A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Patients with Idiopathic Pulmonary Fibrosis

A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001429-30-HU

Enrollment

700

Registered

2020-12-09

Start date

2021-02-05

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis (IPF) MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: Recombinant human Pentraxin-2 (PRM-151) Product Code: RO7490677 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Recombinant human Pentraxin-2 Other descriptive name: PRM-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Taken part in a previous study of PRM-151, as follows: o Participated in Study PRM-151-202, and tolerated the study drug in the opinion of the investigator OR Completed study treatment in Study WA42293 OR Participated in Study WA42293 but have discontinued from study treatment • For women of childbearing potential: agreement to remain abstinent or use contraception, women must remain abstinent or use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 500

Exclusion criteria

Exclusion criteria: ? Received any experimental treatment other than PRM-151 within 4 weeks or five half-lives of the experimental drug, whichever is longer, prior to the first dose in the OLE study ? Receiving strong inhibitor or inducer of CYP1A2 in patients taking pirfenidone ? Receiving potent inhibitor or inducer of P-gp in patients taking nintedanib ? Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202) ? History of smoking within 3 months prior to the first visit in the OLE ? History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder ? History of severe allergic reaction or anaphylactic reaction to PRM-151 ? Clinically significant abnormality on ECG during screening including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula; or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient

Design outcomes

Primary

Measure	Time frame
Main Objective: To confirm long-term safety and tolerability of 10 mg/kg PRM-151 administered every 4 weeks (Q4W) via intravenous infusion plus standard of care (SOC) treatment;Secondary Objective: ? To assess the long-term efficacy of 10 mg/kg PRM-151 plus SOC administered Q4W via IV infusion ? To characterize pharmacokinetics of PRM-151 in patients with IPF ? To evaluate the immune response to PRM-151 ;Primary end point(s): 1. Incidence and severity of adverse events (AE), with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]) 2. Incidence and severity of IRRs and other AEs of special interest 3. Proportion of patients permanently discontinuing study treatment due to AEs 4. Change from baseline in targeted clinical laboratory test results ;Timepoint(s) of evaluation of this end point: 1-3. Approximately 8 weeks after the last dose of study drug 4. From baseline (Day 1) to 8 weeks after the last dose of study drug	—

Measure

Time frame

Main Objective: To confirm long-term safety and tolerability of 10 mg/kg PRM-151 administered every 4 weeks (Q4W) via intravenous infusion plus standard of care (SOC) treatment;Secondary Objective: ? To assess the long-term efficacy of 10 mg/kg PRM-151 plus SOC administered Q4W via IV infusion ? To characterize pharmacokinetics of PRM-151 in patients with IPF ? To evaluate the immune response to PRM-151 ;Primary end point(s): 1. Incidence and severity of adverse events (AE), with severity determined according to the 5-point severity scale (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 [NCI CTCAE, v.5.0]) 2. Incidence and severity of IRRs and other AEs of special interest 3. Proportion of patients permanently discontinuing study treatment due to AEs 4. Change from baseline in targeted clinical laboratory test results ;Timepoint(s) of evaluation of this end point: 1-3. Approximately 8 weeks after the last dose of study drug 4. From baseline (Day 1) to 8 weeks after the last dose of study drug

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Secondary

Measure	Time frame
Secondary end point(s): 1. Annual rate of decline in forced vital capacity (FVC) (mL) 2. Annual rate of change in 6-minute walk distance 3. Annual rate of decline in FVC% predicted 4. Progression-free survival 5. Change from baseline in University of California, San Diego-Shortness of Breath Questionnaire 6. Change from baseline in St. George Respiratory Questionnaire Total Score 7. Change from baseline in carbon monoxide diffusing capacity 8. Survival 9. Plasma concentrations of PRM-151 at specified timepoints for a subset of patients 10. Prevalence of anti-drug antibodies (ADAs) to PRM-151 at baseline and incidence of ADAs during the study ;Timepoint(s) of evaluation of this end point: 1. End of study 2. End of study. 3. End of study 4. Time to first occurrence of >= 10% absolute decline in % predicted FVC, >= 15% relative decline in 6MWD, or death 5-7. Day 1, Week 24 and then every 24 weeks thereafter and at treatment discontinuation 8. Every 6 months and at study completion or discontinuation 9. Day 1, 3, 5. Week 4, 12, 24 and at unscheduled visit 10. Baseline (Day 1), Week 4, 12, 24 and at unscheduled visit	—

Measure

Time frame

Secondary end point(s): 1. Annual rate of decline in forced vital capacity (FVC) (mL) 2. Annual rate of change in 6-minute walk distance 3. Annual rate of decline in FVC% predicted 4. Progression-free survival 5. Change from baseline in University of California, San Diego-Shortness of Breath Questionnaire 6. Change from baseline in St. George Respiratory Questionnaire Total Score 7. Change from baseline in carbon monoxide diffusing capacity 8. Survival 9. Plasma concentrations of PRM-151 at specified timepoints for a subset of patients 10. Prevalence of anti-drug antibodies (ADAs) to PRM-151 at baseline and incidence of ADAs during the study ;Timepoint(s) of evaluation of this end point: 1. End of study 2. End of study. 3. End of study 4. Time to first occurrence of >= 10% absolute decline in % predicted FVC, >= 15% relative decline in 6MWD, or death 5-7. Day 1, Week 24 and then every 24 weeks thereafter and at treatment discontinuation 8. Every 6 months and at study completion or discontinuation 9. Day 1, 3, 5. Week 4, 12, 24 and at unscheduled visit 10. Baseline (Day 1), Week 4, 12, 24 and at unscheduled visit

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Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactTrial Information Support Line-TISL

F. Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026