A Phase III Open-label Extension Study to Evaluate Long-term Safety and Efficacy of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Overview
- Phase
- Phase 3
- Intervention
- PRM-151 (Zinpentraxin Alfa)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 117
- Locations
- 248
- Primary Endpoint
- Percentage of Participants With Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA
- •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-
- •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.
Arms & Interventions
Zinpentraxin Alfa
Corhort A: Participants entering, following participation in study PRM-151-202. Cohort B: Participants entering, following participation in study WA42293.
Intervention: PRM-151 (Zinpentraxin Alfa)
Outcomes
Primary Outcomes
Percentage of Participants With Adverse Events (AEs)
Time Frame: 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
Time Frame: 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
Time Frame: From baseline until 8 weeks after the final dose, an average of 6 months
Secondary Outcomes
- 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))
- Percentage of Participants With ADAs During the Study(Weeks 4, 12 and 24)
- Time to Disease Progression(From baseline until study completion (up to approximately 1.5 years))
- 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)
- 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))