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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Garadacimab 		Administered IV and SC
  • Drug: Garadacimab
    Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.
    Other names:
    • Factor XIIa antagonist monoclonal antibody
    • CSL312
Placebo Comparator
Placebo 		Administered IV and SC
  • Drug: Placebo
    Participants received a matching placebo IV loading dose, followed by 3 SC doses.

Recruiting Locations

More Details

NCT ID
NCT05130970
Status
Completed
Sponsor
CSL Behring

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center