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

Phase 3

Terminated

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: PRM-151 (Zinpentraxin Alfa)

• Registration Number: NCT04594707
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-20
• Study Start: 2021-08-30
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Results First Submitted: 2024-02-02
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Results First Posted: 2024-05-16
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zinpentraxin Alfa	PRM-151 (Zinpentraxin Alfa)	Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	From baseline until 8 weeks after the final dose, an average of 6 months	An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a pharmaceutical product, regardless of causal attribution. Grading was completed according to the CTCAE, version 5.0.
Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest	From baseline until 8 weeks after the final dose, an average of 6 months	IRRs were defined as AEs that occurred during or within 24 hours after study drug administration and were judged to be related to study drug infusion.
Percentage of of Participants Permanently Discontinuing Study Treatment Due to AEs	From baseline until 8 weeks after the final dose, an average of 6 months

Secondary Outcome Measures

Name	Time	Method
Annual Rate of Change in FVC% Predicted	From baseline until study completion (up to approximately 1.5 years)
IPF-related Mortality	Every 6 Months and at study completion (up to approximately 1.5 years)
Annual Rate of Change in 6-Minute Walk Distance (6MWD)	From baseline until study completion (up to approximately 1.5 years)
Change in Carbon Monoxide Diffusing Capacity (DLCO)	At Baseline, Week 24 and Week 48
Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline	Baseline (Day 1)	Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
Percentage of Participants With ADAs During the Study	Weeks 4, 12 and 24	Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
Time to Disease Progression	From baseline until study completion (up to approximately 1.5 years)	Time to first occurrence of \>=10% absolute decline in % predicted FVC, \>=15% relative decline in 6MWD, or death
Respiratory-related Mortality	Every 6 Months and at study completion (up to approximately 1.5 years)
Plasma Concentrations of PRM-151 at Specified Timepoints	Days 1 and 5, Weeks 4, and 12	Due to early termination of the study, only participants enrolled in Cohort A receiving at least one IV dose of zinpentraxin alfa had their plasma concentrations analyzed.
Annual Rate of Change in Forced Vital Capacity (FVC) (mL)	From baseline until study completion (up to approximately 1.5 years)
Survival	Every 6 Months and at study completion (up to approximately 1.5 years)

Trial Locations

Locations (248)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

Inst. of Healthcare Assessment, Inc.; 🇺🇸 San Diego, California, United States

UCSF Medical Center; 🇺🇸 San Francisco, California, United States

National Jewish Health Medical Center; 🇺🇸 Denver, Colorado, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Georgetown University Medical Center; 🇺🇸 Washington, District of Columbia, United States

Meris Clinical Research; 🇺🇸 Brandon, Florida, United States

Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration; 🇺🇸 Celebration, Florida, United States

Advanced Pulmonary & Sleep Research Institute of Florida; 🇺🇸 Daytona Beach, Florida, United States

Scroll for more (238 remaining)