Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Phase 2

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Placebo; Drug: Garadacimab

• Registration Number: NCT05130970
• Lead Sponsor: CSL Behring

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-23
• Study Start: 2022-02-03
• Primary Completion: 2024-01-02
• Study Completion: 2024-01-02
• Status Verified: 2024-11
• Results First Submitted: 2024-11-20
• Results First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Results First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administered IV and SC
Garadacimab	Garadacimab	Administered IV and SC

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)	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	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)	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	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	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)	Up to 14 weeks after treatment
Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs	Up to 14 weeks after treatment
Percentage of Participants With Garadacimab Induced ADAs in Plasma	At Day 36 and Day 92 after the first treatment

Secondary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (47)

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Pulmonary Associates Clinical Trials AZ; 🇺🇸 Phoenix, Arizona, United States

National Institute of Clinical Research; 🇺🇸 Huntington Beach, California, United States

University of Southern California - Center for Advanced Lung Disease; 🇺🇸 Los Angeles, California, United States

University of California Irvine; 🇺🇸 Orange, California, United States

Meris Clinical Research; 🇺🇸 Brandon, Florida, United States

Lakes Research; 🇺🇸 Miami Lakes, Florida, United States

Reliant Medical Research; 🇺🇸 Miami, Florida, United States

US Associates in Research LLC; 🇺🇸 Miami, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, Florida, United States

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