Trial Outcomes & Findings for Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis (NCT NCT05130970)

Last Updated: 2024-12-13

Results Overview

A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Up to 22 weeks

Results posted on

2024-12-13

Participant Flow

This study was conducted at 47 study sites in 11 countries (Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Poland, Spain, the United Kingdom \[UK\], and the United States of America \[USA\]). No participants from Italy were enrolled in the study.

A total of 131 potential participants were screened for eligibility. Out of these, 81 participants met all selection criteria and were enrolled in the study, and 50 individuals failed to meet the selection criteria and were not enrolled in the study.

Participant milestones

Participant milestones
Measure	Garadacimab Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Overall Study STARTED	40	41
Overall Study COMPLETED	38	36
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Garadacimab Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Overall Study Adverse Event	1	1
Overall Study Death	0	1
Overall Study Lost to Follow-up	0	1
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.	Total n=81 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Age, Continuous	72.6 years STANDARD_DEVIATION 6.19 • n=5 Participants	72.9 years STANDARD_DEVIATION 6.17 • n=7 Participants	72.8 years STANDARD_DEVIATION 6.14 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	21 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	20 Participants n=7 Participants	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants	39 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Austria	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Poland	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Denmark	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United Kingdom	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment Australia	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Germany	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Spain	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 22 weeks

Population: This analysis was performed on the safety analysis set (SAS). The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

Outcome measures

Outcome measures
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to 22 weeks

Population: This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

Outcome measures

Outcome measures
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Percentage of Participants With TE SAEs	12.5 Percentage of participants	4.9 Percentage of participants

PRIMARY outcome

Timeframe: Up to 22 weeks

Population: This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis \[e.g., localized thrombosis associated with vascular access\] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.

Outcome measures

Outcome measures
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Number of Participants With TE Adverse Events of Special Interests (AESIs)	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 22 weeks

Population: This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

Outcome measures

Outcome measures
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Percentage of Participants With TE-AESIs	5.0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: At Day 36 and Day 92 after the first treatment

Population: This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified timepoint.

Outcome measures

Outcome measures
Measure	Garadacimab n=39 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=37 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma At Day 36	1 Participants	2 Participants
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma At Day 92	1 Participants	1 Participants

PRIMARY outcome

Timeframe: At Day 36 and Day 92 after the first treatment

Outcome measures

Outcome measures
Measure	Garadacimab n=39 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=37 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Percentage of Participants With Garadacimab Induced ADAs in Plasma At Day 36	2.6 Percentage of participants	5.4 Percentage of participants
Percentage of Participants With Garadacimab Induced ADAs in Plasma At Day 92	2.6 Percentage of participants	2.8 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 weeks after treatment

Population: This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

Outcome measures

Outcome measures
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 14 weeks after treatment

Population: This analysis was performed on the SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

Outcome measures

Outcome measures
Measure	Garadacimab n=40 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: At Day 36 and Day 64

Population: This analysis was performed on pharmacokinetic analysis set (PKS). The PKS was defined as all participants in the SAS who received \>= 1 dose of garadacimab with \>= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure and the Number Analyzed (n), included all participants who were evaluated for this outcome measure for the specified timepoint.

Outcome measures

Outcome measures
Measure	Garadacimab n=37 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab At Day 36	16.445 Microgram/milliliter (ug/mL) Standard Deviation 6.0362	—
Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab At Day 64	17.123 Microgram/milliliter (ug/mL) Standard Deviation 7.9383	—

SECONDARY outcome

Timeframe: After dosing on Day 64

Population: This analysis was performed on PKS. The PKS was defined as all participants in the SAS who received \>= 1 dose of garadacimab with \>= 1 measurable concentration of garadacimab after administration. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure.

Outcome measures

Outcome measures
Measure	Garadacimab n=38 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab	37.41 ug/mL Standard Deviation 15.507	—

SECONDARY outcome

Timeframe: After dosing on Day 64

Outcome measures

Outcome measures
Measure	Garadacimab n=38 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab	165.4585 Hours (h) Interval 45.25 to 478.633	—

SECONDARY outcome

Timeframe: After dosing on Day 64

Outcome measures

Outcome measures
Measure	Garadacimab n=29 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab	18094.6128 h*ug/mL Standard Deviation 6977.9036	—

SECONDARY outcome

Timeframe: At Day 8

Outcome measures

Outcome measures
Measure	Garadacimab n=36 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Ctrough After IV Administration of Garadacimab	18.6054 ug/mL Standard Deviation 7.9685	—

SECONDARY outcome

Timeframe: After dosing on Day 1

Outcome measures

Outcome measures
Measure	Garadacimab n=37 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Cmax After IV Administration of Garadacimab	79.636 ug/mL Standard Deviation 31.4406	—

SECONDARY outcome

Timeframe: After dosing on Day 1

Outcome measures

Outcome measures
Measure	Garadacimab n=39 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Tmax After IV Administration of Garadacimab	0.1000 h Interval 0.017 to 0.967	—

SECONDARY outcome

Timeframe: Baseline and at Day 92

Population: This analysis was performed on pharmacodynamic analysis set (PDS). The PDS was defined as all participants in the SAS for whom analysis results were obtained for \>= 1 of the exploratory biomarkers of interest. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure.

Outcome measures

Outcome measures
Measure	Garadacimab n=32 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=32 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Mean Change From Baseline in FXIIa-mediated Kallikrein Activity	-0.0258 Nanomoles/liter/minutes (nmol/L/mins) Standard Deviation 0.0657	0.0072 Nanomoles/liter/minutes (nmol/L/mins) Standard Deviation 0.0706

SECONDARY outcome

Timeframe: Baseline and at Day 92

Population: This analysis was performed on PDS. The PDS was defined as all participants in the SAS for whom analysis results were obtained for \>= 1 of the exploratory biomarkers of interest. Here, the Overall Number of Participants Analyzed (N) included all participants who were evaluated for this outcome measure.

Percent baseline is calculated by using the formula visit value / baseline value multiplied by 100, percent baseline is reported as percentage in the outcome measure.

Outcome measures

Outcome measures
Measure	Garadacimab n=32 Participants Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=32 Participants Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity	129.56 Percent baseline Standard Deviation 215.689	124.83 Percent baseline Standard Deviation 68.872

Adverse Events

Garadacimab

Serious events: 5 serious events

Other events: 18 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Garadacimab n=40 participants at risk Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 participants at risk Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	7.5% 3/40 • Number of events 3 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	0.00% 0/41 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Gastrointestinal disorders Pancreatitis acute	2.5% 1/40 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	0.00% 0/41 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Infections and infestations Pneumonia	2.5% 1/40 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	0.00% 0/41 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/40 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/40 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Infections and infestations COVID-19	0.00% 0/40 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.

Other adverse events

Additional Information

Trial Registration Coordinator

CSL Behring LLC

Phone: 610 878 4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Garadacimab n=40 participants at risk Participants received garadacimab IV loading dose followed by 3 SC doses.	Placebo n=41 participants at risk Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Gastrointestinal disorders Abdominal discomfort	5.0% 2/40 • Number of events 3 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	0.00% 0/41 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Gastrointestinal disorders Diarrhoea	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	12.2% 5/41 • Number of events 8 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
General disorders Fatigue	7.5% 3/40 • Number of events 4 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	7.3% 3/41 • Number of events 4 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
General disorders Non-cardiac chest pain	5.0% 2/40 • Number of events 3 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Infections and infestations Bronchitis	7.5% 3/40 • Number of events 4 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	4.9% 2/41 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Infections and infestations COVID-19	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	4.9% 2/41 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Infections and infestations Urinary tract infection	7.5% 3/40 • Number of events 4 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Investigations C-reactive protein increased	2.5% 1/40 • Number of events 3 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	7.3% 3/41 • Number of events 3 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Musculoskeletal and connective tissue disorders Back pain	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	0.00% 0/41 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Nervous system disorders Dizziness	5.0% 2/40 • Number of events 3 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	9.8% 4/41 • Number of events 6 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Nervous system disorders Headache	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Nervous system disorders Presyncope	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	0.00% 0/41 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Respiratory, thoracic and mediastinal disorders Cough	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	12.2% 5/41 • Number of events 5 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.5% 1/40 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	9.8% 4/41 • Number of events 6 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	5.0% 2/40 • Number of events 2 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.	2.4% 1/41 • Number of events 1 • Up to 22 weeks This analysis was performed on SAS. The SAS was defined as all participants who received any portion of an IV infusion or SC injection of garadacimab or placebo.