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

Study Overview
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Brief Summary
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This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).

Detailed Description
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This study is being conducted for the treatment of eligible participants who have taken part in Study PRM-151-202 and received the open-label study drug or completed the Phase III Study WA42293 with PRM-151. Participants who have discontinued treatment from or have completed Study WA42293 and do not want to receive PRM-151 in this study, will be invited to enroll in survival follow-up.

Official Title
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A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: PRM-151 (Zinpentraxin Alfa)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm. Exclusion Criteria: 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 eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant. Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula. Clinically significant laboratory test abnormalities (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRM-151<br>Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293. | Drug: PRM-151 (Zinpentraxin Alfa)<br>* Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks. Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo.<br>* Other names: Zinpentraxin Alfa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events (AE) | Severity will be 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]). | From baseline until 8 weeks after the final dose | 
| Percentage of Participants with Infusion Related Reactions (IRRs) and other AEs of Special Interest |  | From baseline until 8 weeks after the final dose | 
| Percentage of of Participants Permanently Discontinuing Study Treatment due to AEs |  | From baseline until 8 weeks after the final dose | 
| Change from Baseline in Targeted Clinical Laboratory Test Results |  | From baseline until 8 weeks after the final dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual Rate of Change in Forced Vital Capacity (FVC) (mL) |  | From baseline until study completion (up tp 4 years) | 
| Annual Rate of Change in 6-Minute Walk Distance (6MWD) |  | From baseline until study completion (up tp 4 years) | 
| Annual Rate of Change in FVC% Predicted |  | From baseline until study completion (up tp 4 years) | 
| Annual Rate of Change in Carbon Monoxide Diffusing Capacity (DLCO) |  | From baseline until study completion (up tp 4 years) | 
| Time to Disease Progression | Time to first occurrence of >=10% absolute decline in % predicted FVC, >=15% relative decline in 6MWD, or death | From the time of randomization until disease progression or death (up tp 4 years) | 
| Survival |  | Every 6 Months and at study completion (up to 4 years) | 
| IPF-related Mortality |  | Every 6 Months and at study completion (up to 4 years) | 
| Respiratory-related Mortality |  | Every 6 Months and at study completion (up to 4 years) | 
| Plasma Concentrations of PRM-151 at Specified Timepoints |  | Days 1, 3 and 5, Weeks 4, 12 and 24 | 
| Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline |  | Baseline (Day 1) | 
| Percentage of Participants with ADAs During the Study |  | Weeks 4, 12 and 24 |