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CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05130970
Recruitment Status : Completed
First Posted : November 23, 2021
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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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 CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: CSL312 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : January 27, 2022
Actual Primary Completion Date : January 2, 2024
Actual Study Completion Date : January 2, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CSL312
Administered IV and SC
 Drug: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Other Names:
  • Factor XIIa antagonist monoclonal antibody
  • Garadacimab
Placebo Comparator: Placebo
Administered IV and SC
 Drug: Placebo
Same as the CSL312 formulation buffer


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
  2. Percent of participants with SAEs for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
  3. Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
  4. Percent of participants with AESIs for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
  5. Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs) [ Time Frame: Up to 14 weeks ]
  6. Percent of participants with CSL312 induced ADAs [ Time Frame: Up to 14 weeks ]
  7. Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo [ Time Frame: Up to 14 weeks ]
  8. Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo [ Time Frame: Up to 14 weeks ]

Secondary Outcome Measures :
  1. Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312 [ Time Frame: Up to 14 weeks ]
  2. Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
  3. Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
  4. Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
  5. Ctrough after intravenous (IV) administration of CSL312 [ Time Frame: Up to 8 days ]
  6. Cmax after IV administration of CSL312 [ Time Frame: Up to 8 days ]
  7. Tmax after IV administration of CSL312 [ Time Frame: Up to 8 days ]
  8. Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312 [ Time Frame: Up to 14 weeks ]
  9. Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312 [ Time Frame: Up to 14 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130970


Locations
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Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
More Information
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT05130970    
Other Study ID Numbers: CSL312_2002
2021 003162 12 ( EudraCT Number )
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases