Phase 2 Completed N=81 Randomized Quadruple-blind Treatment

Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Source: ClinicalTrials.gov NCT05130970 ↗

Enrolled (actual)

Serious AEs

8.6%

Results posted

Dec 2024

Primary outcomePrimary: Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs) — 5; 2 Participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)	5; 2	—
PRIMARY Percentage of Participants With TE SAEs	12.5; 4.9	—
PRIMARY Number of Participants With TE Adverse Events of Special Interests (AESIs)	2; 0	—
PRIMARY Percentage of Participants With TE-AESIs	5.0; 0	—
PRIMARY Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma	1; 2; 1; 1	—
PRIMARY Percentage of Participants With Garadacimab Induced ADAs in Plasma	2.6; 5.4; 2.6; 2.8	—
PRIMARY Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)	0; 0	—
PRIMARY Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs	0.0; 0.0	—
SECONDARY Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab	16.445; 17.123	—
SECONDARY Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab	37.41	—
SECONDARY Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab	165.4585	—
SECONDARY Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab	18094.6128	—
SECONDARY Ctrough After IV Administration of Garadacimab	18.6054	—
SECONDARY Cmax After IV Administration of Garadacimab	79.636	—
SECONDARY Tmax After IV Administration of Garadacimab	0.1000	—
SECONDARY Mean Change From Baseline in FXIIa-mediated Kallikrein Activity	-0.0258; 0.0072	—
SECONDARY Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity	129.56; 124.83	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05130970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.