Garadacimab for Idiopathic Pulmonary Fibrosis

No longer recruiting at 52 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called garadacimab (CSL312) for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. Researchers aim to determine the safety and effectiveness of this treatment in the body. Participants will receive either the experimental treatment or a placebo (a harmless, inactive substance) through injections. Individuals diagnosed with IPF and over 40 years old may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in IPF treatment.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that garadacimab, also known as CSL312, has been tested for conditions like hereditary angioedema. In these studies, garadacimab proved generally safe, with most patients handling the treatment well over time. Specifically, one study found that 57.3% of patients taking garadacimab experienced no attacks over about 1.2 years, indicating that the treatment is usually well-tolerated. While these findings pertain to hereditary angioedema, they offer insight into the potential safety of garadacimab for other conditions, such as idiopathic pulmonary fibrosis. As this trial begins, it will continue to gather more safety data. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IPF?

Researchers are excited about Garadacimab for idiopathic pulmonary fibrosis (IPF) because it offers a unique approach compared to existing treatments like nintedanib and pirfenidone, which mainly focus on slowing disease progression. Garadacimab is different because it targets the Factor XIIa pathway, which plays a role in inflammation and fibrosis, potentially addressing the disease's underlying mechanisms. Additionally, it is administered both intravenously and subcutaneously, providing flexibility in how patients can receive the treatment. This novel mechanism and flexible delivery method could lead to improved outcomes for those living with IPF.

What evidence suggests that garadacimab might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that garadacimab, also known as CSL312, offers potential benefits for various conditions. In studies on hereditary angioedema (HAE), garadacimab significantly reduced the number of attacks compared to a placebo. This trial will evaluate garadacimab's effects on idiopathic pulmonary fibrosis (IPF), where it might help manage the condition by reducing lung inflammation through its mechanism of blocking factor XIIa, a protein involved in inflammation. Although specific data for IPF are limited, its mechanism suggests potential benefits. Early studies in other conditions have demonstrated improvements in patients' quality of life, offering hope for those considering this treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

CSL Behring

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. jacionline.org jacionline.org/article/S0091-6749(24)01894-3/fulltext

Garadacimab Real-World Treatment Outcomes Of ... The GREAT study will gather the first real-word data on effectiveness, safety, HRQoL, and HCRU in patients with HAE receiving garadacimab LTP in routine ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38710185/

Garadacimab for hereditary angioedema attack prevention Here, we assessed the impact of garadacimab on patient-reported and investigator-reported outcomes and HRQoL as well as long-term efficacy and ...

3. medicalaffairs.cslbehring.com medicalaffairs.cslbehring.com/-/media/medical-affairs/documents/posters/hae/hae_garadacimab-great-study-design_poster_100094_csl-medical-affairs.pdf

CONCLUSIONS - CSL Behring Medical Affairs Garadacimab Real-World Treatment Outcomes of Effectiveness, Safety, and Quality-Of-Life in Patients. With HAE (GREAT) Study Design. Marc A Riedl1, Laurence ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04739059

NCT04739059 | Long-term Safety and Efficacy of CSL312 ... An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema. Conditions.

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(23)00350-1/abstract

Efficacy and safety of garadacimab, a factor XIIa inhibitor ... Monthly garadacimab administration significantly reduced hereditary angioedema attacks in patients aged 12 years and older compared with placebo and had a ...

6. medicalaffairs.cslbehring.com medicalaffairs.cslbehring.com/-/media/medical-affairs/documents/posters/garadacimab/garadacimab_integrated-safety-and-efficacy_slide-deck_csl-medical-affairs.pdf

Integrated safety and efficacy of garadacimab for hereditary ... Integrated safety analysis set: Long-term safety data. Data cut-off: Feb 13, 2023. *Newly enrolled patients received one 400 mg SC loading dose as their ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352302624000814

Garadacimab for hereditary angioedema attack prevention ... In this Article, we report the long-term efficacy and safety data for garadacimab for the prevention of attacks in patients with hereditary angioedema with C1- ...

8. jacionline.org jacionline.org/article/S0091-6749(23)02309-6/fulltext

Integrated Safety And Efficacy Of Garadacimab For ... Over a median 1.2 years' observation, the majority of garadacimab-treated patients (94/164, 57.3%) remained attack-free. No placebo-receiving patients (n=25) ...