CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 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 CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: CSL312; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Trial Registration Coordinator; Phone Number: +1 610-878-4000; Email: clinicaltrials@cslbehring.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: CSL Behring
• Investigators: Study Director: Study Director, CSL Behring

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Actual): January 2, 2024
• Study Completion (Actual): January 2, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID 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