A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis

Hoffmann-La Roche360 sites in 1 country665 target enrollmentMarch 19, 2021

ConditionsIdiopathic Pulmonary Fibrosis

InterventionsPRM-151 (Zinpentraxin Alfa)Placebo

DrugsPRM-151 (Zinpentraxin Alfa)Placebo

Overview

Phase: Phase 3
Intervention: PRM-151 (Zinpentraxin Alfa)
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Hoffmann-La Roche
Enrollment: 665
Locations: 360
Primary Endpoint: Absolute Change in Forced Vital Capacity (FVC [mL])
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 19, 2021

End Date

February 10, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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.

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

Arms & Interventions

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.

Intervention: PRM-151 (Zinpentraxin Alfa)

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.

Intervention: Placebo

Outcomes

Primary Outcomes

Absolute Change in Forced Vital Capacity (FVC [mL])

Time Frame: From Baseline up to Week 52

Secondary Outcomes

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