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).
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
117
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.
Percentage of Participants With Adverse Events (AEs)
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.
Time frame: From baseline until 8 weeks after the final dose, an average of 6 months
Percentage of Participants With Infusion Related Reactions (IRRs) and Other AEs of Special Interest
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.
Time frame: From baseline until 8 weeks after the final dose, an average of 6 months
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
Annual Rate of Change in Forced Vital Capacity (FVC) (mL)
Time frame: From baseline until study completion (up to approximately 1.5 years)
Annual Rate of Change in 6-Minute Walk Distance (6MWD)
Time frame: From baseline until study completion (up to approximately 1.5 years)
Annual Rate of Change in FVC% Predicted
Time frame: From baseline until study completion (up to approximately 1.5 years)
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Time frame: At Baseline, Week 24 and Week 48
Time to Disease Progression
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 D.C., 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
...and 238 more locations
Time to first occurrence of \>=10% absolute decline in % predicted FVC, \>=15% relative decline in 6MWD, or death
Time frame: From baseline until study completion (up to approximately 1.5 years)
Survival
Time frame: Every 6 Months and at study completion (up to approximately 1.5 years)
IPF-related Mortality
Time frame: Every 6 Months and at study completion (up to approximately 1.5 years)
Respiratory-related Mortality
Time frame: Every 6 Months and at study completion (up to approximately 1.5 years)
Plasma Concentrations of PRM-151 at Specified Timepoints
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.
Time frame: Days 1 and 5, Weeks 4, and 12
Prevalence of Anti-drug Antibodies (ADAs) to PRM-151 at Baseline
Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
Time frame: Baseline (Day 1)
Percentage of Participants With ADAs During the Study
Due to early termination of the study, only ADA samples from participants in Cohort A were analyzed.
Time frame: Weeks 4, 12 and 24