Idiopathic Pulmonary FibrosisPhase 2NCT05130970
Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
A Phase 2 study testing Garadacimab in people with Idiopathic Pulmonary Fibrosis, run by CSL Behring at 47 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Garadacimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 47 sitesin 11 countries
- Study dates
- 3 Feb 2022to 2 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥ 40 years of age
- Documented diagnosis of IPF
Who cannot join
- 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
Trial locations and contacts
47 sites in 11 countries.
47 sites in 11 countries
United States25 sites
The University of Alabama at Birmingham
Birmingham, Alabama, 35205
Meris Clinical Research
Brandon, Florida, 33511
University of Cincinnati
Cincinnati, Ohio, 45267
Elite Medical Research
Dallas, Texas, 75230
Southwest Family Medicine Associates
Dallas, Texas, 75235
Baylor Scott and White Health - Advanced Lung Disease Specialists
Dallas, Texas, 75246
Clinical Trial Center of Middle Tennesse
Franklin, Tennessee, 37067
Hannibal Clinic
Hannibal, Missouri, 63401
Baylor College of Medicine
Houston, Texas, 77030
National Institute of Clinical Research
Huntington Beach, California, 92647
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California - Center for Advanced Lung Disease
Los Angeles, California, 90033
Reliant Medical Research
Miami, Florida, 33165
US Associates in Research LLC
Miami, Florida, 33175
Lakes Research
Miami Lakes, Florida, 33014
Weill Cornell Medical Center
New York, New York, 10021
Renstar Medical Research
Ocala, Florida, 34471
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of California Irvine
Orange, California, 92868
Central Florida Pulmonary Group, PA
Orlando, Florida, 32803
Temple University TMS
Philadelphia, Pennsylvania, 19140
Pulmonary Associates Clinical Trials AZ
Phoenix, Arizona, 85032
Jadestone Clinical Research
Silver Spring, Maryland, 20904
Superior Clinical Research
Smithfield, North Carolina, 27577
Southeastern Research Center
Winston-Salem, North Carolina, 27103
Germany4 sites
Fachkrankenhaus Coswig GmbH
Coswig, 01640
Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)
Essen, 45239
Medizinische Hochschule Hannover - Klinik für Pneumologie
Hanover, 30625
Petrus Krankenhaus Wuppertal
Wuppertal, 42283
United Kingdom4 sites
Queen Elizabeth Hospital
Birmingham, B15 2GW
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Manchester Univ NHS - Wythenshawe Hospital
Manchester, M23 9LT
The Churchill Hospital - Oxford University Hospitals NHS Trust
Oxford, MD, OX3 7LE
Poland3 sites
Centrum Medycyny Oddechowej Bialymstoku
Bialystok, 15-044
Twoja Przychodnia Centrum Medyczne Nowa Sol
Nowa Sól, 67-100
Centrum Badań Klinicznych NZOZ
Wroclaw, 51-162
Austria2 sites
Medizinische Univerität Graz
Graz, 8036
Kepler Universitätsklinikum
Linz, 4021
Belgium2 sites
Universitair Ziekenhuis (UZ) Leuven
Leuven, 3000
Centre Hospitalier Universitaire Sart Tilman
Liège, 4000
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario, N8X 1T3
Spain2 sites
Giromed Institute, SLP
Barcelona, 08006
Hospital Universitario Puerta del Mar (HUPM)
Cadiz, 11009
Denmark1 site
Odense Universitetshospital - Lungemedicinsk Forskningsenhed
Odense, 5000
Italy1 site
Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia
Foggia, 71122
About this study
Official title: 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).
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Garadacimab, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaradacimabDrug
Also called Factor XIIa antagonist monoclonal antibody, CSL312
Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.
PlaceboDrug
Participants received a matching placebo IV loading dose, followed by 3 SC doses.
| Study group | Role | What they receive |
|---|---|---|
| Garadacimab | Experimental | Administered IV and SC Receives: Drug: Garadacimab |
| Placebo | Placebo comparator | Administered IV and SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs)
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.
Measured: Up to 22 weeks
Percentage of Participants With TE SAEs
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
Measured: Up to 22 weeks
Number of Participants With TE Adverse Events of Special Interests (AESIs)
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.
Measured: Up to 22 weeks
Percentage of Participants With TE-AESIs
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.
Measured: Up to 22 weeks
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma
Measured: At Day 36 and Day 92 after the first treatment
Percentage of Participants With Garadacimab Induced ADAs in Plasma
Measured: 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)
Measured: Up to 14 weeks after treatment
Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs
Measured: Up to 14 weeks after treatment
Secondary outcomes (9)
Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab
Measured: At Day 36 and Day 64
Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab
Measured: After dosing on Day 64
Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab
Measured: 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
Measured: After dosing on Day 64
Ctrough After IV Administration of Garadacimab
Measured: At Day 8
Cmax After IV Administration of Garadacimab
Measured: After dosing on Day 1
Tmax After IV Administration of Garadacimab
Measured: After dosing on Day 1
Mean Change From Baseline in FXIIa-mediated Kallikrein Activity
Measured: Baseline and at Day 92
Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity
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.
Measured: Baseline and at Day 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start3 Feb 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130970
- Sponsor's protocol ID
- CSL312_2002
- Other IDs
- 2021 003162 12
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2021
- Last updated
- 13 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Garadacimab in Subjects With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT05130970
- Acronym / sponsor ID
- CSL312_2002
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Posted 13 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garadacimab | Experimental | Drug: GaradacimabAdministered IV and SC |
| Placebo | Placebo comparator | Drug: PlaceboAdministered IV and SC |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients ≥ 40 years of age
- Documented diagnosis of IPF
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaradacimabAlso: Factor XIIa antagonist monoclonal antibody, CSL312Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses. | Drug | Garadacimab |
| PlaceboParticipants received a matching placebo IV loading dose, followed by 3 SC doses. | Drug | Placebo |
Primary outcome
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.
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
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.
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.
Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma
Time frame: 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
Number of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as Adverse Events (AEs)
Time frame: 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
9 secondary outcomes
Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab
Time frame: At Day 36 and Day 64
Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab
Time frame: 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
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
Ctrough After IV Administration of Garadacimab
Time frame: At Day 8
Cmax After IV Administration of Garadacimab
Time frame: After dosing on Day 1
Tmax After IV Administration of Garadacimab
Time frame: After dosing on Day 1
Mean Change From Baseline in FXIIa-mediated Kallikrein Activity
Time frame: Baseline and at Day 92
Mean Percentage of Baseline in FXIIa-mediated Kallikrein Activity
Time frame: Baseline and at Day 92
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSL Behring
47 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Garadacimab in people with Idiopathic Pulmonary Fibrosis, run by CSL Behring at 47 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Germany, United Kingdom, Poland, Austria and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-emergent (TE) Serious Adverse Events (SAEs) (time frame: Up to 22 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.