Trial Outcomes & Findings for A Trial to Evaluate the Efficacy of PRM-151 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT02550873)

NCT ID: NCT02550873

Last Updated: 2022-05-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 117 participants
• Primary outcome timeframe: 0 to 28 weeks
• Results posted on: 2022-05-02

Participant Flow

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.

Participant milestones

Measure	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	Placebo Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Open Label 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
Randomized Double Blind STARTED	78	39	0
Randomized Double Blind Received Treatment	77	39	0
Randomized Double Blind Continue to Open Label Extension	74	37	0
Randomized Double Blind COMPLETED	74	37	0
Randomized Double Blind NOT COMPLETED	4	2	0
Open Label Extension STARTED	0	0	111
Open Label Extension COMPLETED	0	0	0
Open Label Extension NOT COMPLETED	0	0	111

Reasons for withdrawal

Measure	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	Placebo Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Open Label 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
Randomized Double Blind Adverse Event	3	1	0
Randomized Double Blind Disease progression	1	1	0
Open Label Extension Study ongoing	0	0	111

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Total n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	53 Participants n=5 Participants	25 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	29 Participants n=7 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity/Race · White	74 Participants n=5 Participants	39 Participants n=7 Participants	113 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity/Race · Black/African	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity/Race · Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity/Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Weight	86.1 kg STANDARD_DEVIATION 15.2 • n=5 Participants	87.5 kg STANDARD_DEVIATION 13.4 • n=7 Participants	86.5 kg STANDARD_DEVIATION 14.5 • n=5 Participants
Years since IPF diagnosis, mean (SD)	3.74 years STANDARD_DEVIATION 2.16 • n=5 Participants	3.90 years STANDARD_DEVIATION 2.62 • n=7 Participants	3.79 years STANDARD_DEVIATION 2.32 • n=5 Participants
FVC	2733 mL STANDARD_DEVIATION 630 • n=5 Participants	2763 mL STANDARD_DEVIATION 654 • n=7 Participants	2743 mL STANDARD_DEVIATION 635 • n=5 Participants
FVC [% predicted]	67.7 Percentage of predicted FVC STANDARD_DEVIATION 10.9 • n=5 Participants	67.4 Percentage of predicted FVC STANDARD_DEVIATION 11.4 • n=7 Participants	67.6 Percentage of predicted FVC STANDARD_DEVIATION 11.0 • n=5 Participants
FEV1/FVC	81.2 Percentage of FEV1/FVC STANDARD_DEVIATION 5.1 • n=5 Participants	81.6 Percentage of FEV1/FVC STANDARD_DEVIATION 4.7 • n=7 Participants	81.3 Percentage of FEV1/FVC STANDARD_DEVIATION 4.9 • n=5 Participants
Hemoglobin-corrected DLCO	40.1 Percentage of predicted DLCO STANDARD_DEVIATION 9.1 • n=5 Participants	43.2 Percentage of predicted DLCO STANDARD_DEVIATION 10.5 • n=7 Participants	41.2 Percentage of predicted DLCO STANDARD_DEVIATION 9.7 • n=5 Participants
6MWD	434.8 meters STANDARD_DEVIATION 92.5 • n=5 Participants	457.7 meters STANDARD_DEVIATION 117.7 • n=7 Participants	442.5 meters STANDARD_DEVIATION 101.7 • n=5 Participants
SpO2 at rest	95.6 Percentage of SpO2 STANDARD_DEVIATION 2.1 • n=5 Participants	95.5 Percentage of SpO2 STANDARD_DEVIATION 1.8 • n=7 Participants	95.6 Percentage of SpO2 STANDARD_DEVIATION 2.0 • n=5 Participants
IPF Therapy Status at Baseline Concurrent IPF Therapy	61 Participants n=5 Participants	30 Participants n=7 Participants	91 Participants n=5 Participants
IPF Therapy Status at Baseline Concurrent pirfenidone	39 Participants n=5 Participants	22 Participants n=7 Participants	61 Participants n=5 Participants
IPF Therapy Status at Baseline Concurrent nintedanib	22 Participants n=5 Participants	8 Participants n=7 Participants	30 Participants n=5 Participants
IPF Therapy Status at Baseline No concurrent IPF therapy	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
IPF Therapy Status at Baseline IPF therapy naiive	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Comorbid Conditions GERD	47 Participants n=5 Participants	16 Participants n=7 Participants	63 Participants n=5 Participants
Comorbid Conditions Hypertension	38 Participants n=5 Participants	14 Participants n=7 Participants	52 Participants n=5 Participants
Comorbid Conditions Cardiac Disorders	29 Participants n=5 Participants	7 Participants n=7 Participants	36 Participants n=5 Participants
Comorbid Conditions Coronary Artery Disorders	15 Participants n=5 Participants	4 Participants n=7 Participants	19 Participants n=5 Participants
Comorbid Conditions Emphysema	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Comorbid Conditions Pulmonary Hypertension	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 28 weeks

Population: All treated patients

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.

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Change From Baseline in Forced Vital Capacity (FVC) [% Predicted]	-2.5 Percentage of predicted FVC Interval -3.2 to -1.8	-4.8 Percentage of predicted FVC Interval -5.7 to -3.8	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated patients

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Change From Baseline in 6-Minute Walk Distance (6MWD)	-0.5 meters Interval -8.6 to 7.6	-31.8 meters Interval -43.0 to -20.5	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.

Mean change from baseline in total lung volume on HRCT using quantitative imaging software.

Outcome measures

Measure	PRM-151 10 mg/kg n=14 Participants 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	Placebo n=52 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=26 Participants 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
Change From Baseline in Total Lung Volume on High-resolution Computed Tomography (HRCT)	-103.8 milliliters Interval -234.1 to 26.6	-108.1 milliliters Interval -184.2 to -31.9	-197.3 milliliters Interval -341.2 to -53.3	-201.6 milliliters Interval -305.3 to -97.9

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.

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

Outcome measures

Measure	PRM-151 10 mg/kg n=14 Participants 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	Placebo n=52 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=26 Participants 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
Change From Baseline in Volume of Interstitial Lung Abnormalities (ILA) on HRCT	49.7 milliliters Standard Error 49.65	80.9 milliliters Standard Error 29.21	17.8 milliliters Standard Error 55.26	49.0 milliliters Standard Error 39.64

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.

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

Outcome measures

Measure	PRM-151 10 mg/kg n=14 Participants 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	Placebo n=52 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=26 Participants 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
Change From Baseline in % of Total Lung Volume of ILA on HRCT	2.6 percentage of total lung volume Interval -0.9 to 6.0	3.0 percentage of total lung volume Interval 1.0 to 5.1	1.5 percentage of total lung volume Interval -2.4 to 5.4	1.9 percentage of total lung volume Interval -0.8 to 4.7

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.

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.

Outcome measures

Measure	PRM-151 10 mg/kg n=14 Participants 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	Placebo n=52 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=26 Participants 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
Change From Baseline in Volume of Normal Lung on HRCT	-165.2 milliliters Interval -347.2 to 16.8	-201.1 milliliters Interval -307.6 to -94.5	-208.8 milliliters Interval -410.1 to -7.5	-244.7 milliliters Interval -389.9 to -99.4

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All patients from the ATS population who had HRCT data at both the Baseline and Week 28 time points.

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.

Outcome measures

Measure	PRM-151 10 mg/kg n=14 Participants 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	Placebo n=52 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=26 Participants 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
Change From Baseline in % of Normal Lung on HRCT (%)	-2.6 percentage of total lung volume Interval -6.0 to 0.8	-3.3 percentage of total lung volume Interval -5.3 to -1.3	-1.4 percentage of total lung volume Interval -5.1 to 2.4	-2.1 percentage of total lung volume Interval -4.8 to 0.7

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All patients from the ATS population who had FVC and HRCT data at both the Baseline and Week 28 time points.

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.

Outcome measures

Measure	PRM-151 10 mg/kg n=60 Participants 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	Placebo n=33 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Correlation Between Mean Change From Baseline in FVC [% Predicted] and Mean Change From Baseline in ILA	-0.5027 Correlation coefficient Interval -0.6686 to -0.2812	-0.4570 Correlation coefficient Interval -0.688 to -0.1279	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated patients with data at baseline and 28 weeks

Pulmonary Function Tests for the Proportion (%) of subjects with a decline in FVC% predicted of ≥ 5% and ≥ 10% from Baseline to Week 28.

Outcome measures

Measure	PRM-151 10 mg/kg n=13 Participants 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	Placebo n=54 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=27 Participants 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
Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28. Decline in % Predicted FVC ≥ 5%	2 Participants	18 Participants	2 Participants	11 Participants
Number of Subjects With a Decline in FVC [% Predicted] of ≥ 5% and ≥ 10% From Baseline to Week 28. Decline in % Predicted FVC ≥10%	1 Participants	1 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated patients with data at baseline and Week 28

Outcome measures

Measure	PRM-151 10 mg/kg n=13 Participants 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	Placebo n=54 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=27 Participants 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
Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28. Decrease in FVC ≥ 100 mL	5 Participants	32 Participants	2 Participants	16 Participants
Number of Subjects With a Decline in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28. Decrease in FVC ≥ 200 mL	2 Participants	19 Participants	1 Participants	8 Participants

SECONDARY outcome

Timeframe: 0 to 28 weeks

Outcome measures

Measure	PRM-151 10 mg/kg n=16 Participants 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	Placebo n=61 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=9 Participants 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	Placebo; Pirfenidone or Nintedanib n=30 Participants 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
Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28. Increase in % Predicted FVC ≥5%	1 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With an Increase in FVC [% Predicted] of ≥ 5% and ≥10% From Baseline to Week 28. Increase in % Predicted FVC ≥10%	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated patients with FVC data at Baseline and Week 28

Outcome measures

Measure	PRM-151 10 mg/kg n=13 Participants 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	Placebo n=54 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=27 Participants 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
Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28 Increase in FVC ≥ 100 mL	1 Participants	6 Participants	0 Participants	0 Participants
Number of Subjects With an Increase in FVC of ≥ 100 mL and ≥ 200 mL From Baseline to Week 28 Increase in FVC ≥ 200 mL	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated subjects with data at baseline and week 28

Outcome measures

Measure	PRM-151 10 mg/kg n=13 Participants 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	Placebo n=54 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=27 Participants 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
Number of Subjects With Stable Disease, Defined as a Change in FVC [% Predicted] of < 5% From Baseline to Week 28.	10 Participants	35 Participants	6 Participants	16 Participants

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated subjects with FVC data at Baseline and Week 28

Outcome measures

Measure	PRM-151 10 mg/kg n=13 Participants 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	Placebo n=54 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=8 Participants 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	Placebo; Pirfenidone or Nintedanib n=27 Participants 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
Number of Subjects With Stable Disease, Defined as a Change in FVC of < 100 mL From Baseline to Week 28.	7 Participants	16 Participants	6 Participants	11 Participants

SECONDARY outcome

Timeframe: 0 to 28 weeks

Pulmonary Function Tests to discern the mean change from Baseline to Week 28 in % predicted diffusion capacity of carbon monoxide (DLCO).

Outcome measures

Measure	PRM-151 10 mg/kg n=16 Participants 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	Placebo n=61 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	Placebo; No Background Therapy n=9 Participants 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	Placebo; Pirfenidone or Nintedanib n=30 Participants 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
Change From Baseline in % Predicted Diffusion Capacity of Carbon Monoxide (DLCO).	-2.8 percentage of predicted DLCO Interval -5.1 to -0.5	-3.0 percentage of predicted DLCO Interval -4.4 to -1.6	-2.4 percentage of predicted DLCO Interval -5.0 to 0.3	-2.5 percentage of predicted DLCO Interval -4.4 to -0.7

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population (All randomized patients who received at least one dose of study treatment)

Tolerability/safety was assessed over the 28-week study period by the number of reported TEAEs

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)	71 Participants	36 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

Tolerability/safety was assessed over the 28-week study period by the proportion of subjects who discontinued study drug due to AEs

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Percentage of Subjects Discontinuing Study Drug Due to AEs	2 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

Tolerability/safety was assessed over the 28-week study period by incidence of SAEs

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Percentage of Subjects Reporting Serious Adverse Events (SAEs)	6 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

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.

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Percentage of Subjects Reporting Respiratory Decline AEs	11 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

Tolerability/safety was assessed over the 28-week study period by the number of reported serious respiratory decline AEs

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Percentage of Subjects Reporting Respiratory Decline SAEs [Safety and Tolerability]	4 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: All treated patients

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.

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Percentage of Subjects With Infusion Related Reactions Any Infusion Related Reaction	2 Participants	1 Participants	—	—
Percentage of Subjects With Infusion Related Reactions Dizziness	1 Participants	0 Participants	—	—
Percentage of Subjects With Infusion Related Reactions Hypertensive crisis	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

Tolerability/safety was assessed over the 28-week study period by the incidence of all cause mortality

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
All Cause Mortality	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

Tolerability/safety was assessed over the 28-week study period by the incidence of mortality due to respiratory deterioration

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Mortality Due to Respiratory Deterioration	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: 0 to 28 weeks

Population: Safety population

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)

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Mortality Due to Disease Related Events	0 Participants	0 Participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 0 to 28 weeks

Population: All treated subjects

Outcome measures

Measure	PRM-151 10 mg/kg n=77 Participants 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	Placebo n=39 Participants Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks	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	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 in patients receiving concurrent pirfenidone or nintedanib
Change From Baseline in FVC Volume	-127.7 milliliters Interval -181.8 to -73.5	-242.3 milliliters Interval -317.2 to -167.3	—	—

Adverse Events

PRM-151 10 mg/kg

Serious events: 6 serious events

Other events: 58 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 28 other events

Deaths: 1 deaths

Serious adverse events

Measure	PRM-151 10 mg/kg n=77 participants at risk 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	Placebo n=39 participants at risk Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
Infections and infestations Lower Respiratory Tract Infection	1.3% 1/77 • Number of events 1 • 28 Weeks	0.00% 0/39 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	1.3% 1/77 • Number of events 1 • 28 Weeks	0.00% 0/39 • 28 Weeks
Nervous system disorders Embolic Cerebral Infarction	1.3% 1/77 • Number of events 1 • 28 Weeks	0.00% 0/39 • 28 Weeks
Cardiac disorders Coronary Artery Disease	1.3% 1/77 • Number of events 1 • 28 Weeks	0.00% 0/39 • 28 Weeks
Cardiac disorders Cardiomyopathy	1.3% 1/77 • Number of events 1 • 28 Weeks	0.00% 0/39 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Idiopathic Pulmonary Fibrosis	1.3% 1/77 • Number of events 1 • 28 Weeks	5.1% 2/39 • Number of events 3 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/77 • 28 Weeks	2.6% 1/39 • Number of events 1 • 28 Weeks
Infections and infestations Respiratory Tract Infection	0.00% 0/77 • 28 Weeks	2.6% 1/39 • Number of events 1 • 28 Weeks
Cardiac disorders Atrial Fibrillation	0.00% 0/77 • 28 Weeks	2.6% 1/39 • Number of events 1 • 28 Weeks
Infections and infestations Influenza	0.00% 0/77 • 28 Weeks	2.6% 1/39 • Number of events 1 • 28 Weeks

Other adverse events

Measure	PRM-151 10 mg/kg n=77 participants at risk 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	Placebo n=39 participants at risk Dosing Every 4 weeks placebo: Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	14.3% 11/77 • Number of events 11 • 28 Weeks	12.8% 5/39 • Number of events 6 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Cough	18.2% 14/77 • Number of events 16 • 28 Weeks	5.1% 2/39 • Number of events 2 • 28 Weeks
General disorders Fatigue	16.9% 13/77 • Number of events 20 • 28 Weeks	10.3% 4/39 • Number of events 4 • 28 Weeks
Infections and infestations Nasopharyngitis	15.6% 12/77 • Number of events 15 • 28 Weeks	23.1% 9/39 • Number of events 13 • 28 Weeks
Nervous system disorders Headache	14.3% 11/77 • Number of events 15 • 28 Weeks	7.7% 3/39 • Number of events 6 • 28 Weeks
Gastrointestinal disorders Diarrhoea	11.7% 9/77 • Number of events 11 • 28 Weeks	5.1% 2/39 • Number of events 2 • 28 Weeks
Infections and infestations Bronchitis	10.4% 8/77 • Number of events 8 • 28 Weeks	12.8% 5/39 • Number of events 5 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 7/77 • Number of events 8 • 28 Weeks	10.3% 4/39 • Number of events 4 • 28 Weeks
Infections and infestations Upper respiratory tract infection	9.1% 7/77 • Number of events 7 • 28 Weeks	12.8% 5/39 • Number of events 5 • 28 Weeks
Musculoskeletal and connective tissue disorders Back Pain	3.9% 3/77 • Number of events 3 • 28 Weeks	10.3% 4/39 • Number of events 8 • 28 Weeks
Gastrointestinal disorders Nausea	6.5% 5/77 • Number of events 6 • 28 Weeks	5.1% 2/39 • Number of events 2 • 28 Weeks
Infections and infestations Respiratory Tract Infection	5.2% 4/77 • Number of events 5 • 28 Weeks	5.1% 2/39 • Number of events 2 • 28 Weeks
Infections and infestations Sinusitis	3.9% 3/77 • Number of events 3 • 28 Weeks	7.7% 3/39 • Number of events 4 • 28 Weeks
Infections and infestations Influenza	3.9% 3/77 • Number of events 3 • 28 Weeks	7.7% 3/39 • Number of events 3 • 28 Weeks
Metabolism and nutrition disorders Decreased Appetite	5.2% 4/77 • Number of events 4 • 28 Weeks	5.1% 2/39 • Number of events 2 • 28 Weeks
Musculoskeletal and connective tissue disorders Pain in Extremity	5.2% 4/77 • Number of events 5 • 28 Weeks	7.7% 3/39 • Number of events 4 • 28 Weeks
Nervous system disorders Dizziness	7.8% 6/77 • Number of events 7 • 28 Weeks	7.7% 3/39 • Number of events 4 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Productive Cough	3.9% 3/77 • Number of events 3 • 28 Weeks	7.7% 3/39 • Number of events 3 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	6.5% 5/77 • Number of events 6 • 28 Weeks	0.00% 0/39 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Hypoxia	5.2% 4/77 • Number of events 5 • 28 Weeks	0.00% 0/39 • 28 Weeks
Musculoskeletal and connective tissue disorders Arthralgia	3.9% 3/77 • Number of events 4 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
General disorders Influenza-like illness	3.9% 3/77 • Number of events 4 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
Blood and lymphatic system disorders Anemia	2.6% 2/77 • Number of events 3 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 2/77 • Number of events 3 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Wheezing	2.6% 2/77 • Number of events 3 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
Metabolism and nutrition disorders Hypokalemia	1.3% 1/77 • Number of events 1 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	1.3% 1/77 • Number of events 1 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks
Investigations Aspartate aminotransferase increased	0.00% 0/77 • 28 Weeks	7.7% 3/39 • Number of events 8 • 28 Weeks
Psychiatric disorders Depression	0.00% 0/77 • 28 Weeks	5.1% 2/39 • Number of events 5 • 28 Weeks

Additional Information

Renu Gupta, MD, Chief Medical Officer

Promedior Inc.

Phone: 856-722-9824

Email: rgupta@promedior.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER