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Completed

NCT Number: NCT05130970

Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

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).

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garadacimab

Drug

Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.

Other names: Factor XIIa antagonist monoclonal antibody, CSL312

Placebo

Drug

Participants received a matching placebo IV loading dose, followed by 3 SC doses.

Primary outcomes

  1. Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)

    Time frame: Up to 22 weeks

    A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event.

  2. Percentage of Participants With TE SAEs

    Time frame: Up to 22 weeks

    A TE SAE is defined as an SAE reported at or after the start of the first administration of study treatment. A SAE is defined as any untoward medical occurrence that at any dose results in: death, life-threatening event, initial or prolongation of existing hospitalization, disability or incapacity, congenital anomaly or birth defect, or any other medically significant event

  3. Number of Participants With TE Adverse Events of Special Interests (AESIs)

    Time frame: Up to 22 weeks

    The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis [e.g., localized thrombosis associated with vascular access] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.

  4. Percentage of Participants With TE-AESIs

    Time frame: Up to 22 weeks

    The following TEAEs were considered as AESIs: Bleeding events that were abnormal in the opinion of the Investigator, Thromboembolic events (non-systemic thrombosis [e.g., localized thrombosis associated with vascular access] was not considered an AESI), and Severe hypersensitivity including anaphylaxis.

  5. Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma

    Time frame: At Day 36 and Day 92 after the first treatment

  6. Percentage of Participants With Garadacimab Induced ADAs in Plasma

    Time frame: At Day 36 and Day 92 after the first treatment

  7. Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)

    Time frame: Up to 14 weeks after treatment

  8. Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs

    Time frame: Up to 14 weeks after treatment

Secondary outcomes

  1. Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab

    Time frame: At Day 36 and Day 64

  2. Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab

    Time frame: After dosing on Day 64

  3. Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab

    Time frame: After dosing on Day 64

  4. Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab

    Time frame: After dosing on Day 64

  5. Ctrough After IV Administration of Garadacimab

    Time frame: At Day 8

  6. Cmax After IV Administration of Garadacimab

    Time frame: After dosing on Day 1

  7. Tmax After IV Administration of Garadacimab

    Time frame: After dosing on Day 1

  8. Mean Change From Baseline in FXIIa-mediated Kallikrein Activity

    Time frame: Baseline and at Day 92

  9. Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity

    Time frame: Baseline and at Day 92

    Percent baseline is calculated by using the formula visit value / baseline value multiplied by 100, percent baseline is reported as percentage in the outcome measure.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 23, 2021
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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