CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

• ClinicalTrials.gov Identifier: NCT05130970
• Recruitment Status: Completed
• First Posted: November 23, 2021
• Last Update Posted: February 9, 2024
• Sponsor: CSL Behring
• Information provided by (Responsible Party): CSL Behring

Tracking Information

• First Submitted Date: November 12, 2021
• First Posted Date: November 23, 2021
• Last Update Posted Date: February 9, 2024
• Actual Study Start Date: January 27, 2022
• Actual Primary Completion Date: January 2, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 12, 2021)

• Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
• Percent of participants with SAEs for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
• Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
• Percent of participants with AESIs for CSL312 or placebo [ Time Frame: Up to 22 weeks ]
• Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs) [ Time Frame: Up to 14 weeks ]
• Percent of participants with CSL312 induced ADAs [ Time Frame: Up to 14 weeks ]
• 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 ]
• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 12, 2021)

• Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312 [ Time Frame: Up to 14 weeks ]
• Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
• Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312 [ Time Frame: Up to 14 weeks ]
• 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 ]
• Ctrough after intravenous (IV) administration of CSL312 [ Time Frame: Up to 8 days ]
• Cmax after IV administration of CSL312 [ Time Frame: Up to 8 days ]
• Tmax after IV administration of CSL312 [ Time Frame: Up to 8 days ]
• Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312 [ Time Frame: Up to 14 weeks ]
• Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312 [ Time Frame: Up to 14 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CSL312 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 CSL312 in Subjects With Idiopathic Pulmonary Fibrosis
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Idiopathic Pulmonary Fibrosis

Intervention

• Drug: CSL312
  Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
  Other Names:

  • Factor XIIa antagonist monoclonal antibody
  • Garadacimab
• Drug: Placebo
  Same as the CSL312 formulation buffer

Study Arms

• Experimental: CSL312
  Administered IV and SC
  Intervention: Drug: CSL312
• Placebo Comparator: Placebo
  Administered IV and SC
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2024): 81
• Original Estimated Enrollment (submitted: November 12, 2021): 80
• Actual Study Completion Date: January 2, 2024
• Actual Primary Completion Date: January 2, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Poland, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT05130970
• Other Study ID Numbers: CSL312_2002; 2021 003162 12 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: 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.

• Current Responsible Party: CSL Behring
• Original Responsible Party: Same as current
• Current Study Sponsor: CSL Behring
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Study Director; CSL Behring

• PRS Account: CSL Behring
• Verification Date: February 2024