Trial Outcomes & Findings for JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF (NCT NCT03538301)

Last Updated: 2023-12-11

Results Overview

The number of participants with TEAEs leading to discontinuation from the study treatment. The Safety Population (including all participants who received at least one dose of study treatment) is presented. TEAE = treatment-emergent adverse event

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

123 participants

Primary outcome timeframe

Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks

Results posted on

2023-12-11

Participant Flow

Diagnosis of idiopathic pulmonary fibrosis within 5 years before Visit 1a, confirmed by the Principal Investigator (PI) using American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines

Participant milestones

Participant milestones
Measure	Placebo Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Overall Study STARTED	42	41	40
Overall Study COMPLETED	31	29	28
Overall Study NOT COMPLETED	11	12	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Overall Study Adverse Event	1	4	4
Overall Study Death	1	1	0
Overall Study Physician Decision	0	1	0
Overall Study Protocol Violation	0	0	1
Overall Study Terminated Early from the Study due to COVID-19 Impact	9	6	7

Baseline Characteristics

JUNIPER: A Phase 2 Study to Evaluate the Safety, Biological Activity, and PK of ND-L02-s0201 in Subjects With IPF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	Total n=123 Participants Total of all reporting groups
Body mass index group Underweight (below 18.5)	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Body mass index group Normal (18.5 - 24.9)	12 Participants n=99 Participants	11 Participants n=107 Participants	10 Participants n=206 Participants	33 Participants n=7 Participants
Age, Continuous	68.7 years STANDARD_DEVIATION 6.16 • n=99 Participants	68.9 years STANDARD_DEVIATION 6.22 • n=107 Participants	69.2 years STANDARD_DEVIATION 6.53 • n=206 Participants	68.9 years STANDARD_DEVIATION 6.25 • n=7 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	7 Participants n=107 Participants	6 Participants n=206 Participants	18 Participants n=7 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	34 Participants n=107 Participants	34 Participants n=206 Participants	105 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants	11 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=99 Participants	39 Participants n=107 Participants	36 Participants n=206 Participants	112 Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	7 Participants n=99 Participants	10 Participants n=107 Participants	7 Participants n=206 Participants	24 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=7 Participants
Race (NIH/OMB) White	34 Participants n=99 Participants	29 Participants n=107 Participants	31 Participants n=206 Participants	94 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=7 Participants
Smoking History Yes	26 Participants n=99 Participants	27 Participants n=107 Participants	26 Participants n=206 Participants	79 Participants n=7 Participants
Smoking History No	16 Participants n=99 Participants	14 Participants n=107 Participants	14 Participants n=206 Participants	44 Participants n=7 Participants
Background Standard of Care Nintedanib	17 Participants n=99 Participants	17 Participants n=107 Participants	16 Participants n=206 Participants	50 Participants n=7 Participants
Background Standard of Care Pirfenidone	15 Participants n=99 Participants	14 Participants n=107 Participants	14 Participants n=206 Participants	43 Participants n=7 Participants
Background Standard of Care None	10 Participants n=99 Participants	10 Participants n=107 Participants	10 Participants n=206 Participants	30 Participants n=7 Participants
Height	172.399 centimeters STANDARD_DEVIATION 6.5281 • n=99 Participants	172.316 centimeters STANDARD_DEVIATION 10.5278 • n=107 Participants	171.519 centimeters STANDARD_DEVIATION 9.2947 • n=206 Participants	172.085 centimeters STANDARD_DEVIATION 8.8564 • n=7 Participants
Weight	85.579 kilograms STANDARD_DEVIATION 15.4326 • n=99 Participants	84.234 kilograms STANDARD_DEVIATION 19.0174 • n=107 Participants	82.255 kilograms STANDARD_DEVIATION 17.6139 • n=206 Participants	84.050 kilograms STANDARD_DEVIATION 17.3109 • n=7 Participants
Body mass index (kg/m^2)	28.765 kg/m^2 STANDARD_DEVIATION 4.7625 • n=99 Participants	28.093 kg/m^2 STANDARD_DEVIATION 4.3072 • n=107 Participants	27.780 kg/m^2 STANDARD_DEVIATION 4.5129 • n=206 Participants	28.221 kg/m^2 STANDARD_DEVIATION 4.5151 • n=7 Participants
Body mass index group Overweight (25 - 29.9)	15 Participants n=99 Participants	17 Participants n=107 Participants	22 Participants n=206 Participants	54 Participants n=7 Participants
Body mass index group Obese (30 and above)	15 Participants n=99 Participants	13 Participants n=107 Participants	8 Participants n=206 Participants	36 Participants n=7 Participants
Baseline Pulse Oximetry (%)	96.5 % of oxygen saturated hemoglobin STANDARD_DEVIATION 2.11 • n=99 Participants	96.6 % of oxygen saturated hemoglobin STANDARD_DEVIATION 1.99 • n=107 Participants	96.9 % of oxygen saturated hemoglobin STANDARD_DEVIATION 1.93 • n=206 Participants	96.7 % of oxygen saturated hemoglobin STANDARD_DEVIATION 2.00 • n=7 Participants
Baseline Forced Vital Capacity	2.861 litres STANDARD_DEVIATION 0.7214 • n=99 Participants	3.012 litres STANDARD_DEVIATION 0.6866 • n=107 Participants	2.890 litres STANDARD_DEVIATION 0.7562 • n=206 Participants	2.921 litres STANDARD_DEVIATION 0.7188 • n=7 Participants
Baseline Percent Predicted Forced Vital Capacity (%)	73.943 % of total normal FVC STANDARD_DEVIATION 17.0078 • n=99 Participants	79.319 % of total normal FVC STANDARD_DEVIATION 14.9940 • n=107 Participants	76.658 % of total normal FVC STANDARD_DEVIATION 18.1270 • n=206 Participants	76.618 % of total normal FVC STANDARD_DEVIATION 16.7595 • n=7 Participants
Baseline Forced Expiratory Volume in 1 second	2.270 litres STANDARD_DEVIATION 0.5603 • n=99 Participants	2.380 litres STANDARD_DEVIATION 0.5345 • n=107 Participants	2.274 litres STANDARD_DEVIATION 0.5890 • n=206 Participants	2.308 litres STANDARD_DEVIATION 0.5592 • n=7 Participants
Baseline Percent Predicted Forced Expiratory Volume	76.890 % of normal FEV STANDARD_DEVIATION 17.8868 • n=99 Participants	81.959 % of normal FEV STANDARD_DEVIATION 14.8182 • n=107 Participants	78.766 % of normal FEV STANDARD_DEVIATION 17.6653 • n=206 Participants	79.190 % of normal FEV STANDARD_DEVIATION 16.8442 • n=7 Participants
Baseline Ratio of Forced Expiratory Volume in 1 second/Forced Vital Capacity	0.795 ratio STANDARD_DEVIATION 0.0501 • n=99 Participants	0.794 ratio STANDARD_DEVIATION 0.0383 • n=107 Participants	0.787 ratio STANDARD_DEVIATION 0.0450 • n=206 Participants	0.792 ratio STANDARD_DEVIATION 0.0445 • n=7 Participants
Baseline Diffusion Capacity of the Lung for Carbon Monoxide Corrected for Hemoglobin	12.574 mL/min/mmHg STANDARD_DEVIATION 3.9023 • n=99 Participants	12.972 mL/min/mmHg STANDARD_DEVIATION 3.6453 • n=107 Participants	12.391 mL/min/mmHg STANDARD_DEVIATION 3.3503 • n=206 Participants	12.647 mL/min/mmHg STANDARD_DEVIATION 3.6223 • n=7 Participants
Baseline Hemoglobin Corrected percent predicted DLCO	51.762 % of normal DLCO STANDARD_DEVIATION 14.7970 • n=99 Participants	53.739 % of normal DLCO STANDARD_DEVIATION 13.1901 • n=107 Participants	51.914 % of normal DLCO STANDARD_DEVIATION 12.6957 • n=206 Participants	52.471 % of normal DLCO STANDARD_DEVIATION 13.5264 • n=7 Participants
Eligibility Criteria Based on high resolution computed tomography Definite UIP	30 Participants n=99 Participants	26 Participants n=107 Participants	22 Participants n=206 Participants	78 Participants n=7 Participants
Eligibility Criteria Based on high resolution computed tomography Consistent with UIP	6 Participants n=99 Participants	10 Participants n=107 Participants	11 Participants n=206 Participants	27 Participants n=7 Participants
Eligibility Criteria Based on high resolution computed tomography Possible UIP	1 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants
Eligibility Criteria Based on high resolution computed tomography Inconsistent with UIP	5 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants	17 Participants n=7 Participants
Eligibility Criteria Based on high resolution computed tomography Unknown	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Duration of idiopathic pulmonary fibrosis	28.227 months STANDARD_DEVIATION 17.4342 • n=99 Participants	24.678 months STANDARD_DEVIATION 16.3543 • n=107 Participants	27.272 months STANDARD_DEVIATION 15.7152 • n=206 Participants	26.734 months STANDARD_DEVIATION 16.4642 • n=7 Participants
GAP IPF Stage I (0 to 3 points. This stage has the lowest risk of mortality	24 Participants n=99 Participants	29 Participants n=107 Participants	25 Participants n=206 Participants	78 Participants n=7 Participants
GAP IPF Stage II (4 to 5 points. This stage has a moderate risk of mortality)	17 Participants n=99 Participants	11 Participants n=107 Participants	15 Participants n=206 Participants	43 Participants n=7 Participants
GAP IPF Stage III (6 to 8 points. This stage has the highest risk of mortality)	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants
Risk of Mortality at 1-year	14.726 risk ratio STANDARD_DEVIATION 7.1570 • n=99 Participants	12.584 risk ratio STANDARD_DEVIATION 4.9287 • n=107 Participants	13.930 risk ratio STANDARD_DEVIATION 6.0984 • n=206 Participants	13.753 risk ratio STANDARD_DEVIATION 6.1532 • n=7 Participants
Risk of Mortality at 2-year	28.505 risk ratio STANDARD_DEVIATION 12.5204 • n=99 Participants	24.922 risk ratio STANDARD_DEVIATION 9.0103 • n=107 Participants	27.233 risk ratio STANDARD_DEVIATION 11.0164 • n=206 Participants	26.897 risk ratio STANDARD_DEVIATION 10.9697 • n=7 Participants
Risk of Mortality at 3-year	40.335 risk ratio STANDARD_DEVIATION 15.9727 • n=99 Participants	36.014 risk ratio STANDARD_DEVIATION 11.9575 • n=107 Participants	38.869 risk ratio STANDARD_DEVIATION 14.4372 • n=206 Participants	38.418 risk ratio STANDARD_DEVIATION 14.2311 • n=7 Participants

PRIMARY outcome

Timeframe: Change in the incidence and severity of adverse events related to study treatment from baseline to 24 weeks

Population: Safety Population (includes all participants who received at least one dose of study treatment)

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Number of Participants Discontinuing Study Treatment Due to TEAEs	1 Participants	3 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Slope in FVC from Baseline to Week 24 (measured in L/week). The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. Slope and standard error are presented. The slope is approximated as least square mean/24 weeks. FVC = forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Rate of Decline in FVC From Baseline to Week 24	-0.003366 litres/week Standard Error 0.0014272	-0.007519 litres/week Standard Error 0.0015285	-0.005478 litres/week Standard Error 0.0015400

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Slope in ppFVC from Baseline to Week 24 (measured in %/week). The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. Slope and standard error are presented. The slope is approximated as least square mean/24 weeks. ppFVC = percent predicted forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Rate of Decline in ppFVC From Baseline to Week 24	-0.096455 %/week Standard Error 0.0373658	-0.187694 %/week Standard Error 0.0400588	-0.136051 %/week Standard Error 0.0403636

SECONDARY outcome

Timeframe: Baseline to Week 24

Absolute and Relative Change in FVC (L) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. FVC = forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Absolute and Relative Change in FVC (L) From Baseline to Week 24 Baseline FVC (L)	2.8754 litres Standard Error 0.11079	3.0242 litres Standard Error 0.11207	2.9032 litres Standard Error 0.11328
Absolute and Relative Change in FVC (L) From Baseline to Week 24 Week 24 FVC (L)	2.7946 litres Standard Error 0.10946	2.8438 litres Standard Error 0.11144	2.7717 litres Standard Error 0.11253
Absolute and Relative Change in FVC (L) From Baseline to Week 24 Change from Baseline to Week 24 in FVC (L)	-0.0808 litres Standard Error 0.03425	-0.1805 litres Standard Error 0.03668	-0.1315 litres Standard Error 0.03696

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Percent Change in FVC from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. FVC = forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Percent Change in FVC From Baseline to Week 24	-3.10 percentage Standard Error 4.793	-5.64 percentage Standard Error 4.488	-4.23 percentage Standard Error 4.723

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Absolute and Relative Change in ppFVC (%) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. ppFVC = percent predicted forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Absolute and Relative Change in ppFVC (%) From Baseline to Week 24 Baseline ppFVC	74.5701 percent Standard Error 2.54894	79.8896 percent Standard Error 2.57837	77.2260 percent Standard Error 2.60623
Absolute and Relative Change in ppFVC (%) From Baseline to Week 24 Week 24 ppFVC	72.2552 percent Standard Error 2.58376	75.3849 percent Standard Error 2.63382	73.9607 percent Standard Error 2.65995
Absolute and Relative Change in ppFVC (%) From Baseline to Week 24 Change from Baseline to Week 24 in ppFVC	-2.3149 percent Standard Error 0.89678	-4.5046 percent Standard Error 0.96141	-3.2652 percent Standard Error 0.96873

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Percent Change in ppFVC from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. ppFVC = percent predicted forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Percent Change in ppFVC From Baseline to Week 24	-3.10 percentage Standard Error 4.793	-5.64 percentage Standard Error 4.488	-4.23 percentage Standard Error 4.723

SECONDARY outcome

Timeframe: Baseline to Visit 14 (Day 169)

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization) with FVC assessment at Visit 14

Proportion of participants with an FVC response defined as either having improvement or a decline by 0 to less than or equal to 5%, more than 5% to less than or equal to 10%, and more than 10% at Visit 14 (Day 169). Participants with an FVC response were defined as improvement in FVC (ie, FVC value higher than baseline) or a decline of less than or equal to 10% from baseline. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. FVC = forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Summary of Study Treatment Response of FVC Improvement	9 Participants	7 Participants	5 Participants
Summary of Study Treatment Response of FVC Decline ≥0% to ≤5%	10 Participants	6 Participants	10 Participants
Summary of Study Treatment Response of FVC Decline >5% to ≤10%	8 Participants	6 Participants	6 Participants
Summary of Study Treatment Response of FVC Decline >10%	3 Participants	7 Participants	4 Participants
Summary of Study Treatment Response of FVC Test not done	12 Participants	15 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline to Visit 14 (Day 169)

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization) with ppFVC assessment at Visit 14

Proportion of participants with an ppFVC response defined as either having improvement or a decline by 0 to less than or equal to 5%, greater than 5% to less than or equal to 10%, and greater than 10% at Visit 14 (Day 169). Participants with an ppFVC response were defined as improvement in ppFVC (ie, ppFVC value higher than baseline) or a decline of less than or equal to 10% from baseline. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented. ppFVC = percent predicted forced vital capacity

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Summary of Study Treatment Response of ppFVC Improvement	9 Participants	7 Participants	5 Participants
Summary of Study Treatment Response of ppFVC Decline ≥0% to ≤5%	10 Participants	6 Participants	10 Participants
Summary of Study Treatment Response of ppFVC Decline >5% to ≤10%	8 Participants	6 Participants	6 Participants
Summary of Study Treatment Response of ppFVC Decline >10%	3 Participants	7 Participants	4 Participants
Summary of Study Treatment Response of ppFVC Test not done	12 Participants	15 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Change in diffusion capacity of the lung for carbon monoxide (DLCO) and DLCO corrected for hemoglobin (mL/min/mmHg) from Baseline to Week 24. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 Change from Baseline to Week 24 in DLCO Not Corrected for Hemoglobin (mL/min/mmHg)	-0.8691 mL/min/mmHg Standard Error 0.26307	-0.7551 mL/min/mmHg Standard Error 0.27406	-0.3131 mL/min/mmHg Standard Error 0.27721
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 Baseline DLCO Corrected for Hemoglobin (mL/min/mmHg)	12.6709 mL/min/mmHg Standard Error 0.56489	13.0723 mL/min/mmHg Standard Error 0.57141	12.4800 mL/min/mmHg Standard Error 0.57759
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 Week 24 DLCO Corrected for Hemoglobin (mL/min/mmHg)	11.7541 mL/min/mmHg Standard Error 0.58748	12.3015 mL/min/mmHg Standard Error 0.59845	12.2669 mL/min/mmHg Standard Error 0.60460
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 Change from Baseline to Week 24 in DLCO Corrected for Hemoglobin (mL/min/mmHg)	-0.9169 mL/min/mmHg Standard Error 0.26950	-0.7708 mL/min/mmHg Standard Error 0.28085	-0.2131 mL/min/mmHg Standard Error 0.28408
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 Baseline DLCO Not Corrected for Hemoglobin (mL/min/mmHg)	12.4411 mL/min/mmHg Standard Error 0.55897	12.9860 mL/min/mmHg Standard Error 0.56543	12.3792 mL/min/mmHg Standard Error 0.57155
Change in DLCO and DLCO Corrected for Hemoglobin From Baseline to Week 24 Week 24 DLCO Not Corrected for Hemoglobin (mL/min/mmHg)	11.5720 mL/min/mmHg Standard Error 0.57137	12.2308 mL/min/mmHg Standard Error 0.58226	12.0661 mL/min/mmHg Standard Error 0.58804

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Changes of interstitial lung abnormalities as measured by high-resolution computed tomography (HRCT; ie, change in parenchymal feature \[Baseline to Week 24\]), as determined by qualitative assessment (central radiologist) and quantitative analysis (Quantitative Lung Fibrosis - QLF analysis). Quantitative HRCT parameters included the following: * Quantitative Lung Fibrosis (QLF) score (% of whole lung field volume) * Ground glass opacity (GGO) (% of whole lung field volume) * Reticulation (% of whole lung field volume) * Honeycombing (% of whole lung field volume) * Normal lung (% of whole lung field volume) * Emphysema (low attenuation area \[LAA\]; % of whole lung field volume) The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Baseline Reticulation (% of whole lung field volume)	27.46 percentage Standard Error 1.890	23.69 percentage Standard Error 2.108	24.03 percentage Standard Error 1.943
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Baseline QLF Score (% of whole lung field volume)	33.59 percentage Standard Error 2.189	27.45 percentage Standard Error 2.441	27.22 percentage Standard Error 2.249
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Week 24 QLF Score (% of whole lung field volume)	35.87 percentage Standard Error 2.195	29.24 percentage Standard Error 2.447	30.89 percentage Standard Error 2.258
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Change from Baseline to Week 24 in QLF Score (% of whole lung field volume)	2.28 percentage Standard Error 1.080	1.79 percentage Standard Error 1.194	3.67 percentage Standard Error 1.112
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Baseline Ground Glass Opacity (% of whole lung field volume)	5.01 percentage Standard Error 0.357	4.91 percentage Standard Error 0.399	4.72 percentage Standard Error 0.367
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Week 24 Ground Glass Opacity (% of whole lung field volume)	4.77 percentage Standard Error 0.358	4.49 percentage Standard Error 0.400	4.52 percentage Standard Error 0.369
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Change from Baseline to Week 24 in Ground Glass Opacity (% of whole lung field volume)	-0.23 percentage Standard Error 0.177	-0.41 percentage Standard Error 0.195	-0.20 percentage Standard Error 0.182
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Week 24 Reticulation (% of whole lung field volume)	28.13 percentage Standard Error 2.001	24.97 percentage Standard Error 2.231	26.34 percentage Standard Error 2.062
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Change from Baseline to Week 24 in Reticulation (% of whole lung field volume)	0.67 percentage Standard Error 0.964	1.28 percentage Standard Error 1.069	2.32 percentage Standard Error 1.010
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Baseline Honeycombing (% of whole lung field volume)	4.54 percentage Standard Error 0.861	2.50 percentage Standard Error 0.961	1.54 percentage Standard Error 0.886
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Week 24 Honeycombing (% of whole lung field volume)	6.36 percentage Standard Error 1.018	3.11 percentage Standard Error 1.135	2.37 percentage Standard Error 1.047
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Change from Baseline to Week 24 in Honeycombing (% of whole lung field volume)	1.81 percentage Standard Error 0.542	0.61 percentage Standard Error 0.604	0.83 percentage Standard Error 0.558
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Baseline Normal Lung (% of whole lung field volume)	58.47 percentage Standard Error 2.281	64.52 percentage Standard Error 2.544	65.57 percentage Standard Error 2.343
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Week 24 Normal Lung (% of whole lung field volume)	56.42 percentage Standard Error 2.287	63.35 percentage Standard Error 2.549	62.68 percentage Standard Error 2.352
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Change from Baseline to Week 24 in Estimation of Normal Lung (% of whole lung field volume)	-2.05 percentage Standard Error 1.027	-1.17 percentage Standard Error 1.134	-2.88 percentage Standard Error 1.057
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Baseline Emphysema (% of whole lung field volume)	9.62 percentage Standard Error 1.640	10.66 percentage Standard Error 1.829	8.14 percentage Standard Error 1.684
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Week 24 Emphysema (% of whole lung field volume)	12.08 percentage Standard Error 1.646	9.54 percentage Standard Error 1.835	8.45 percentage Standard Error 1.694
Quantitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Change from Baseline to Week 24 in Estimation of Emphysema (% of whole lung field volume)	2.46 percentage Standard Error 0.936	-1.12 percentage Standard Error 1.034	0.31 percentage Standard Error 0.964

SECONDARY outcome

Timeframe: Baseline to Visit 14 (Day 169)

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization) with HRCT assessment at Visit 14/Early Termination

Changes of interstitial lung abnormalities as measured by high-resolution computed tomography (HRCT; ie, change in parenchymal feature \[Baseline to Visit 14 (Day 169)\]), as determined by qualitative assessment (central radiologist). The Likert scale values are included in the descriptions presented. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) with HRCT assessment at Visit 14/Early Termination is presented.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=30 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=34 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Much better (5)	0 Participants	0 Participants	0 Participants
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Better (4)	0 Participants	0 Participants	1 Participants
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Same (3)	28 Participants	26 Participants	28 Participants
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Worse (2)	6 Participants	3 Participants	3 Participants
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Much worse (1)	3 Participants	1 Participants	2 Participants
Qualitative Changes of Interstitial Lung Abnormalities as Measured by HRCT Unknown	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to study completion, up to Day 239

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Total number of events of participants who experienced idiopathic pulmonary fibrosis (IPF) exacerbation (ie, an unexplained worsening of dyspnea, evidence of hypoxemia as defined by worsened or severely impaired gas exchange, new radiographic alveolar infiltrates, and an absence of an alternative explanation such as infection, pulmonary embolism, pneumothorax, or heart failure) or death (weeks).

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Events of IPF Exacerbation or Death and Rate of First IPF Exacerbation	7 events	3 events	4 events

SECONDARY outcome

Timeframe: up to 12 weeks after the end of study treatment

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Events (participants who experienced hospitalization for respiratory ailments or died) for respiratory ailments are presented. The intent-to-treat population (any randomized participants with treatment assignment according to the planned randomization) is presented.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Events of Hospitalization for Respiratory Ailments or Death	5 events	3 events	3 events

SECONDARY outcome

Timeframe: up to 12 weeks after the end of study treatment

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Rate of mortality due to all causes is presented. Overall survival was defined as the time from start of study treatment to death due to any cause.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Total Events of Death Due to All Causes	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to 12 weeks after end of study treatment

Population: ITT Population (include any randomized participants with treatment assignment according to the planned randomization)

Events of deterioration of Idiopathic Pulmonary Fibrosis (IPF) resulting in lung transplantation (LP; up to 12 weeks after the end of study treatment) or death (weeks) and rate of deterioration of IPF resulting in lung transplantation (up to 12 weeks after the end of study treatment) are presented. Total events = Participants who experience deterioration of IPF resulting in LP (or died). Rate of Deterioration = Rate of Deterioration of IPF Resulting in LP.

Outcome measures

Outcome measures
Measure	Placebo n=42 Participants Intravenous placebo infusion every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 Participants ND-L02-s0201: 45 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 90 mg n=40 Participants ND-L02-s0201: 90 mg intravenous administration every 2 weeks (± 4 days for Visit 3 or ± 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation Total events to Deterioration of IPF Resulting in LP or Death:	3 events	1 events	0 events
Events of Deterioration of IPF Resulting in Lung Transplantation or Death and Rate of Deterioration of IPF Resulting in Lung Transplantation Rate of Deterioration of IPF Resulting in LP: Total Events	2 events	0 events	0 events

Adverse Events

Placebo

Serious events: 9 serious events

Other events: 35 other events

Deaths: 1 deaths

ND-L02-s0201 45 mg

Serious events: 4 serious events

Other events: 37 other events

Deaths: 1 deaths

ND-L02-s0201 90 mg

Serious events: 6 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Nitto Denko Corporation Study Director

Nitto Denko Corporation

Phone: 858-255-3010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Nitto Denko Corporation agreements with investigators vary; constant is Nitto's right to embargo communications regarding trial results prior to public release for a period \<30 days from submittal for review. Nitto will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=42 participants at risk Intravenous placebo infusion every 2 weeks (plus/minus 4 days for Visit 3 or plus/minus 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.	ND-L02-s0201 45 mg n=41 participants at risk ND-L02-s0201: 45 mg intravenous administration every 2 weeks (plus/minus 4 days for Visit 3 or plus/minus 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses	ND-L02-s0201 90 mg n=40 participants at risk ND-L02-s0201: 90 mg intravenous administration every 2 weeks (plus/minus 4 days for Visit 3 or plus/minus 7 days for Visits 4 to 13, ensuring a minimum of 7 days between each dose) for a total of 12 doses.
Nervous system disorders Cervical radiculopathy	2.4% 1/42 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Infections and infestations Influenza	2.4% 1/42 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	9.5% 4/42 • Number of events 5 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Infections and infestations COVID-19 pneumonia	2.4% 1/42 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	2.4% 1/42 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Anastomotic haemorrhage	2.4% 1/42 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Nervous system disorders Encephalopathy	2.4% 1/42 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Nervous system disorders Thalamic infarction	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
General disorders Vascular stent stenosis	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/41 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diverticulum	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	0.00% 0/40 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/42 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.4% 1/41 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.	2.5% 1/40 • Number of events 1 • Approximately 40 weeks (from screening to follow-up visit). Safety population includes all participants who received at least one dose of study treatment.