This study is a Phase 2, randomized, double-blind, placebo controlled, pilot study designed to evaluate the efficacy and safety of PRM-151 administered through Week 24 to subjects with IPF.
PRM-151 is an anti-fibrotic immunomodulator being developed for treatment of fibrotic diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
117
UCSF Interstitial Lung Disease Program
San Francisco, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]
Determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling subjects on a stable dose of pirfenidone or nintedanib with subjects not on other treatment for IPF.
Time frame: 0 to 28 weeks
Change From Baseline in 6-Minute Walk Distance (6MWD)
Time frame: 0 to 28 weeks
Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)
Mean change from baseline in total lung volume on HRCT using quantitative imaging software.
Time frame: 0 to 28 weeks
Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT
Mean change from baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software
Time frame: 0 to 28 weeks
Change From Baseline in % of Total Lung Volume of ILA on HRCT
Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing, using quantitative imaging software
Time frame: 0 to 28 weeks
Change From Baseline in Volume of Normal Lung on HRCT
Mean change from baseline in volume of parenchymal features on HRCT representative of normal lung (non-ILA), including normal and mild low attenuation areas, using quantitative imaging software.
Time frame: 0 to 28 weeks
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Yale University School of Medicine
New Haven, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UT - Southwestern Medical School
Dallas, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
...and 8 more locations
Change From Baseline in % of Normal Lung on HRCT (%)
Mean change from baseline in % of total lung volume of parenchymal features on HRCT representative of normal lung (non-ILA), including normal and mild low attenuation areas, using quantitative imaging software.
Time frame: 0 to 28 weeks
Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA
Correlation between mean change from Baseline in FVC \[% predicted\] and mean change from Baseline in volume of parenchymal features on HRCT representative of ILA, including ground glass density, reticular changes, and honeycombing by quantitative imaging software.
Time frame: 0 to 28 weeks
Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28.
Pulmonary Function Tests for the Proportion (%) of subjects with a decline in FVC% predicted of ≥ 5% and ≥ 10% from Baseline to Week 28.
Time frame: 0 to 28 weeks
Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28.
Time frame: 0 to 28 weeks
Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28.
Time frame: 0 to 28 weeks
Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28
Time frame: 0 to 28 weeks
Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28.
Time frame: 0 to 28 weeks
Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28.
Time frame: 0 to 28 weeks
Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).
Pulmonary Function Tests to discern the mean change from Baseline to Week 28 in % predicted diffusion capacity of carbon monoxide (DLCO).
Time frame: 0 to 28 weeks
Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Tolerability/safety was assessed over the 28-week study period by the number of reported TEAEs
Time frame: 0 to 28 weeks
Percentage of Subjects Discontinuing Study Drug Due to AEs
Tolerability/safety was assessed over the 28-week study period by the proportion of subjects who discontinued study drug due to AEs
Time frame: 0 to 28 weeks
Percentage of Subjects Reporting Serious Adverse Events (SAEs)
Tolerability/safety was assessed over the 28-week study period by incidence of SAEs
Time frame: 0 to 28 weeks
Percentage of Subjects Reporting Respiratory Decline AEs
Tolerability/safety was assessed over the 28-week study period by the number of reported respiratory decline AEs, defined as follows: * Unscheduled visits to a healthcare professional for respiratory status deterioration. * Urgent care visits for respiratory status deterioration. * Hospitalization due to a worsening or exacerbation of respiratory symptoms.
Time frame: 0 to 28 weeks
Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability]
Tolerability/safety was assessed over the 28-week study period by the number of reported serious respiratory decline AEs
Time frame: 0 to 28 weeks
Percentage of Subjects With Infusion Related Reactions
Infusion Related Reactions were defined as events of headache, fever, facial flushing, pruritus, myalgia, nausea, chest tightness, dyspnea, vomiting, erythema, abdominal discomfort, diaphoresis, shivers, hypertension, hypotension, lightheadedness, palpitations, urticaria and somnolence occurring between the start of a study treatment infusion and one hour after completion of the infusion.
Time frame: 0 to 28 weeks
All Cause Mortality
Tolerability/safety was assessed over the 28-week study period by the incidence of all cause mortality
Time frame: 0 to 28 weeks
Mortality Due to Respiratory Deterioration
Tolerability/safety was assessed over the 28-week study period by the incidence of mortality due to respiratory deterioration
Time frame: 0 to 28 weeks
Mortality Due to Disease Related Events
Number of patients who died over the 28 week study period due to disease-related events (defined as cough, IPF exacerbation, IPF progression and respiratory decline AEs)
Time frame: 0 to 28 weeks