trabikibart (CSL311) / CSL Behring - LARVOL DELTA

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: CSL Behring | Recruiting ➔ Completed

Trial completion • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Dual inhibition of airway inflammation and fibrosis by common beta cytokine receptor blockade. (PubMed, J Allergy Clin Immunol) - "βc cytokines drive steroid-resistant mixed myeloid cell airway inflammation and fibrosis. The anti-βc antibody CSL311 effectively inhibits mixed T2/neutrophilic inflammation and severe asthma-like pathology and reverses fibrosis gene signatures induced by exposure to commonly encountered environmental allergens."

Journal • Asthma • Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CSF2 • IL5

Evaluating CD131 as a potential target for reducing inflammation in chronic airway disease (EAACI 2023) - "The βc-cytokines were able to activate these effectors, which blockade of CD131 with CSL311 could inhibit. Inhibition of βc cytokine-induced activation, proliferation and cellular migration may provide a therapeutic benefit in airway inflammation."

Late-breaking abstract • Immunology • Inflammation • CR1 • IL5 • ITGAM • SELL

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=82 | Recruiting | Sponsor: CSL Behring | Trial completion date: Jan 2024 ➔ Oct 2023 | Trial primary completion date: Jan 2024 ➔ Oct 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Targeting the human β receptor inhibits inflammatory myeloid cells and lung injury caused by acute cigarette smoke exposure. (PubMed, Respirology) - "This study identifies CSL311 as a therapeutic antibody that potently inhibits immunopathology and lung injury caused by acute CS exposure."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL17A • IL5 • ITGAM

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=114 | Recruiting | Sponsor: CSL Behring | Active, not recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1 | N=114 | Active, not recruiting | Sponsor: CSL Behring | Trial completion date: Jun 2023 ➔ Jan 2024 | Trial primary completion date: Jun 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Blocking the human common beta subunit of the GM-CSF, IL-5 and IL-3 receptors markedly reduces hyperinflammation in ARDS models. (PubMed, Cell Death Dis) - "Furthermore, CSL311 treatment did not limit the viral-induced expansion of NK and NKT cells, or the tissue expression of type I/II/III interferons needed for efficient viral clearance. Simultaneously blocking GM-CSF, IL-5 and IL-3 signalling with CSL311 may represent an improved and clinically applicable strategy to reducing hyperinflammation in the ARDS setting."

Journal • Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock • CSF2 • IL5

Targeting the human β receptor inhibits contact dermatitis in a transgenic mouse model. (PubMed, J Invest Dermatol) - "Importantly, the blocking anti-human β antibody CSL311 strongly suppressed ear pinna thickening and histopathological changes typical of ACD and reduced accumulation of neutrophils, mast cells and eosinophils in the skin. These results show that GM-CSF and IL-5, but not IL-3 are major mediators of ACD and define the hβTg mouse as a unique platform to test inhibitors of βin vivo."

Journal • Preclinical • Contact Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • CSF2 • IL5

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Active, not recruiting; Sponsor: CSL Behring; Recruiting ➔ Active, not recruiting; Trial completion date: May 2022 ➔ Jun 2023; Trial primary completion date: May 2022 ➔ Jun 2023

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: CSL Behring; Trial completion date: Oct 2022 ➔ May 2022; Trial primary completion date: Oct 2022 ➔ May 2022

Trial completion date • Trial primary completion date • Asthma • Immunology • Neutropenia • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: CSL Behring; Trial completion date: May 2022 ➔ Oct 2022; Trial primary completion date: May 2022 ➔ Oct 2022

Clinical • Trial completion date • Trial primary completion date • Asthma • Immunology • Neutropenia • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers (clinicaltrials.gov) - P1; N=114; Recruiting; Sponsor: CSL Behring; N=82 ➔ 114; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: Nov 2021 ➔ May 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Asthma • Immunology • Neutropenia • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=82; Recruiting; Sponsor: CSL Behring; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Asthma • Neutropenia • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=82; Active, not recruiting; Sponsor: CSL Behring; Trial completion date: Apr 2021 ➔ Nov 2021; Trial primary completion date: Apr 2021 ➔ Nov 2021

Clinical • Trial completion date • Trial primary completion date • Asthma • Neutropenia • Respiratory Diseases

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=74; Active, not recruiting; Sponsor: CSL Behring; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL311 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=74; Recruiting; Sponsor: CSL Behring; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Anti-β mAb CSL311 inhibits human nasal polyp pathophysiology in a humanized mouse xenograft model. (PubMed, Allergy) - No abstract available.

Journal • Preclinical

A Clinical Study to Test the Safety, Exposure, and Markers of Efficacy of CSL31 in Patients With Mild Asthma (clinicaltrials.gov) - P1; N=74; Not yet recruiting; Sponsor: CSL Behring

Clinical • New P1 trial