Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT05130970
- Lead Sponsor
- CSL Behring
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- Male or female patients ≥ 40 years of age
- Documented diagnosis of IPF
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Administered IV and SC Garadacimab Garadacimab Administered IV and SC
- Primary Outcome Measures
Name Time Method Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma At Day 36 and Day 92 after the first treatment Percentage of Participants With Garadacimab Induced ADAs in Plasma At Day 36 and Day 92 after the first treatment Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs) 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.
Percentage of Participants With TE SAEs 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
Number of Participants With TE Adverse Events of Special Interests (AESIs) 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.
Percentage of Participants With TE-AESIs 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.
Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs) Up to 14 weeks after treatment Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs Up to 14 weeks after treatment
- Secondary Outcome Measures
Name Time Method Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab At Day 36 and Day 64 Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab After dosing on Day 64 Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab After dosing on Day 64 Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab After dosing on Day 64 Ctrough After IV Administration of Garadacimab At Day 8 Cmax After IV Administration of Garadacimab After dosing on Day 1 Tmax After IV Administration of Garadacimab After dosing on Day 1 Mean Change From Baseline in FXIIa-mediated Kallikrein Activity Baseline and at Day 92 Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity 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.
Trial Locations
- Locations (47)
Central Florida Pulmonary Group, PA
🇺🇸Orlando, Florida, United States
Hospital Universitario Puerta del Mar (HUPM)
🇪🇸Cadiz, Spain
Kepler Universitätsklinikum
🇦🇹Linz, Austria
Centrum Badań Klinicznych NZOZ
🇵🇱Wrocław, Poland
Twoja Przychodnia Centrum Medyczne Nowa Sol
🇵🇱Nowa Sol, Poland
The Churchill Hospital - Oxford University Hospitals NHS Trust
🇬🇧Oxford, MD, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Giromed Institute, SLP
🇪🇸Barcelona, Spain
Elite Medical Research
🇺🇸Dallas, Texas, United States
Lakes Research
🇺🇸Miami Lakes, Florida, United States
Baylor Scott and White Health - Advanced Lung Disease Specialists
🇺🇸Dallas, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Medizinische Univerität Graz
🇦🇹Graz, Austria
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Odense Universitetshospital - Lungemedicinsk Forskningsenhed
🇩🇰Odense, Denmark
Altnagelvin Area Hospital
🇬🇧Londonderry, United Kingdom
National Institute of Clinical Research
🇺🇸Huntington Beach, California, United States
Pulmonary Associates Clinical Trials AZ
🇺🇸Phoenix, Arizona, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Meris Clinical Research
🇺🇸Brandon, Florida, United States
US Associates in Research LLC
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Hannibal Clinic
🇺🇸Hannibal, Missouri, United States
Jadestone Clinical Research
🇺🇸Silver Spring, Maryland, United States
Temple University TMS
🇺🇸Philadelphia, Pennsylvania, 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
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Universitair Ziekenhuis (UZ) Leuven
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire Sart Tilman
🇧🇪Liège, Belgium
Dr. Syed Anees Medicine Professional Corporation
🇨🇦Windsor, Ontario, Canada
Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
🇩🇪Essen, Germany
Fachkrankenhaus Coswig GmbH
🇩🇪Coswig, Germany
Medizinische Hochschule Hannover - Klinik für Pneumologie
🇩🇪Hannover, Germany
Petrus Krankenhaus Wuppertal
🇩🇪Wuppertal, Germany
Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
🇮🇹Foggia, Italy
Centrum Medycyny Oddechowej Bialymstoku
🇵🇱Białystok, Poland
Manchester Univ NHS - Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Clinical Trial Center of Middle Tennesse
🇺🇸Franklin, Tennessee, United States
University of Southern California - Center for Advanced Lung Disease
🇺🇸Los Angeles, California, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of California Irvine
🇺🇸Orange, California, United States
Reliant Medical Research
🇺🇸Miami, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada