 4428164
195 Rabin Medical Center Petach Tiqwa Israel 4941492
196 The Chaim Sheba Medical Center Ramat Gan Israel 5211401
197 Kaplan Medical Center Rehovot Israel 7610001
198 Tel Aviv Sourasky Medical Center; Department of Neurology Tel Aviv Israel 6423906
199 AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico Napoli Campania Italy 80131
200 Azienda Ospedaliera Dei Colli Napoli Campania Italy 80131
201 Azienda Ospedaliera Universitaria Federico II Napoli Campania Italy 80131
202 Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche Napoli Campania Italy 80131
203 Ospedale Morgagni Pierantoni; Patologia clinica Forlì Emilia-Romagna Italy 47100
204 A.O.U. Policlinico di Modena Modena Emilia-Romagna Italy 40124
205 Azienda Sanitaria Universitaria Integrata di Trieste Trieste Friuli-Venezia Giulia Italy 34125
206 Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio Rome Lazio Italy 00133
207 Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia Rome Lazio Italy 00168
208 "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" " Garbagnate Milanese Lombardia Italy
209 Ospedale San Giuseppe; U.O. di Pneumologia Milano Lombardia Italy 20123
210 Asst Santi Paolo E Carlo Milano Lombardia Italy 20142
211 Ospedale San Gerardo Monza Lombardia Italy 20900
212 Fondazione IRCCS Policlinico San Matteo ; Divisione di Ematologia Dipartimento di Onco-Ematologia Pavia Lombardia Italy 27100
213 Azienda Ospedaliero Universitaria Ospedali Riuniti Torrette Di Ancona Marche Italy 60126
214 A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone Orbassano (to) Piemonte Italy 10043
215 Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette Torino Piemonte Italy 10026
216 Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia Foggia Puglia Italy 71122
217 Ospedale di Ostuni - Pneumologia Ostuni Puglia Italy 72017
218 A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale Sassari Sardegna Italy 07100
219 Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Catania Sicilia Italy 95123
220 Az. Osp. Univ. P. Giaccone; UOC di Pneumologia Palermo Sicilia Italy 90127
221 Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia Palermo Sicilia Italy 90127
222 AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2 Firenze Toscana Italy 50134
223 A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche Siena Toscana Italy 53100
224 Azienda Ospedale Università Di Padova; Clinica Pneumologica Padova Veneto Italy 35128
225 University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center Treviso Veneto Italy 31100
226 Nagoya University Hospital Aichi Japan 466-8560
227 Chiba University Hospital Chiba Japan 260-8677
228 National Hospital Organization Kyushu Medical Center Fukuoka Japan 810-8563
229 Kobe City Medical Center General Hospital Hyogo Japan 650-0047
230 National Hospital Organization Himeji Medical Center Hyogo Japan 670-8520
231 Kameda Medical Center Kamogawa Japan 296-0041
232 Kanagawa Cardiovascular and Respiratory Center Kanagawa Japan 236-0051
233 Nippon Medical School Musashi Kosugi Hospital Kawasaki-Shi Japan
234 Saiseikai Kumamoto Hospital Kumamoto-Shi Japan 861-4101
235 Nagasaki University Hospital Nagasaki Japan 852-8501
236 National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research Naka-gun Japan 319-1113
237 National Hospital Organization Kinki-Chuo Chest Medical Center Sakai-shi Japan 591-8555
238 Tosei General Hospital Seto-shi Japan 489-8642
239 Tenri Hospital Tenri-Shi Japan 632-8552
240 Jichi Medical University Hospital Tochigi Japan 329-0498
241 Tokushima University Hospital Tokushima Japan 770-8503
242 Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology Tokyo Japan 113-0034
243 Center Hospital of the National Center for Global Health and Medicine Tokyo Japan 162-0052
244 Soon Chun Hyang University Hospital Bucheon Bucheon-si, Korea, Republic of 420-767
245 The Catholic University of Korea Bucheon St. Mary's Hospital Gyeonggi-do Korea, Republic of 14662
246 Gacheon University Gil Medical Center Namdong-gu Korea, Republic of 21565
247 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
248 The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology Seoul Korea, Republic of (0)7345
249 Seoul National University Hospital (SNUH) - Medical Oncology Center Seoul Korea, Republic of 03080
250 Soonchunhyang University Hospital Seoul Korea, Republic of 04401
251 Asan Medical Center Seoul Korea, Republic of 05505
252 Samsung Medical Center Seoul Korea, Republic of 06351
253 Korea University Guro Hospital Seoul Korea, Republic of 08308
254 The Catholic University of Korea Seoul St. Mary's Hospital Seoul Korea, Republic of 137-701
255 Unidad Médica para la Salud Integral UMSI San Nicolás de Los Garza Nuevo LEON Mexico 66465
256 Unidad de Investigacion CIMA SC Chihuahua Mexico 31200
257 Centro de Diagnóstico y Tratamiento de Enfermedades Respiratorias, Medica San Isidro Metepec Mexico 52140
258 Centro Respiratorio de México Mexico Mexico 14050
259 INER- Instituto Nacional de Enfermedades Respiratorias"Ismae Mexico Mexico 14080
260 CICC Morelia Morelia Mexico
261 VU Medisch Centrum Amsterdam Netherlands 1081 HV
262 LUMC Leiden Netherlands 2333 ZA
263 Sint Antonius Ziekenhuis, locatie Nieuwegein Nieuwegein Netherlands 3430 EM
264 Erasmus Medisch Centrum Rotterdam Netherlands 3000 CA
265 Auckland City Hospital Auckland New Zealand 1023
266 NZ Respiratory & Sleep Institute Auckland New Zealand 1051
267 University of Otago, Christchurch Christchurch New Zealand 8011
268 Tauranga Hospital Tauranga New Zealand 3143
269 Soerlandet Sykehus Arendal; Medisinsk Avdeling Arendal Norway 4838
270 Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk Bergen Norway
271 Akershus universitetssykehus Lørenskog Norway 1478
272 Oslo University Hospital HF, Rikshospitalet Oslo Norway 0424
273 Hospital de Chancay Chancay Peru 15131
274 Centrum Medycyny Oddechowej Mroz sp. j. Białystok Poland 15-044
275 Nasz Lekarz Osrodek Badan Klinicznych Bydgoszcz Poland 85-312
276 Jagiellonskie Centrum Innowacji Kraków Poland 30-348
277 Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii Lodz Poland 90-153
278 Centrum Badań Klinicznych Wrocław Poland 51-162
279 Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E) Braga Portugal 4710-243
280 Centro Hospitalar Algarve Faro Portugal 8000-386
281 Hospital Senhora da Oliveira - Guimarães, E.P.E Guimaraes Portugal 4835-044
282 Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente Lisboa Portugal 1769-001
283 Centro Hospitalar do Porto - Hospital de Santo António Porto Portugal 4099-001
284 Hospital de Santa Luzia Porto Portugal 4904-858
285 CHVNG/E_Unidade 1; Servico de Pneumologia Vila Nova de Gaia Portugal 4434-502
286 Chelyabinsk Regional Clinical Hospital; Hematology Chelyabinsk Russian Federation 454076
287 State Budgetary Educational Institution of Higher Professional Education Sankt Peterburg Russian Federation 197022
288 Singapore General Hospital Singapore Singapore 169608
289 Tan Tock Seng Hospital; Oncology Singapore Singapore 308433
290 University of Cape Town Lung Institute; Lung Clinical Research Cape Town South Africa 7700
291 Johese Clinical Research Centurion South Africa 1692
292 Into Research; Life Groenkloof Hospital Medical Centre Groenkloof South Africa 0181
293 Vergelegen Medi-Clinic Somerset West South Africa 7130
294 Hospital Txagorritxu Vitoria-Gasteiz Alava Spain 01009
295 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33011
296 Hospital Universitario de Bellvitge Hospitalet de Llobregat Barcelona Spain 08907
297 Parc Taulí Sabadell Hospital Universitari Sabadell Barcelona Spain 8208
298 Hospital Universitario Marques de Valdecilla Santander Cantabria Spain 39008
299 Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario Santiago de Compostela LA Coruña Spain 15706
300 Hospital Universitario del Henares Coslada Madrid Spain 28850
301 Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Madrid Spain 28220
302 Hospital Universitario Quironsalud Madrid Pozuelo de Alarcón Madrid Spain 28223
303 Universidad de Navarra - Clinica Universitaria de Navarra (CUN) Pamplona Navarra Spain 31008
304 Hospital Universitario de Canarias S. Cristobal De La Laguna Tenerife Spain 38320
305 Hospital Galdakao-Usansolo Galdakao Vizcaya Spain 48960
306 Hospital de la Santa Creu i Sant Pau; Servicio de Neumologia Barcelona Spain 08025
307 Vall d´Hebron Institute of Oncology (VHIO), Barcelona Barcelona Spain 08035
308 Hospital Clinic de Barcelona Barcelona Spain 08036
309 Hospital Germans Trias i Pujol Barcelona Spain 08916
310 Hospital Virgen de las Nieves; Servicio de Neumologia Granada Spain 18014
311 Hospital Universitario de La Princesa Madrid Spain 28006
312 Hospital Universitario La Paz Madrid Spain 280146
313 Hospital Ramón y Cajal;Servicio de Neumología Madrid Spain 28034
314 Hosp. Clinico San Carlos Madrid Spain 28040
315 Hospital Universitario Fundacion Jimenez Diaz. Madrid Spain 28040
316 Hospital Universitario 12 de Octubre Madrid Spain 28041
317 Hospital Clinico Universitario Virgen de la Victoria Malaga Spain 29010
318 Hospital Clinico Universitario de Salamanca Salamanca Spain 37007
319 Hospital Universitario Virgen del Rocio Sevilla Spain 41013
320 Hospital Clinico Universitario de Valencia Valencia Spain 46010
321 Hospital Arnau de Vilanova (Valencia) Valencia Spain 46015
322 Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain 46026
323 Skånes universitetssjukhus Malmö Malmö Sweden 214 28
324 CHUV Lausanne Médecine Oncologie ; Département d'Oncologie médicale - BH09 - Bureau 7 Lausanne Switzerland 1011
325 Buddhist Tzu Chi Dalin General Hospital; Rheumatology Chia-yi Taiwan 622
326 Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital Kaoshiung City Taiwan 807
327 China Medical University Hospital Taichung Taiwan 40447
328 National Cheng Kung University Hospital Tainan Taiwan 70457
329 National Taiwan University Hospital Taipei Taiwan 10002
330 Far Eastern Memorial Hospital; Department of Clinical Pathology Taipei Taiwan 220
331 Veterans General Hospital - Taichung Xitun Dist. Taiwan 40705
332 Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali; Onkologi Adana Turkey 01330
333 Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi Ankara Turkey 06620
334 Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi Bursa Turkey 16059
335 Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi Gaziantep Turkey
336 Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari Istanbul Turkey 34020
337 Istanbul Universitesi Onkoloji Enstitüsü Hastanesi İstanbul Turkey 34093
338 Ege Universitesi Tip Fakultesi Hastanesi Izmir / Turkey 35100
339 Dokuz Eylul University Faculty of Medicine; Chest Diseases Izmir Turkey 35340
340 Erciyes Üniversitesi Tıp Fakültesi Kayseri Turkey 38039
341 Marmara Universitesi Hastanesi Marmara University Hospital Maltepe Turkey 34854
342 Mersin Üniversitesi Tip Fakültesi Mersin Turkey 33110
343 Akdeniz University Faculty of Medicine Department of Pulmonology Muratpasa/Antalya Turkey 07059
344 Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine) Sariyer Turkey 34450
345 Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council Dnipro Katerynoslav Governorate Ukraine 49069
346 National Academy of Medical Science of Ukraine (NAMS); NRCRM Kyiv KIEV Governorate Ukraine 03115
347 CHI Kharkiv City Clinical Hospital #13 Kharkiv Ukraine 61124
348 Yanovskyy Inst of Phth. & Pulm; Clinical-functional Kyiv Ukraine 03680
349 Odessa regional clinical Hospital Odessa Ukraine 65117
350 North Manchester General Hospital Manchester United Kingdom M8 5RB

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT04552899
Other Study ID Numbers:
  • WA42293
  • 2020-000791-38
First Posted:
Sep 17, 2020
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis

Study Results

No Results Posted as of Aug 18, 2022