Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis

NCT05130970 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CSL312_20022021 003162 12
• Study Type: interventional
• Target: 81
• Locations: 10 countries
• Sites: 45

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 garadacimab in subjects with idiopathic pulmonary fibrosis (IPF).

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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.

  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.

  Up to 22 weeks

• Number of Participants With Garadacimab Induced Anti Drug Antibodies (ADAs) in Plasma

  At Day 36 and Day 92 after the first treatment

• Percentage of Participants With Garadacimab Induced ADAs in Plasma

  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)

  Up to 14 weeks after treatment

• Percentage of Participants With TE Clinically Significant Abnormalities in Laboratory Assessments Reported as AEs

  Up to 14 weeks after treatment

Secondary Outcomes (9)

• Trough Plasma Concentration (Ctrough) After SC Administration of Garadacimab

  At Day 36 and Day 64

• Maximum Plasma Concentration (Cmax) (Last SC Dosing Interval Only) of Garadacimab

  After dosing on Day 64

• Time to Maximum Plasma Concentration (Tmax) (Last SC Dosing Interval Only) of Garadacimab

  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

  After dosing on Day 64

• Ctrough After IV Administration of Garadacimab

  At Day 8

Study Arms (2)

Garadacimab

EXPERIMENTAL

Administered IV and SC

Drug: Garadacimab

Placebo

PLACEBO COMPARATOR

Administered IV and SC

Drug: Placebo

Interventions

Garadacimab DRUG

Participants received garadacimab intravenous (IV) loading dose followed by 3 subcutaneous (SC) doses.

Also known as: Factor XIIa antagonist monoclonal antibody, CSL312

Garadacimab

Placebo DRUG

Participants received a matching placebo IV loading dose, followed by 3 SC doses.

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 40 years of age
• Documented diagnosis of IPF

You may not qualify if:

• 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

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (47)

The University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Pulmonary Associates Clinical Trials AZ

Phoenix, Arizona, 85032, United States

Location

National Institute of Clinical Research

Huntington Beach, California, 92647, United States

Location

University of Southern California - Center for Advanced Lung Disease

Los Angeles, California, 90033, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Meris Clinical Research

Brandon, Florida, 33511, United States

Location

Reliant Medical Research

Miami, Florida, 33165, United States

Location

US Associates in Research LLC

Miami, Florida, 33175, United States

Location

Lakes Research

Miami Lakes, Florida, 33014, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Jadestone Clinical Research

Silver Spring, Maryland, 20904, United States

Location

Hannibal Clinic

Hannibal, Missouri, 63401, United States

Location

Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Superior Clinical Research

Smithfield, North Carolina, 27577, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Temple University TMS

Philadelphia, Pennsylvania, 19140, United States

Location

Clinical Trial Center of Middle Tennesse

Franklin, Tennessee, 37067, United States

Location

Elite Medical Research

Dallas, Texas, 75230, United States

Location

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

Location

Baylor Scott and White Health - Advanced Lung Disease Specialists

Dallas, Texas, 75246, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Royal Adelaide Hospital

Adelaide, 5000, Australia

Location

Medizinische Univerität Graz

Graz, 8036, Austria

Location

Kepler Universitätsklinikum

Linz, 4021, Austria

Location

Universitair Ziekenhuis (UZ) Leuven

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman

Liège, 4000, Belgium

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Dr. Syed Anees Medicine Professional Corporation

Windsor, Ontario, N8X 1T3, Canada

Location

Odense Universitetshospital - Lungemedicinsk Forskningsenhed

Odense, 5000, Denmark

Location

Fachkrankenhaus Coswig GmbH

Coswig, 01640, Germany

Location

Universitaetsklinikum Essen - Ruhrlandklinik (Westdeutsches Lungenzentrum)

Essen, 45239, Germany

Location

Medizinische Hochschule Hannover - Klinik für Pneumologie

Hanover, 30625, Germany

Location

Petrus Krankenhaus Wuppertal

Wuppertal, 42283, Germany

Location

Azienda Ospedaliera Universitaria Ospedali Riuniti Foggia

Foggia, 71122, Italy

Location

Centrum Medycyny Oddechowej Bialymstoku

Bialystok, 15-044, Poland

Location

Twoja Przychodnia Centrum Medyczne Nowa Sol

Nowa Sól, 67-100, Poland

Location

Centrum Badań Klinicznych NZOZ

Wroclaw, 51-162, Poland

Location

Giromed Institute, SLP

Barcelona, 08006, Spain

Location

Hospital Universitario Puerta del Mar (HUPM)

Cadiz, 11009, Spain

Location

The Churchill Hospital - Oxford University Hospitals NHS Trust

Oxford, MD, OX3 7LE, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Altnagelvin Area Hospital

Londonderry, BT47 6SB, United Kingdom

Location

Manchester Univ NHS - Wythenshawe Hospital

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Trial Registration Coordinator
• Organization: CSL Behring LLC

clinicaltrials@cslbehring.com

610 878 4000

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 23, 2021
• Study Start: February 3, 2022
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

DK (1); AU (1); US (25); BE (2); DE (4); PL (3); GB (4); CA (2); IT (1); ES (2)