Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04552899




Registration number
NCT04552899
Ethics application status
Date submitted
14/09/2020
Date registered
17/09/2020
Date last updated
18/04/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
Scientific 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
Secondary ID [1] 0 0
2020-000791-38
Secondary ID [2] 0 0
WA42293
Universal Trial Number (UTN)
Trial acronym
STARSCAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRM-151 (Zinpentraxin Alfa)
Treatment: Drugs - Placebo

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

Placebo 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.


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute Change in Forced Vital Capacity (FVC [mL])
Timepoint [1] 0 0
From Baseline up to Week 52
Secondary outcome [1] 0 0
Absolute Change in 6-minute Walk Distance (6MWD)
Timepoint [1] 0 0
From Baseline up to Week 52
Secondary outcome [2] 0 0
Absolute Change in FVC% Predicted
Timepoint [2] 0 0
From Baseline up to Week 52
Secondary outcome [3] 0 0
Time to Disease Progression
Timepoint [3] 0 0
From Baseline up to 1 year
Secondary outcome [4] 0 0
Time to First Respiratory-related Hospitalizations
Timepoint [4] 0 0
From Baseline up to 1 year
Secondary outcome [5] 0 0
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
Timepoint [5] 0 0
At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary outcome [6] 0 0
Change in St. George Respiratory Questionnaire (SGRQ) Total Score
Timepoint [6] 0 0
At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary outcome [7] 0 0
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
Timepoint [7] 0 0
From Baseline up to 1 year
Secondary outcome [8] 0 0
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Timepoint [8] 0 0
At Baseline, Week 12, Week 24, Week 36 and Week 52
Secondary outcome [9] 0 0
Survival
Timepoint [9] 0 0
From Baseline up to 1 year
Secondary outcome [10] 0 0
Percentage of Participants With Adverse Events (AEs)
Timepoint [10] 0 0
From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Secondary outcome [11] 0 0
Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
Timepoint [11] 0 0
From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Secondary outcome [12] 0 0
Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs
Timepoint [12] 0 0
From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Secondary outcome [13] 0 0
Plasma Concentrations of PRM-151
Timepoint [13] 0 0
Days 1, 5 and Weeks 4, 12, and 24
Secondary outcome [14] 0 0
Prevalence of Anti-drug Antibodies (ADAs) at Baseline
Timepoint [14] 0 0
At Baseline
Secondary outcome [15] 0 0
Percentage of Participants With ADAs During the Study
Timepoint [15] 0 0
Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56

Eligibility
Key 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
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/02/2023
Sample size
Target
Accrual to date
Final
665
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Cairns Base Hospital; Cancer Care Centre - Cairns
Recruitment hospital [3] 0 0
Lung Research Queensland - Nundah
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [6] 0 0
Austin Hospital; Cancer Clinical Trials Centre - Melbourne
Recruitment hospital [7] 0 0
Monash Medical Centre; Medicine - Melbourne
Recruitment hospital [8] 0 0
The Alfred Hospital - Prahan
Recruitment hospital [9] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment postcode(s) [3] 0 0
4101 - Nundah
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
5011 - Adelaide
Recruitment postcode(s) [6] 0 0
3084 - Melbourne
Recruitment postcode(s) [7] 0 0
3186 - Melbourne
Recruitment postcode(s) [8] 0 0
3181 - Prahan
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Wisconsin
Country [31] 0 0
Argentina
State/province [31] 0 0
Ciudad Autonoma Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Córdoba
Country [33] 0 0
Argentina
State/province [33] 0 0
Florida, Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Mar Del Plata
Country [35] 0 0
Argentina
State/province [35] 0 0
Mendoza, Mendoza City
Country [36] 0 0
Argentina
State/province [36] 0 0
Mendoza
Country [37] 0 0
Argentina
State/province [37] 0 0
San Miguel de Tucuman
Country [38] 0 0
Austria
State/province [38] 0 0
Klagenfurt
Country [39] 0 0
Austria
State/province [39] 0 0
Salzburg
Country [40] 0 0
Belgium
State/province [40] 0 0
Brussels
Country [41] 0 0
Belgium
State/province [41] 0 0
Bruxelles
Country [42] 0 0
Belgium
State/province [42] 0 0
Leuven
Country [43] 0 0
Belgium
State/province [43] 0 0
Liège
Country [44] 0 0
Belgium
State/province [44] 0 0
Yvoir
Country [45] 0 0
Brazil
State/province [45] 0 0
MG
Country [46] 0 0
Brazil
State/province [46] 0 0
RS
Country [47] 0 0
Canada
State/province [47] 0 0
Alberta
Country [48] 0 0
Canada
State/province [48] 0 0
British Columbia
Country [49] 0 0
Canada
State/province [49] 0 0
Newfoundland and Labrador
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
China
State/province [52] 0 0
Beijing City
Country [53] 0 0
China
State/province [53] 0 0
Beijing Shi
Country [54] 0 0
China
State/province [54] 0 0
Beijing
Country [55] 0 0
China
State/province [55] 0 0
Changsha City
Country [56] 0 0
China
State/province [56] 0 0
Changsha
Country [57] 0 0
China
State/province [57] 0 0
Chengdu
Country [58] 0 0
China
State/province [58] 0 0
Guangdong Province Guangzhou City
Country [59] 0 0
China
State/province [59] 0 0
Guangzhou City
Country [60] 0 0
China
State/province [60] 0 0
Guangzhou
Country [61] 0 0
China
State/province [61] 0 0
Hangzhou City
Country [62] 0 0
China
State/province [62] 0 0
Hohhot City
Country [63] 0 0
China
State/province [63] 0 0
Jinan
Country [64] 0 0
China
State/province [64] 0 0
Nanchang City
Country [65] 0 0
China
State/province [65] 0 0
Nanjing City
Country [66] 0 0
China
State/province [66] 0 0
Ningbo City
Country [67] 0 0
China
State/province [67] 0 0
Shanghai City
Country [68] 0 0
China
State/province [68] 0 0
Shanghai
Country [69] 0 0
China
State/province [69] 0 0
Shenyang City
Country [70] 0 0
China
State/province [70] 0 0
ShenYang
Country [71] 0 0
China
State/province [71] 0 0
Shijiazhuang City
Country [72] 0 0
China
State/province [72] 0 0
Tianjin
Country [73] 0 0
China
State/province [73] 0 0
Wuhan City
Country [74] 0 0
China
State/province [74] 0 0
Wuxi
Country [75] 0 0
China
State/province [75] 0 0
Xi'an City
Country [76] 0 0
China
State/province [76] 0 0
Xining City
Country [77] 0 0
China
State/province [77] 0 0
Zhengzhou City
Country [78] 0 0
China
State/province [78] 0 0
Zhengzhou
Country [79] 0 0
Czechia
State/province [79] 0 0
Brno
Country [80] 0 0
Czechia
State/province [80] 0 0
Olomouc
Country [81] 0 0
Czechia
State/province [81] 0 0
Plzen
Country [82] 0 0
Czechia
State/province [82] 0 0
Prague
Country [83] 0 0
Czechia
State/province [83] 0 0
Praha 4
Country [84] 0 0
Czechia
State/province [84] 0 0
Zlín
Country [85] 0 0
Denmark
State/province [85] 0 0
Aarthus N
Country [86] 0 0
Denmark
State/province [86] 0 0
Hellerup
Country [87] 0 0
Denmark
State/province [87] 0 0
Odense C
Country [88] 0 0
Finland
State/province [88] 0 0
Turku
Country [89] 0 0
France
State/province [89] 0 0
Bobigny
Country [90] 0 0
France
State/province [90] 0 0
Brest
Country [91] 0 0
France
State/province [91] 0 0
Bron
Country [92] 0 0
France
State/province [92] 0 0
Clamart
Country [93] 0 0
France
State/province [93] 0 0
Dijon
Country [94] 0 0
France
State/province [94] 0 0
La Tronche
Country [95] 0 0
France
State/province [95] 0 0
Lille
Country [96] 0 0
France
State/province [96] 0 0
Marseille
Country [97] 0 0
France
State/province [97] 0 0
Montpellier
Country [98] 0 0
France
State/province [98] 0 0
Nice
Country [99] 0 0
France
State/province [99] 0 0
Paris
Country [100] 0 0
France
State/province [100] 0 0
Pessac
Country [101] 0 0
France
State/province [101] 0 0
Reims
Country [102] 0 0
France
State/province [102] 0 0
Rennes
Country [103] 0 0
France
State/province [103] 0 0
Tours
Country [104] 0 0
Germany
State/province [104] 0 0
Bad Berka
Country [105] 0 0
Germany
State/province [105] 0 0
Berlin
Country [106] 0 0
Germany
State/province [106] 0 0
Essen
Country [107] 0 0
Germany
State/province [107] 0 0
Frankfurt am Main
Country [108] 0 0
Germany
State/province [108] 0 0
Gießen
Country [109] 0 0
Germany
State/province [109] 0 0
Hannover
Country [110] 0 0
Germany
State/province [110] 0 0
Heidelberg
Country [111] 0 0
Germany
State/province [111] 0 0
Homburg/Saar
Country [112] 0 0
Germany
State/province [112] 0 0
Immenhausen
Country [113] 0 0
Germany
State/province [113] 0 0
Leipzig
Country [114] 0 0
Germany
State/province [114] 0 0
Mainz
Country [115] 0 0
Germany
State/province [115] 0 0
Marburg
Country [116] 0 0
Germany
State/province [116] 0 0
Münnerstadt
Country [117] 0 0
Germany
State/province [117] 0 0
Solingen
Country [118] 0 0
Greece
State/province [118] 0 0
Athens
Country [119] 0 0
Greece
State/province [119] 0 0
Chaidari
Country [120] 0 0
Greece
State/province [120] 0 0
Heraklio
Country [121] 0 0
Greece
State/province [121] 0 0
Ioannina
Country [122] 0 0
Greece
State/province [122] 0 0
Larissa
Country [123] 0 0
Greece
State/province [123] 0 0
Marousi
Country [124] 0 0
Greece
State/province [124] 0 0
Patras
Country [125] 0 0
Greece
State/province [125] 0 0
Sotiria Athens
Country [126] 0 0
Greece
State/province [126] 0 0
Thessaloniki
Country [127] 0 0
Hong Kong
State/province [127] 0 0
Hong Kong
Country [128] 0 0
Hungary
State/province [128] 0 0
Budapest
Country [129] 0 0
Hungary
State/province [129] 0 0
Debrecen
Country [130] 0 0
Hungary
State/province [130] 0 0
Szombathely
Country [131] 0 0
Hungary
State/province [131] 0 0
Tatabánya
Country [132] 0 0
Hungary
State/province [132] 0 0
Törökbálint
Country [133] 0 0
Israel
State/province [133] 0 0
Ashkelon
Country [134] 0 0
Israel
State/province [134] 0 0
Be'er Ya'akov
Country [135] 0 0
Israel
State/province [135] 0 0
Beer sheva
Country [136] 0 0
Israel
State/province [136] 0 0
Haifa
Country [137] 0 0
Israel
State/province [137] 0 0
Holon
Country [138] 0 0
Israel
State/province [138] 0 0
Jerusalem
Country [139] 0 0
Israel
State/province [139] 0 0
Kfar- Saba
Country [140] 0 0
Israel
State/province [140] 0 0
Petach Tiqwa
Country [141] 0 0
Israel
State/province [141] 0 0
Ramat Gan
Country [142] 0 0
Israel
State/province [142] 0 0
Rehovot
Country [143] 0 0
Israel
State/province [143] 0 0
Tel Aviv
Country [144] 0 0
Italy
State/province [144] 0 0
Abruzzo
Country [145] 0 0
Italy
State/province [145] 0 0
Campania
Country [146] 0 0
Italy
State/province [146] 0 0
Emilia-Romagna
Country [147] 0 0
Italy
State/province [147] 0 0
Friuli-Venezia Giulia
Country [148] 0 0
Italy
State/province [148] 0 0
Lazio
Country [149] 0 0
Italy
State/province [149] 0 0
Lombardia
Country [150] 0 0
Italy
State/province [150] 0 0
Marche
Country [151] 0 0
Italy
State/province [151] 0 0
Piemonte
Country [152] 0 0
Italy
State/province [152] 0 0
Puglia
Country [153] 0 0
Italy
State/province [153] 0 0
Sardegna
Country [154] 0 0
Italy
State/province [154] 0 0
Sicilia
Country [155] 0 0
Italy
State/province [155] 0 0
Toscana
Country [156] 0 0
Italy
State/province [156] 0 0
Veneto
Country [157] 0 0
Japan
State/province [157] 0 0
Aichi
Country [158] 0 0
Japan
State/province [158] 0 0
Chiba
Country [159] 0 0
Japan
State/province [159] 0 0
Fukuoka
Country [160] 0 0
Japan
State/province [160] 0 0
Hyogo
Country [161] 0 0
Japan
State/province [161] 0 0
Kamogawa
Country [162] 0 0
Japan
State/province [162] 0 0
Kanagawa
Country [163] 0 0
Japan
State/province [163] 0 0
Kawasaki-Shi
Country [164] 0 0
Japan
State/province [164] 0 0
Kumamoto-Shi
Country [165] 0 0
Japan
State/province [165] 0 0
Nagasaki
Country [166] 0 0
Japan
State/province [166] 0 0
Naka-gun
Country [167] 0 0
Japan
State/province [167] 0 0
Okayama
Country [168] 0 0
Japan
State/province [168] 0 0
Sakai-shi
Country [169] 0 0
Japan
State/province [169] 0 0
Seto-shi
Country [170] 0 0
Japan
State/province [170] 0 0
Tenri-Shi
Country [171] 0 0
Japan
State/province [171] 0 0
Tochigi
Country [172] 0 0
Japan
State/province [172] 0 0
Tokushima
Country [173] 0 0
Japan
State/province [173] 0 0
Tokyo
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Bucheon-si,
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Gyeonggi-do
Country [176] 0 0
Korea, Republic of
State/province [176] 0 0
Namdong-gu
Country [177] 0 0
Korea, Republic of
State/province [177] 0 0
Seongnam-si
Country [178] 0 0
Korea, Republic of
State/province [178] 0 0
Seoul
Country [179] 0 0
Mexico
State/province [179] 0 0
Mexico CITY (federal District)
Country [180] 0 0
Mexico
State/province [180] 0 0
Nuevo LEON
Country [181] 0 0
Mexico
State/province [181] 0 0
Chihuahua
Country [182] 0 0
Mexico
State/province [182] 0 0
Morelia
Country [183] 0 0
Netherlands
State/province [183] 0 0
Amsterdam
Country [184] 0 0
Netherlands
State/province [184] 0 0
Nieuwegein
Country [185] 0 0
Netherlands
State/province [185] 0 0
Rotterdam
Country [186] 0 0
New Zealand
State/province [186] 0 0
Auckland
Country [187] 0 0
New Zealand
State/province [187] 0 0
Christchurch
Country [188] 0 0
New Zealand
State/province [188] 0 0
Hamilton
Country [189] 0 0
New Zealand
State/province [189] 0 0
Tauranga
Country [190] 0 0
Norway
State/province [190] 0 0
Bergen
Country [191] 0 0
Norway
State/province [191] 0 0
Lørenskog
Country [192] 0 0
Norway
State/province [192] 0 0
Oslo
Country [193] 0 0
Poland
State/province [193] 0 0
Bia?ystok
Country [194] 0 0
Poland
State/province [194] 0 0
Bydgoszcz
Country [195] 0 0
Poland
State/province [195] 0 0
Lodz
Country [196] 0 0
Portugal
State/province [196] 0 0
Braga
Country [197] 0 0
Portugal
State/province [197] 0 0
Faro
Country [198] 0 0
Portugal
State/province [198] 0 0
Guimaraes
Country [199] 0 0
Portugal
State/province [199] 0 0
Lisboa
Country [200] 0 0
Portugal
State/province [200] 0 0
Porto
Country [201] 0 0
Portugal
State/province [201] 0 0
Vila Nova de Gaia
Country [202] 0 0
Singapore
State/province [202] 0 0
Singapore
Country [203] 0 0
South Africa
State/province [203] 0 0
Cape Town
Country [204] 0 0
South Africa
State/province [204] 0 0
Somerset West
Country [205] 0 0
Spain
State/province [205] 0 0
Alava
Country [206] 0 0
Spain
State/province [206] 0 0
Asturias
Country [207] 0 0
Spain
State/province [207] 0 0
Barcelona
Country [208] 0 0
Spain
State/province [208] 0 0
Cantabria
Country [209] 0 0
Spain
State/province [209] 0 0
LA Coruña
Country [210] 0 0
Spain
State/province [210] 0 0
Madrid
Country [211] 0 0
Spain
State/province [211] 0 0
Navarra
Country [212] 0 0
Spain
State/province [212] 0 0
Tenerife
Country [213] 0 0
Spain
State/province [213] 0 0
Vizcaya
Country [214] 0 0
Spain
State/province [214] 0 0
Granada
Country [215] 0 0
Spain
State/province [215] 0 0
Malaga
Country [216] 0 0
Spain
State/province [216] 0 0
Salamanca
Country [217] 0 0
Spain
State/province [217] 0 0
Sevilla
Country [218] 0 0
Spain
State/province [218] 0 0
Valencia
Country [219] 0 0
Sweden
State/province [219] 0 0
Malmö
Country [220] 0 0
Switzerland
State/province [220] 0 0
Bern
Country [221] 0 0
Switzerland
State/province [221] 0 0
Neuchâtel
Country [222] 0 0
Taiwan
State/province [222] 0 0
Chia-yi
Country [223] 0 0
Taiwan
State/province [223] 0 0
Kaoshiung City
Country [224] 0 0
Taiwan
State/province [224] 0 0
Taichung
Country [225] 0 0
Taiwan
State/province [225] 0 0
Tainan
Country [226] 0 0
Taiwan
State/province [226] 0 0
Taipei
Country [227] 0 0
Taiwan
State/province [227] 0 0
Xitun Dist.
Country [228] 0 0
Turkey
State/province [228] 0 0
?stanbul
Country [229] 0 0
Turkey
State/province [229] 0 0
Adana
Country [230] 0 0
Turkey
State/province [230] 0 0
Ankara
Country [231] 0 0
Turkey
State/province [231] 0 0
Bursa
Country [232] 0 0
Turkey
State/province [232] 0 0
Gaziantep
Country [233] 0 0
Turkey
State/province [233] 0 0
Istanbul
Country [234] 0 0
Turkey
State/province [234] 0 0
Izmir
Country [235] 0 0
Turkey
State/province [235] 0 0
Kayseri
Country [236] 0 0
Turkey
State/province [236] 0 0
Kocaeli
Country [237] 0 0
Turkey
State/province [237] 0 0
Maltepe
Country [238] 0 0
Turkey
State/province [238] 0 0
Mersin
Country [239] 0 0
Turkey
State/province [239] 0 0
Muratpasa/Antalya
Country [240] 0 0
Turkey
State/province [240] 0 0
Sariyer
Country [241] 0 0
Ukraine
State/province [241] 0 0
Katerynoslav Governorate
Country [242] 0 0
Ukraine
State/province [242] 0 0
KIEV Governorate
Country [243] 0 0
Ukraine
State/province [243] 0 0
Kyiv
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Edinburgh
Country [245] 0 0
United Kingdom
State/province [245] 0 0
London
Country [246] 0 0
United Kingdom
State/province [246] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04552899
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04552899