This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
665
A 10 mg/kg IV infusion of PRM-151 based on the participants weight will be administered on Days 1, 3 and 5 followed by infusions Q4W to Week 48.
Placebo matching PRM-151 will be administered by IV infusion on Days 1, 3 and 5, followed by infusions Q4W to Week 48.
Absolute Change in Forced Vital Capacity (FVC [mL])
Time frame: From Baseline up to Week 52
Absolute Change in 6-minute Walk Distance (6MWD)
Time frame: From Baseline up to Week 52
Absolute Change in FVC% Predicted
Time frame: From Baseline up to Week 52
Time to Disease Progression
Time frame: From Baseline up to 1 year
Time to First Respiratory-related Hospitalizations
Time frame: From Baseline up to 1 year
Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ)
The UCSD-SOBQ is a 24-item questionnaire used to assess dyspnea severity during specific activities (21 items) and limitations caused by dyspnea in daily life (4 items). Items are assessed using a 6-point scale. Total scores, once summed, can range from 0-120 with a higher score reflecting greater dyspnea severity.
Time frame: At Baseline, Week 12, Week 24, Week 36 and Week 52
Change in St. George Respiratory Questionnaire (SGRQ) Total Score
The SGRQ is a 50-item respiratory-specific quality-of-life questionnaire. The questions assess the impact of disease on activity, functionality and symptoms. Each scale is scored from 0-100. A total score represents the weighted average of these three subscores. A lower score indicates best health while a higher score indicates worst health.
Time frame: At Baseline, Week 12, Week 24, Week 36 and Week 52
Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University Medical Center Phoenix; Main Pharmacy
Phoenix, Arizona, United States
Lovelace Scientific Resources, Inc.
Phoenix, Arizona, United States
UC Irvine Medical Center
Orange, California, United States
Stanford Hospital and Clinics
Palo Alto, California, 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
Paloma Medical Group
San Juan Capistrano, California, United States
William Sansum Diabetes Center
Santa Barbara, California, United States
...and 350 more locations
Time frame: From Baseline up to 1 year
Change in Carbon Monoxide Diffusing Capacity (DLCO)
Time frame: At Baseline, Week 12, Week 24, Week 36 and Week 52
Survival
Survival is measured by all-cause mortality
Time frame: From Baseline up to 1 year
Percentage of Participants With Adverse Events (AEs)
Time frame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest
Time frame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs
Time frame: From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year)
Plasma Concentrations of PRM-151
Time frame: Days 1, 5 and Weeks 4, 12, and 24
Prevalence of Anti-drug Antibodies (ADAs) at Baseline
Time frame: At Baseline
Percentage of Participants With ADAs During the Study
Time frame: Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56