Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Garadacimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05130970

CSL312_2002

2021 003162 12 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 81 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Garadacimab

Experimental group

Description:

Administered IV and SC

Treatment:

Drug: Garadacimab

Placebo

Placebo Comparator group

Description:

Administered IV and SC

Treatment:

Drug: Placebo