A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- CSL Behring
- Enrollment
- 81
- Locations
- 47
- Primary Endpoint
- Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients ≥ 40 years of age
- •Documented diagnosis of IPF
Exclusion Criteria
- •History of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina during the 6 months before screening
- •Sinoatrial or atrioventricular block, uncontrolled hypertension
- •Active bleeding or current clinically significant coagulopathy
Arms & Interventions
Placebo
Administered IV and SC
Intervention: Placebo
Garadacimab
Administered IV and SC
Intervention: Garadacimab
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)
Time Frame: Up to 22 weeks
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.
Percentage of Participants With TE SAEs
Time Frame: Up to 22 weeks
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
Number of Participants With TE Adverse Events of Special Interests (AESIs)
Time Frame: Up to 22 weeks
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.
Percentage of Participants With TE-AESIs
Time Frame: Up to 22 weeks
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.
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma
Time Frame: At Day 36 and Day 92 after the first treatment
Percentage of Participants With Garadacimab Induced ADAs in Plasma
Time Frame: At Day 36 and Day 92 after the first treatment
Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)
Time Frame: Up to 14 weeks after treatment
Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs
Time Frame: Up to 14 weeks after treatment
Secondary Outcomes
- Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab(At Day 36 and Day 64)
- Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab(After dosing on Day 64)
- Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab(After dosing on Day 64)
- Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab(After dosing on Day 64)
- Ctrough After IV Administration of Garadacimab(At Day 8)
- Cmax After IV Administration of Garadacimab(After dosing on Day 1)
- Tmax After IV Administration of Garadacimab(After dosing on Day 1)
- Mean Change From Baseline in FXIIa-mediated Kallikrein Activity(Baseline and at Day 92)
- Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity(Baseline and at Day 92)