Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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).

Key facts

Study ID

NCT05130970

Run by

CSL Behring

People needed

81

Starts

2022-02-03

Expected to finish

2024-01-02

Last updated by the study team

2024-12-13

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients ≥ 40 years of age
• Documented diagnosis of IPF

You may not qualify if…

• 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

Where it is running

• Kepler Universitätsklinikum — Linz, Austria
• Royal Adelaide Hospital — Adelaide, Australia
• 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
• Reliant Medical Research — Miami, Florida, United States
• US Associates in Research LLC — Miami, Florida, United States
• Lakes Research — Miami Lakes, Florida, United States
• Renstar Medical Research — Ocala, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Jadestone Clinical Research — Silver Spring, Maryland, United States
• Hannibal Clinic — Hannibal, Missouri, United States
• Weill Cornell Medical Center — New York, New York, United States
• Superior Clinical Research — Smithfield, North Carolina, United States
• Southeastern Research Center — Winston-Salem, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Temple University TMS — Philadelphia, Pennsylvania, United States
• Clinical Trial Center of Middle Tennesse — Franklin, Tennessee, United States
• Elite Medical Research — Dallas, Texas, United States
• Southwest Family Medicine Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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