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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

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
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Arizona
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Aarthus N
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Hellerup
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Odense C
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Israel
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Israel
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Israel
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Holon
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Israel
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Israel
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Kfar- Saba
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Israel
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Petach Tiqwa
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Italy
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Italy
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Italy
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Aichi
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Chiba
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Fukuoka
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Hyogo
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Kanagawa
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Okayama
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Gyeonggi-do
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Korea, Republic of
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04552899