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A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02550873
Recruitment Status : Completed
First Posted : September 16, 2015
Results First Posted : December 14, 2018
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Biological: PRM-151
Other: placebo
Enrollment 117
Recruitment Details One hundred fifty-one (151) patients were screened for the study. Of these, one hundred seventeen (117) were found to be eligible and were randomized. One randomized patient dropped out of the study prior to receiving any study drug.
Pre-assignment Details  
Arm/Group Title PRM-151 10 mg/kg Placebo Open Label PRM-151 10 mg/kg
Hide Arm/Group Description

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

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

Period Title: Randomized Double Blind
Started [1] 78 39 0
Received Treatment 77 39 0
Continue to Open Label Extension 74 37 0
Completed 74 37 0
Not Completed 4 2 0
Reason Not Completed
Adverse Event             3             1             0
Disease progression             1             1             0
[1]
Number of patients randomized
Period Title: Open Label Extension
Started 0 0 111
Completed 0 0 0 [1]
Not Completed 0 0 111
Reason Not Completed
Study ongoing             0             0             111
[1]
Open Label extension is ongoing
Arm/Group Title PRM-151 10 mg/kg Placebo Total
Hide Arm/Group Description

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 77 39 116
Hide Baseline Analysis Population Description
All treated patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 39 participants 116 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  31.2%
14
  35.9%
38
  32.8%
>=65 years
53
  68.8%
25
  64.1%
78
  67.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 39 participants 116 participants
Female
12
  15.6%
10
  25.6%
22
  19.0%
Male
65
  84.4%
29
  74.4%
94
  81.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity/Race Number Analyzed 77 participants 39 participants 116 participants
White
74
  96.1%
39
 100.0%
113
  97.4%
Black/African
1
   1.3%
0
   0.0%
1
   0.9%
Hispanic
1
   1.3%
0
   0.0%
1
   0.9%
Asian
1
   1.3%
0
   0.0%
1
   0.9%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 77 participants 39 participants 116 participants
86.1  (15.2) 87.5  (13.4) 86.5  (14.5)
Years since IPF diagnosis, mean (SD)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 77 participants 39 participants 116 participants
3.74  (2.16) 3.90  (2.62) 3.79  (2.32)
FVC  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 77 participants 39 participants 116 participants
2733  (630) 2763  (654) 2743  (635)
FVC [% predicted]  
Mean (Standard Deviation)
Unit of measure:  Percentage of predicted FVC
Number Analyzed 77 participants 39 participants 116 participants
67.7  (10.9) 67.4  (11.4) 67.6  (11.0)
FEV1/FVC  
Mean (Standard Deviation)
Unit of measure:  Percentage of FEV1/FVC
Number Analyzed 77 participants 39 participants 116 participants
81.2  (5.1) 81.6  (4.7) 81.3  (4.9)
Hemoglobin-corrected DLCO  
Mean (Standard Deviation)
Unit of measure:  Percentage of predicted DLCO
Number Analyzed 77 participants 39 participants 116 participants
40.1  (9.1) 43.2  (10.5) 41.2  (9.7)
6MWD  
Median (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 77 participants 39 participants 116 participants
434.8  (92.5) 457.7  (117.7) 442.5  (101.7)
SpO2 at rest  
Mean (Standard Deviation)
Unit of measure:  Percentage of SpO2
Number Analyzed 77 participants 39 participants 116 participants
95.6  (2.1) 95.5  (1.8) 95.6  (2.0)
IPF Therapy Status at Baseline  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 39 participants 116 participants
Concurrent IPF Therapy
61
  79.2%
30
  76.9%
91
  78.4%
Concurrent pirfenidone
39
  50.6%
22
  56.4%
61
  52.6%
Concurrent nintedanib
22
  28.6%
8
  20.5%
30
  25.9%
No concurrent IPF therapy
16
  20.8%
9
  23.1%
25
  21.6%
IPF therapy naiive
8
  10.4%
7
  17.9%
15
  12.9%
Comorbid Conditions  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants 39 participants 116 participants
GERD
47
  61.0%
16
  41.0%
63
  54.3%
Hypertension
38
  49.4%
14
  35.9%
52
  44.8%
Cardiac Disorders
29
  37.7%
7
  17.9%
36
  31.0%
Coronary Artery Disorders
15
  19.5%
4
  10.3%
19
  16.4%
Emphysema
2
   2.6%
0
   0.0%
2
   1.7%
Pulmonary Hypertension
1
   1.3%
3
   7.7%
4
   3.4%
1.Primary Outcome
Title Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Least Squares Mean (90% Confidence Interval)
Unit of Measure: Percentage of predicted FVC
-2.5
(-3.2 to -1.8)
-4.8
(-5.7 to -3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, Placebo
Comments

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%

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0014
Comments a priori threshold for statistical significance = 0.10
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.3
Confidence Interval (2-Sided) 90%
1.1 to 3.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.72
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in 6-Minute Walk Distance (6MWD)
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Least Squares Mean (90% Confidence Interval)
Unit of Measure: meters
-0.5
(-8.6 to 7.6)
-31.8
(-43.0 to -20.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments This study was not powered to test hypothesis beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.3
Confidence Interval (2-Sided) 90%
17.4 to 45.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.42
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)
Hide Description Mean change from baseline in total lung volume on HRCT using quantitative imaging software.
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.
Arm/Group Title PRM-151 10 mg/kg; No Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo; No Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

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

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 receiving concurrent pirfenidone or nintedanib

Overall Number of Participants Analyzed 14 52 8 26
Least Squares Mean (90% Confidence Interval)
Unit of Measure: milliliters
-103.8
(-234.1 to 26.6)
-108.1
(-184.2 to -31.9)
-197.3
(-341.2 to -53.3)
-201.6
(-305.3 to -97.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg; No Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo; No Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2032
Comments This study was not powered to test hypothesis beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 93.5
Confidence Interval (2-Sided) 90%
-27.7 to 214.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 72.98
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.
Arm/Group Title PRM-151 10 mg/kg; No Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo; No Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

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

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 receiving concurrent pirfenidone or nintedanib

Overall Number of Participants Analyzed 14 52 8 26
Mean (Standard Error)
Unit of Measure: milliliters
49.7  (49.65) 80.9  (29.21) 17.8  (55.26) 49.0  (39.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg; No Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo; No Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4927
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 31.9
Confidence Interval (2-Sided) 90%
-45.0 to 108.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 46.33
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in % of Total Lung Volume of ILA on HRCT
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 14 52 8 26
Least Squares Mean (90% Confidence Interval)
Unit of Measure: percentage of total lung volume
2.6
(-0.9 to 6.0)
3.0
(1.0 to 5.1)
1.5
(-2.4 to 5.4)
1.9
(-0.8 to 4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5835
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.1
Confidence Interval (2-Sided) 90%
-2.2 to 4.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.96
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Volume of Normal Lung on HRCT
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.
Arm/Group Title PRM-151 10 mg/kg; No Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo; No Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 14 52 8 26
Least Squares Mean (90% Confidence Interval)
Unit of Measure: milliliters
-165.2
(-347.2 to 16.8)
-201.1
(-307.6 to -94.5)
-208.8
(-410.1 to -7.5)
-244.7
(-389.9 to -99.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg; No Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo; No Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6707
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 43.6
Confidence Interval (2-Sided) 90%
-126.3 to 213.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 102.28
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in % of Normal Lung on HRCT (%)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 14 52 8 26
Least Squares Mean (90% Confidence Interval)
Unit of Measure: percentage of total lung volume
-2.6
(-6.0 to 0.8)
-3.3
(-5.3 to -1.3)
-1.4
(-5.1 to 2.4)
-2.1
(-4.8 to 0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.2
Confidence Interval (2-Sided) 90%
-4.4 to 1.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.91
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients from the ATS population who had FVC and HRCT data at both the Baseline and Week 28 time points.
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 60 33
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
-0.5027
(-0.6686 to -0.2812)
-0.4570
(-0.6880 to -0.1279)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Other
Comments Correlation analysis
Statistical Test of Hypothesis P-Value 0.0001
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Method Pearson's correlation
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Type of Statistical Test Other
Comments Correlation analysis
Statistical Test of Hypothesis P-Value 0.0069
Comments [Not Specified]
Method Pearson's correlation
Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients with data at baseline and 28 weeks
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

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

Overall Number of Participants Analyzed 13 54 8 27
Measure Type: Count of Participants
Unit of Measure: Participants
Decline in % Predicted FVC ≥ 5%
2
  15.4%
18
  33.3%
2
  25.0%
11
  40.7%
Decline in % Predicted FVC ≥10%
1
   7.7%
1
   1.9%
0
   0.0%
3
  11.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4179
Comments P-Value for decline in % Predicted FVC ≥ 5%. This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2184
Comments P-Value for decline in % predicted FVC ≥ 10%. This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
10.Secondary Outcome
Title Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28.
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients with data at baseline and Week 28
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 13 54 8 27
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease in FVC ≥ 100 mL
5
  38.5%
32
  59.3%
2
  25.0%
16
  59.3%
Decrease in FVC ≥ 200 mL
2
  15.4%
19
  35.2%
1
  12.5%
8
  29.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7773
Comments P-Value for decline in FVC ≥ 100 mL. This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5976
Comments P-Value for decline in FVC ≥ 200 mL. This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
11.Secondary Outcome
Title Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28.
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

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

Overall Number of Participants Analyzed 16 61 9 30
Measure Type: Count of Participants
Unit of Measure: Participants
Increase in % Predicted FVC ≥5%
1
   6.3%
1
   1.6%
0
   0.0%
0
   0.0%
Increase in % Predicted FVC ≥10%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments P-Value for increase in % predicted FVC ≥ 5%. P-Value for an increase in % predicted FVC ≥ 10% not reported. This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
12.Secondary Outcome
Title Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients with FVC data at Baseline and Week 28
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

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

Overall Number of Participants Analyzed 13 54 8 27
Measure Type: Count of Participants
Unit of Measure: Participants
Increase in FVC ≥ 100 mL
1
   7.7%
6
  11.1%
0
   0.0%
0
   0.0%
Increase in FVC ≥ 200 mL
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0508
Comments P-Value for increase in FVC ≥ 100 mL. P-Value for increase in FVC ≥ 200 mL not reported. This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
13.Secondary Outcome
Title Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28.
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects with data at baseline and week 28
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

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

Overall Number of Participants Analyzed 13 54 8 27
Measure Type: Count of Participants
Unit of Measure: Participants
10
  76.9%
35
  64.8%
6
  75.0%
16
  59.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6308
Comments This study was not powered to test hypotheses beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
14.Secondary Outcome
Title Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28.
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects with FVC data at Baseline and Week 28
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 13 54 8 27
Measure Type: Count of Participants
Unit of Measure: Participants
7
  53.8%
16
  29.6%
6
  75.0%
11
  40.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1846
Comments This study was not powered to test hypothesis beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction
15.Secondary Outcome
Title Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PRM-151 10 mg/kg, no Background Therapy PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib Placebo, no Background Therapy Placebo; Pirfenidone or Nintedanib
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 16 61 9 30
Least Squares Mean (90% Confidence Interval)
Unit of Measure: percentage of predicted DLCO
-2.8
(-5.1 to -0.5)
-3.0
(-4.4 to -1.6)
-2.4
(-5.0 to 0.3)
-2.5
(-4.4 to -0.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, no Background Therapy, PRM-151 10 mg/kg IV; Pirfenidone or Nintedanib, Placebo, no Background Therapy, Placebo; Pirfenidone or Nintedanib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7424
Comments This study was not powered to test hypothesis beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept; dependent variable=raw values at each time point; explanatory variables=stratum, treatment, time and treatment by time interaction.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.4
Confidence Interval (2-Sided) 90%
-2.6 to 1.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.31
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Hide Description Tolerability/safety was assessed over the 28-week study period by the number of reported TEAEs
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (All randomized patients who received at least one dose of study treatment)
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
71
  92.2%
36
  92.3%
17.Secondary Outcome
Title Percentage of Subjects Discontinuing Study Drug Due to AEs
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.6%
1
   2.6%
18.Secondary Outcome
Title Percentage of Subjects Reporting Serious Adverse Events (SAEs)
Hide Description Tolerability/safety was assessed over the 28-week study period by incidence of SAEs
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
6
   7.8%
4
  10.3%
19.Secondary Outcome
Title Percentage of Subjects Reporting Respiratory Decline AEs
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
11
  14.3%
4
  10.3%
20.Secondary Outcome
Title Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
4
   5.2%
4
  10.3%
21.Secondary Outcome
Title Percentage of Subjects With Infusion Related Reactions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
Any Infusion Related Reaction
2
   2.6%
1
   2.6%
Dizziness
1
   1.3%
0
   0.0%
Hypertensive crisis
1
   1.3%
1
   2.6%
22.Secondary Outcome
Title All Cause Mortality
Hide Description Tolerability/safety was assessed over the 28-week study period by the incidence of all cause mortality
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.6%
23.Secondary Outcome
Title Mortality Due to Respiratory Deterioration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.6%
24.Secondary Outcome
Title Mortality Due to Disease Related Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
25.Other Pre-specified Outcome
Title Change From Baseline in FVC Volume
Hide Description [Not Specified]
Time Frame 0 to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated subjects
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description:

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

Overall Number of Participants Analyzed 77 39
Least Squares Mean (90% Confidence Interval)
Unit of Measure: milliliters
-127.7
(-181.8 to -73.5)
-242.3
(-317.2 to -167.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PRM-151 10 mg/kg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0416
Comments This study was not powered to test hypothesis beyond the primary endpoint.
Method Mixed Models Analysis
Comments Random intercept and slope; dependent variable=raw values; explanatory variables=stratum, treatment, time and treatment by time interaction.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 114.6
Confidence Interval (2-Sided) 90%
22.2 to 207.1
Parameter Dispersion
Type: Standard Deviation
Value: 56.10
Estimation Comments [Not Specified]
Time Frame 28 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PRM-151 10 mg/kg Placebo
Hide Arm/Group Description

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

Dosing Every 4 weeks

placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks

All-Cause Mortality
PRM-151 10 mg/kg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/77 (0.00%)      1/39 (2.56%)    
Hide Serious Adverse Events
PRM-151 10 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/77 (7.79%)      4/39 (10.26%)    
Cardiac disorders     
Coronary Artery Disease * 1  1/77 (1.30%)  1 0/39 (0.00%)  0
Cardiomyopathy * 1  1/77 (1.30%)  1 0/39 (0.00%)  0
Atrial Fibrillation * 1  0/77 (0.00%)  0 1/39 (2.56%)  1
Infections and infestations     
Lower Respiratory Tract Infection * 1  1/77 (1.30%)  1 0/39 (0.00%)  0
Respiratory Tract Infection * 1  0/77 (0.00%)  0 1/39 (2.56%)  1
Influenza * 1  0/77 (0.00%)  0 1/39 (2.56%)  1
Nervous system disorders     
Embolic Cerebral Infarction * 1  1/77 (1.30%)  1 0/39 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism * 1  1/77 (1.30%)  1 0/39 (0.00%)  0
Idiopathic Pulmonary Fibrosis * 1  1/77 (1.30%)  1 2/39 (5.13%)  3
Dyspnoea * 1  0/77 (0.00%)  0 1/39 (2.56%)  1
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PRM-151 10 mg/kg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/77 (75.32%)      28/39 (71.79%)    
Blood and lymphatic system disorders     
Anemia * 1  2/77 (2.60%)  3 2/39 (5.13%)  5
Gastrointestinal disorders     
Diarrhoea * 1  9/77 (11.69%)  11 2/39 (5.13%)  2
Nausea * 1  5/77 (6.49%)  6 2/39 (5.13%)  2
General disorders     
Fatigue * 1  13/77 (16.88%)  20 4/39 (10.26%)  4
Influenza-like illness * 1  3/77 (3.90%)  4 2/39 (5.13%)  5
Infections and infestations     
Nasopharyngitis * 1  12/77 (15.58%)  15 9/39 (23.08%)  13
Bronchitis * 1  8/77 (10.39%)  8 5/39 (12.82%)  5
Upper respiratory tract infection * 1  7/77 (9.09%)  7 5/39 (12.82%)  5
Respiratory Tract Infection * 1  4/77 (5.19%)  5 2/39 (5.13%)  2
Sinusitis * 1  3/77 (3.90%)  3 3/39 (7.69%)  4
Influenza * 1  3/77 (3.90%)  3 3/39 (7.69%)  3
Investigations     
Aspartate aminotransferase increased * 1  0/77 (0.00%)  0 3/39 (7.69%)  8
Metabolism and nutrition disorders     
Decreased Appetite * 1  4/77 (5.19%)  4 2/39 (5.13%)  2
Hypokalemia * 1  1/77 (1.30%)  1 2/39 (5.13%)  5
Musculoskeletal and connective tissue disorders     
Back Pain * 1  3/77 (3.90%)  3 4/39 (10.26%)  8
Pain in Extremity * 1  4/77 (5.19%)  5 3/39 (7.69%)  4
Arthralgia * 1  3/77 (3.90%)  4 2/39 (5.13%)  5
Nervous system disorders     
Headache * 1  11/77 (14.29%)  15 3/39 (7.69%)  6
Dizziness * 1  6/77 (7.79%)  7 3/39 (7.69%)  4
Psychiatric disorders     
Depression * 1  0/77 (0.00%)  0 2/39 (5.13%)  5
Respiratory, thoracic and mediastinal disorders     
Idiopathic pulmonary fibrosis * 1  11/77 (14.29%)  11 5/39 (12.82%)  6
Cough * 1  14/77 (18.18%)  16 2/39 (5.13%)  2
Dyspnoea * 1  7/77 (9.09%)  8 4/39 (10.26%)  4
Productive Cough * 1  3/77 (3.90%)  3 3/39 (7.69%)  3
Dyspnea exertional * 1  5/77 (6.49%)  6 0/39 (0.00%)  0
Hypoxia * 1  4/77 (5.19%)  5 0/39 (0.00%)  0
Epistaxis * 1  2/77 (2.60%)  3 2/39 (5.13%)  5
Wheezing * 1  2/77 (2.60%)  3 2/39 (5.13%)  5
Oropharyngeal Pain * 1  1/77 (1.30%)  1 2/39 (5.13%)  5
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Study not designed to test secondary outcome measures. Diagnosis of IPF allowed "possible usual interstitial pneumonia." HRCTs read locally, so reads may be heterogeneous. HRCTs are susceptible to inspiratory effort artifacts.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A Publications Committee comprised of Investigators participating in the study and representatives from Promedior was formed to oversee the publication of the study results, which reflected the experience of all participating study centers. Subsequently, individual Investigators may publish results from the study in compliance with their agreement with the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Renu Gupta, MD, Chief Medical Officer
Organization: Promedior Inc.
Phone: 856-722-9824
EMail: rgupta@promedior.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02550873    
Other Study ID Numbers: WA42404
PRM-151-202 ( Other Identifier: Promedior, Inc. )
2014-004782-24 ( EudraCT Number )
First Submitted: August 27, 2015
First Posted: September 16, 2015
Results First Submitted: November 20, 2018
Results First Posted: December 14, 2018
Last Update Posted: March 24, 2021