| Primary | 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. | | Posted | | Least Squares Mean | 90% Confidence Interval | Percentage of predicted FVC | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-2.5(-3.2 to -1.8)
- OG001-4.8(-5.7 to -3.8)
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The sample size calculation was based on the following assumptions: Normal distribution Homogeneity of variance the same in both arms, and for both types of patients Randomization ratio PRM-151:placebo = 2:1 Expected value for patients on pirfenidone or nintedanib = -1.5 Expected value for patients on no other treatment = -3 Expected value for patients on PRM-151 ≥ 0.75 Standard deviation = 5 75% of patients on a stable dose of pirfenidone or nintedanib α=0.10 two-sided Power = 80% | Mixed Models Analysis | Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction | 0.0014 | a priori threshold for statistical significance = 0.10 | Mean Difference (Net) | 2.3 | Standard Error of the Mean | 0.72 | 2-Sided | 90 | 1.1 | 3.5 | |
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| Secondary | Change From Baseline in 6-Minute Walk Distance (6MWD) | | | Posted | | Least Squares Mean | 90% Confidence Interval | meters | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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. | All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points. | Posted | | Least Squares Mean | 90% Confidence Interval | milliliters | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg; No Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients receiving concurrent pirfenidone or nintedanib | | OG002 | Placebo; No Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib | | OG003 |
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| Secondary | 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 | All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points. | Posted | | Mean | Standard Error | milliliters | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg; No Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients receiving concurrent pirfenidone or nintedanib | | OG002 | Placebo; No Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib |
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| Secondary | 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 | All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points. | Posted | | Least Squares Mean | 90% Confidence Interval | percentage of total lung volume | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib |
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| Secondary | 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. | All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points. | Posted | | Least Squares Mean | 90% Confidence Interval | milliliters | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg; No Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks in patients receiving concurrent pirfenidone or nintedanib therapy | | OG002 | Placebo; No Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks in patients not receiving concurrent pirfenidone or nintedanib |
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| Secondary | 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. | All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points. | Posted | | Least Squares Mean | 90% Confidence Interval | percentage of total lung volume | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib |
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| Secondary | 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. | All patients from the ATS population who had FVC and HRCT data at both the Baseline and Week 28 time points. | Posted | | Number | 95% Confidence Interval | Correlation coefficient | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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. | All treated patients with data at baseline and 28 weeks | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28. | | All treated patients with data at baseline and Week 28 | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28. | | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28 | | All treated patients with FVC data at Baseline and Week 28 | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28. | | All treated subjects with data at baseline and week 28 | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28. | | All treated subjects with FVC data at Baseline and Week 28 | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg; Pirfenidone or Nintedanib | Dosing Every 4 weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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). | | Posted | | Least Squares Mean | 90% Confidence Interval | percentage of predicted DLCO | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg, no Background Therapy | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG002 | Placebo, no Background Therapy | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks | | OG003 | Placebo; Pirfenidone or Nintedanib | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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 | Safety population (All randomized patients who received at least one dose of study treatment) | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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 | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | Percentage of Subjects Reporting Serious Adverse Events (SAEs) | Tolerability/safety was assessed over the 28-week study period by incidence of SAEs | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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.
| | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
| |
| Secondary | 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 | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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| Secondary | All Cause Mortality | Tolerability/safety was assessed over the 28-week study period by the incidence of all cause mortality | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
| |
| Secondary | Mortality Due to Respiratory Deterioration | Tolerability/safety was assessed over the 28-week study period by the incidence of mortality due to respiratory deterioration | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
| |
| Secondary | 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) | | Posted | | Count of Participants | | Participants | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
| |
| Other Pre-specified | Change From Baseline in FVC Volume | | | Posted | | Least Squares Mean | 90% Confidence Interval | milliliters | | 0 to 28 weeks | | | | ID | Title | Description |
|---|
| OG000 | PRM-151 10 mg/kg | Dosing Every 4 Weeks PRM-151: PRM-151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks | | OG001 | Placebo | Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks |
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