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

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ClinicalTrials.gov Identifier: NCT04552899
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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
Idiopathic Pulmonary Fibrosis Drug: PRM-151 (Zinpentraxin Alfa) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 19, 2021
Estimated Primary Completion Date : December 29, 2023
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Absolute Change in Forced Vital Capacity (FVC [mL]) [ Time Frame: From Baseline up to Week 52 ]

Secondary Outcome Measures :
  1. Absolute Change in 6-minute Walk Distance (6MWD) [ Time Frame: From Baseline up to Week 52 ]
  2. Absolute Change in FVC% Predicted [ Time Frame: From Baseline up to Week 52 ]
  3. Time to Disease Progression [ Time Frame: From Baseline up to 2.5 years ]
  4. Time to First Respiratory-related Hospitalizations [ Time Frame: From Baseline up to 2.5 years ]
  5. Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: From Baseline up to Week 52 ]
  6. Change in St. George Respiratory Questionnaire (SGRQ) Total Score [ Time Frame: From Baseline up to Week 52 ]
  7. Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) [ Time Frame: From Baseline up to 2.5 years ]
  8. Change in Carbon Monoxide Diffusing Capacity (DLCO) [ Time Frame: From Baseline up to Week 52 ]
  9. Survival [ Time Frame: From Baseline up to 2.5 years ]
    Survivial is measured by all-cause mortality

  10. Percentage of Participants with Adverse Events (AEs) [ Time Frame: From Baseline up to 2.5 years ]
  11. Percentage of Participants with Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest [ Time Frame: From Baseline up to 2.5 years ]
  12. Percentage of Participants Permanently Discontinuing Study Treatment due to AEs [ Time Frame: From Baseline up to 2.5 years ]
  13. Change from Baseline in Targeted Clinical Laboratory Test Results [ Time Frame: From Baseline up to 2.5 years ]
  14. Plasma Concentrations of PRM-151 [ Time Frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 ]
  15. Prevalence of Anti-drug Antibodies (ADAs) at Baseline [ Time Frame: Day 1 ]
  16. Percentage of Participants with ADAs During the Study [ Time Frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04552899


Contacts
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Contact: Reference Study ID Number: WA42293 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04552899    
Other Study ID Numbers: WA42293
2020-000791-38 ( EudraCT Number )
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases