Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Recruiting at 48 trial locations

Overseen By Trial Registration Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CSL Behring

Disqualifiers: Cardiovascular disease, Hypertension, Coagulopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 22 weeks

81 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called CSL312 in patients with a lung disease called idiopathic pulmonary fibrosis (IPF). The goal is to see if the drug is safe, how it moves through the body, and if it can help reduce lung scarring.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Study Director

Principal Investigator

CSL Behring

Eligibility Criteria

This trial is for men and women over 40 with a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF). It's not suitable for those who've had significant heart disease, uncontrolled blood pressure, recent bleeding issues or clotting disorders.

Inclusion Criteria

Documented diagnosis of IPF

You are male or female and are 40 years of age or older.

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

Active bleeding or current clinically significant coagulopathy

You have a problem with your heart's electrical signals or high blood pressure that is not under control.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive garadacimab or placebo administered IV and SC to assess safety, pharmacokinetics, and pharmacodynamics

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CSL312

Trial Overview The study is testing CSL312 against a placebo to see its effects on IPF. Participants will be randomly assigned to either the drug or placebo group in a double-blind manner, meaning neither they nor the researchers know who gets what.

Participant Groups

Group I: Garadacimab Experimental Treatment 1 Intervention

Administered IV and SC

Group II: Placebo Placebo Group 1 Intervention

Administered IV and SC

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials

204

Recruited

1,207,000+

Dr. Paul McKenzie

CSL Behring

Chief Executive Officer since 2023

PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania

Dr. Bill Mezzanotte

CSL Behring

Chief Medical Officer since 2021

MD from Duke University