Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

November 20, 2024 updated by: CSL Behring

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Univerität Graz
      • Linz, Austria, 4021
        • Kepler Universitätsklinikum
  • Belgium
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis (UZ) Leuven
      • Liège, Belgium, 4000
        • Centre Hospitalier Universitaire Sart Tilman
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Windsor, Ontario, Canada, N8X 1T3
        • Dr. Syed Anees Medicine Professional Corporation
  • Denmark
      • Odense, Denmark, 5000
        • Odense Universitetshospital - Lungemedicinsk Forskningsenhed
  • Germany
      • Coswig, Germany, 01640
        • Fachkrankenhaus Coswig GmbH
      • Essen, Germany, 45239
        • Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover - Klinik für Pneumologie
      • Wuppertal, Germany, 42283
        • Petrus Krankenhaus Wuppertal
  • Italy
      • Foggia, Italy, 71122
        • Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
  • Poland
      • Białystok, Poland, 15-044
        • Centrum Medycyny Oddechowej Bialymstoku
      • Nowa Sol, Poland, 67-100
        • Twoja Przychodnia Centrum Medyczne Nowa Sol
      • Wrocław, Poland, 51-162
        • Centrum Badań Klinicznych NZOZ
  • Spain
      • Barcelona, Spain, 08006
        • Giromed Institute, SLP
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta del Mar (HUPM)
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Queen Elizabeth Hospital
      • Londonderry, United Kingdom, BT47 6SB
        • Altnagelvin Area Hospital
      • Manchester, United Kingdom, M23 9LT
        • Manchester Univ NHS - Wythenshawe Hospital
    • MD
      • Oxford, MD, United Kingdom, OX3 7LE
        • The Churchill Hospital - Oxford University Hospitals NHS Trust
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • The University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pulmonary Associates Clinical Trials AZ
    • California
      • Huntington Beach, California, United States, 92647
        • National Institute of Clinical Research
      • Los Angeles, California, United States, 90033
        • University of Southern California - Center for Advanced Lung Disease
      • Orange, California, United States, 92868
        • University of California Irvine
    • Florida
      • Brandon, Florida, United States, 33511
        • Meris Clinical Research
      • Miami, Florida, United States, 33165
        • Reliant Medical Research
      • Miami, Florida, United States, 33175
        • US Associates in Research LLC
      • Miami Lakes, Florida, United States, 33014
        • Lakes Research
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group, PA
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Maryland
      • Silver Spring, Maryland, United States, 20904
        • Jadestone Clinical Research
    • Missouri
      • Hannibal, Missouri, United States, 63401
        • Hannibal Clinic
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
    • North Carolina
      • Smithfield, North Carolina, United States, 27577
        • Superior Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Southeastern Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University TMS
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Clinical Trial Center of Middle Tennesse
    • Texas
      • Dallas, Texas, United States, 75235
        • Southwest Family Medicine Associates
      • Dallas, Texas, United States, 75230
        • Elite Medical Research
      • Dallas, Texas, United States, 75246
        • Baylor Scott and White Health - Advanced Lung Disease Specialists
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Administered IV and SC
Drug: Placebo
Participants received a matching placebo IV loading dose, followed by 3 SC doses.
Experimental: Garadacimab
Administered IV and SC
Drug: Garadacimab
Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • CSL312

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 22 weeks
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
Up to 22 weeks
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.
Up to 22 weeks
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.
Up to 22 weeks
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma
Time Frame: At Day 36 and Day 92 after the first treatment
At Day 36 and Day 92 after the first treatment
Percentage of Participants With Garadacimab Induced ADAs in Plasma
Time Frame: At Day 36 and Day 92 after the first treatment
At Day 36 and Day 92 after the first treatment
Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)
Time Frame: Up to 14 weeks after treatment
Up to 14 weeks after treatment
Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs
Time Frame: Up to 14 weeks after treatment
Up to 14 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab
Time Frame: At Day 36 and Day 64
At Day 36 and Day 64
Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab
Time Frame: After dosing on Day 64
After dosing on Day 64
Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab
Time Frame: After dosing on Day 64
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
Time Frame: After dosing on Day 64
After dosing on Day 64
Ctrough After IV Administration of Garadacimab
Time Frame: At Day 8
At Day 8
Cmax After IV Administration of Garadacimab
Time Frame: After dosing on Day 1
After dosing on Day 1
Tmax After IV Administration of Garadacimab
Time Frame: After dosing on Day 1
After dosing on Day 1
Mean Change From Baseline in FXIIa-mediated Kallikrein Activity
Time Frame: Baseline and at Day 92
Baseline and at Day 92
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.
Baseline and at Day 92

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CSL Behring

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, CSL Behring

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSL312_2002
  • 2021 003162 12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

IPD Sharing Time Frame

IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.

IPD Sharing Access Criteria

Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.

An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.

The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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