Clinical trial NCT05130970: Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
Official title: A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2021-11-23
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)
timeFrame: Up to 22 weeks
measure: Percentage of Participants With TE SAEs
timeFrame: Up to 22 weeks
measure: Number of Participants With TE Adverse Events of Special Interests (AESIs)
timeFrame: Up to 22 weeks
measure: Percentage of Participants With TE-AESIs
timeFrame: Up to 22 weeks
measure: Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma
timeFrame: At Day 36 and Day 92 after the first treatment
measure: Percentage of Participants With Garadacimab Induced ADAs in Plasma
timeFrame: At Day 36 and Day 92 after the first treatment
measure: Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)
timeFrame: Up to 14 weeks after treatment
measure: Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs
timeFrame: Up to 14 weeks after treatment
Secondary outcomes:
measure: Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab
timeFrame: At Day 36 and Day 64
measure: Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab
timeFrame: After dosing on Day 64
measure: Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab
timeFrame: After dosing on Day 64
measure: Area Under the Plasma Concentration-time Curve Over the Dose Interval (AUC0-tau) (Last SC Dosing Interval Only) of Garadacimab
timeFrame: After dosing on Day 64
measure: Ctrough After IV Administration of Garadacimab
timeFrame: At Day 8
measure: Cmax After IV Administration of Garadacimab
timeFrame: After dosing on Day 1
measure: Tmax After IV Administration of Garadacimab
timeFrame: After dosing on Day 1
measure: Mean Change From Baseline in FXIIa-mediated Kallikrein Activity
timeFrame: Baseline and at Day 92
measure: Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity
timeFrame: Baseline and at Day 92
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Pulmonary Associates Clinical Trials AZ
state: Arizona
city: Huntington Beach
country: United States
facility: National Institute of Clinical Research
state: California
city: Los Angeles
country: United States
facility: University of Southern California - Center for Advanced Lung Disease
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Miami Lakes
country: United States
facility: Lakes Research
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Miami
country: United States
facility: US Associates in Research LLC
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group, PA
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Silver Spring
country: United States
facility: Jadestone Clinical Research
state: Maryland
city: Hannibal
country: United States
facility: Hannibal Clinic
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Smithfield
country: United States
facility: Superior Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University TMS
state: Pennsylvania
city: Franklin
country: United States
facility: Clinical Trial Center of Middle Tennesse
state: Tennessee
city: Dallas
country: United States
facility: Elite Medical Research
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Dallas
country: United States
facility: Baylor Scott and White Health - Advanced Lung Disease Specialists
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Graz
country: Austria
facility: Medizinische Univerität Graz
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis (UZ) Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Sart Tilman
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Professional Corporation
state: Ontario
city: Odense
country: Denmark
facility: Odense Universitetshospital - Lungemedicinsk Forskningsenhed
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig GmbH
city: Essen
country: Germany
facility: Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover - Klinik für Pneumologie
city: Wuppertal
country: Germany
facility: Petrus Krankenhaus Wuppertal
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
city: Białystok
country: Poland
facility: Centrum Medycyny Oddechowej Bialymstoku
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia Centrum Medyczne Nowa Sol
city: Wrocław
country: Poland
facility: Centrum Badań Klinicznych NZOZ
city: Barcelona
country: Spain
facility: Giromed Institute, SLP
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar (HUPM)
city: Oxford
country: United Kingdom
facility: The Churchill Hospital - Oxford University Hospitals NHS Trust
state: MD
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Londonderry
country: United Kingdom
facility: Altnagelvin Area Hospital
city: Manchester
country: United Kingdom
facility: Manchester Univ NHS - Wythenshawe Hospital
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: