CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05130970
• Other study ID #: CSL312_2002
• Secondary ID: 2021 003162 12
• Status: Completed
• Phase: Phase 2
• Start date: January 27, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: February 2024
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2, 2024
• Est. primary completion date: January 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
• Placebo
Same as the CSL312 formulation buffer

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Austria	Medizinische Univerität Graz	Graz
Austria	Kepler Universitätsklinikum	Linz
Belgium	Universitair Ziekenhuis (UZ) Leuven	Leuven
Belgium	Centre Hospitalier Universitaire Sart Tilman	Liège
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Dr. Syed Anees Medicine Professional Corporation	Windsor	Ontario
Denmark	Odense Universitetshospital - Lungemedicinsk Forskningsenhed	Odense
Germany	Fachkrankenhaus Coswig GmbH	Coswig
Germany	Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)	Essen
Germany	Medizinische Hochschule Hannover - Klinik für Pneumologie	Hannover
Germany	Petrus Krankenhaus Wuppertal	Wuppertal
Italy	Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia	Foggia
Poland	Centrum Medycyny Oddechowej Bialymstoku	Bialystok
Poland	Twoja Przychodnia Centrum Medyczne Nowa Sol	Nowa Sol
Poland	Centrum Badan Klinicznych NZOZ	Wroclaw
Spain	Giromed Institute, SLP	Barcelona
Spain	Hospital Universitario Puerta del Mar (HUPM)	Cadiz
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Altnagelvin Area Hospital	Londonderry
United Kingdom	Manchester Univ NHS - Wythenshawe Hospital	Manchester
United Kingdom	The Churchill Hospital - Oxford University Hospitals NHS Trust	Oxford	MD
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	Meris Clinical Research	Brandon	Florida
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor Scott and White Health - Advanced Lung Disease Specialists	Dallas	Texas
United States	Elite Medical Research	Dallas	Texas
United States	Southwest Family Medicine Associates	Dallas	Texas
United States	Clinical Trial Center of Middle Tennesse	Franklin	Tennessee
United States	Hannibal Clinic	Hannibal	Missouri
United States	Baylor College of Medicine	Houston	Texas
United States	National Institute of Clinical Research	Huntington Beach	California
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Southern California - Center for Advanced Lung Disease	Los Angeles	California
United States	Reliant Medical Research	Miami	Florida
United States	US Associates in Research LLC	Miami	Florida
United States	Lakes Research	Miami Lakes	Florida
United States	Weill Cornell Medical Center	New York	New York
United States	Renstar Medical Research	Ocala	Florida
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of California Irvine	Orange	California
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	Temple University TMS	Philadelphia	Pennsylvania
United States	Pulmonary Associates Clinical Trials AZ	Phoenix	Arizona
United States	Jadestone Clinical Research	Silver Spring	Maryland
United States	Superior Clinical Research	Smithfield	North Carolina
United States	Southeastern Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-emergent serious adverse events (SAEs) for CSL312 or placebo		Up to 22 weeks
Primary	Percent of participants with SAEs for CSL312 or placebo		Up to 22 weeks
Primary	Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo		Up to 22 weeks
Primary	Percent of participants with AESIs for CSL312 or placebo		Up to 22 weeks
Primary	Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)		Up to 14 weeks
Primary	Percent of participants with CSL312 induced ADAs		Up to 14 weeks
Primary	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
Primary	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	Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312		Up to 14 weeks
Secondary	Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312		Up to 14 weeks
Secondary	Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312		Up to 14 weeks
Secondary	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
Secondary	Ctrough after intravenous (IV) administration of CSL312		Up to 8 days
Secondary	Cmax after IV administration of CSL312		Up to 8 days
Secondary	Tmax after IV administration of CSL312		Up to 8 days
Secondary	Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312		Up to 14 weeks
Secondary	Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312		Up to 14 weeks