Cargando…

A Randomized, First‐in‐Human, Healthy Volunteer Trial of sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway

Aberrant activation of the classical complement pathway is the common underlying pathophysiology of orphan diseases such as bullous pemphigoid, antibody‐mediated rejection of organ transplants, cold agglutinin disease, and warm autoimmune hemolytic anemia. Therapeutic options for these complement‐me...

Descripción completa

Detalles Bibliográficos
Autores principales:	Bartko, Johann, Schoergenhofer, Christian, Schwameis, Michael, Firbas, Christa, Beliveau, Martin, Chang, Colin, Marier, Jean‐Francois, Nix, Darrell, Gilbert, James C., Panicker, Sandip, Jilma, Bernd
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2018
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175298/ https://www.ncbi.nlm.nih.gov/pubmed/29737533 http://dx.doi.org/10.1002/cpt.1111

Ejemplares similares

Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing
por: Schoergenhofer, Christian, et al.
Publicado: (2018)

Safety, tolerability, pharmacokinetics and pharmacodynamics of parenterally administered dutogliptin: A prospective dose‐escalating trial
por: Buchtele, Nina, et al.
Publicado: (2020)

Defibrotide enhances fibrinolysis in human endotoxemia – a randomized, double blind, crossover trial in healthy volunteers
por: Schoergenhofer, Christian, et al.
Publicado: (2019)

Blockade of HLA Antibody-Triggered Classical Complement Activation in Sera From Subjects Dosed With the Anti-C1s Monoclonal Antibody TNT009—Results from a Randomized First-in-Human Phase 1 Trial
por: Mühlbacher, Jakob, et al.
Publicado: (2017)

Dissociation between systemic and pulmonary anti‐inflammatory effects of dexamethasone in humans
por: Bartko, Johann, et al.
Publicado: (2016)

The use of frozen plasma samples in thromboelastometry
por: Schoergenhofer, Christian, et al.
Publicado: (2017)

Safety and efficacy of classical complement pathway inhibition with sutimlimab in chronic immune thrombocytopenia
por: Broome, Catherine M., et al.
Publicado: (2022)

Dexamethasone inhibits endotoxin‐induced coagulopathy in human lungs
por: Bartko, J., et al.
Publicado: (2016)

Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study of the Penetration of a Monoclonal Antibody Combination (ASN100) Targeting Staphylococcus aureus Cytotoxins in the Lung Epithelial Lining Fluid of Healthy Volunteers
por: Magyarics, Zoltan, et al.
Publicado: (2019)

Granulocyte colony-stimulating factor (G-CSF) increases histone-complexed DNA plasma levels in healthy volunteers
por: Schoergenhofer, Christian, et al.
Publicado: (2016)

Sustained hematologic remission after discontinuation of sutimlimab treatment in patients with cold agglutinin disease
por: Gelbenegger, Georg, et al.
Publicado: (2022)

Surface cooling for induction of mild hypothermia in conscious healthy volunteers - a feasibility trial
por: Testori, Christoph, et al.
Publicado: (2011)

Advanced pharmacodynamics of cangrelor in healthy volunteers: a dose-finding, open-label, pilot trial
por: Gelbenegger, Georg, et al.
Publicado: (2022)

Morphine interaction with prasugrel: a double-blind, cross-over trial in healthy volunteers
por: Hobl, Eva-Luise, et al.
Publicado: (2015)

High Titer Persistent Neutralizing Antibodies Induced by TSST-1 Variant Vaccine Against Toxic Shock Cytokine Storm
por: Roetzer, Andreas, et al.
Publicado: (2020)

The von Willebrand factor–binding aptamer rondaptivon pegol as a treatment for severe and nonsevere hemophilia A
por: Ay, Cihan, et al.
Publicado: (2023)

Corticosteroid Treatment Prevents Lipopolysaccharide-Induced Increase of ACE2 and Reduces Fibrin Degradation Products in Bronchoalveolar Lavage Fluid
por: Reindl-Schwaighofer, Roman, et al.
Publicado: (2022)

The von Willebrand factor A-1 domain binding aptamer BT200 elevates plasma levels of von Willebrand factor and factor VIII: a first-in-human trial
por: Kovacevic, Katarina D., et al.
Publicado: (2021)

Complement C1s inhibition with sutimlimab results in durable response in cold agglutinin disease: CARDINAL study 1-year interim follow-up results
por: Röth, Alexander, et al.
Publicado: (2022)

Chikungunya vaccines in development
por: Schwameis, Michael, et al.
Publicado: (2015)

Sutimlimab for the Treatment of Cold Agglutinin Disease
por: Berentsen, Sigbjørn
Publicado: (2023)

Rhabdomyolysis Following Ad26.COV2.S COVID-19 Vaccination
por: Gelbenegger, Georg, et al.
Publicado: (2021)

P1471: SUSTAINED EFFICACY OF SUTIMLIMAB, A COMPLEMENT C1S INHIBITOR, IN PATIENTS WITH COLD AGGLUTININ DISEASE: RESULTS FROM PART B OF THE PHASE 3 CADENZA STUDY
por: Röth, Alexander, et al.
Publicado: (2023)

Sutimlimab in patients with cold agglutinin disease: results of the randomized placebo-controlled phase 3 CADENZA trial
por: Röth, Alexander, et al.
Publicado: (2022)

Human diamine oxidase is readily released from activated neutrophils ex vivo and in vivo but is rarely elevated in bacteremic patients
por: Boehm, Thomas, et al.
Publicado: (2020)

P1469: INHIBITION OF COMPLEMENT C1S WITH SUTIMLIMAB IN PATIENTS WITH COLD AGGLUTININ DISEASE (CAD): RESULTS FOLLOWING 9-WEEK OFF-TREATMENT PERIOD (WASHOUT) IN THE PHASE 3 CADENZA STUDY
por: Röth, Alexander, et al.
Publicado: (2023)

P1486: SERUM BIOMARKERS AS PREDICTORS OF RESPONSE TO SUTIMLIMAB IN COLD AGGLUTININ DISEASE (CAD): A POST-HOC ANALYSIS OF PHASE 3 CARDINAL AND CADENZA STUDY DATA
por: Barcellini, Wilma, et al.
Publicado: (2023)

Complement-Mediated Enhancement of Monocyte Adhesion to Endothelial Cells by HLA Antibodies, and Blockade by a Specific Inhibitor of the Classical Complement Cascade, TNT003
por: Valenzuela, Nicole M., et al.
Publicado: (2017)

P1538: INHIBITION OF COMPLEMENT C1S WITH SUTIMLIMAB IN PATIENTS WITH COLD AGGLUTININ DISEASE (CAD): RESULTS FOLLOWING 9-WEEK WASHOUT PERIOD IN PHASE 3 CARDINAL STUDY (NCT03347396)
por: Röth, A., et al.
Publicado: (2022)

LUBAC and ABIN-1 Modulate TRAIL-Based NF-κB Induction in Human Embryonic Kidney 293 Cells
por: Dorn, Sebastian, et al.
Publicado: (2018)

Low PCSK-9 levels Are Associated with Favorable Neurologic Function after Resuscitation from out of Hospital Cardiac Arrest
por: Merrelaar, Anne, et al.
Publicado: (2020)

Serum and Lung Pharmacokinetics of ASN100, a Monoclonal Antibody Combination for the Prevention and Treatment of Staphylococcus aureus Pneumonia
por: Magyarics, Zoltan, et al.
Publicado: (2017)

Angiotensin II for the treatment of vasodilatory shock: enough data to consider angiotensin II safe?
por: Buchtele, Nina, et al.
Publicado: (2018)

Targeting von Willebrand Factor in Ischaemic Stroke: Focus on Clinical Evidence
por: Buchtele, Nina, et al.
Publicado: (2018)

P1675: SUTIMLIMAB PROVIDES SUSTAINED IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES AND QUALITY OF LIFE IN PATIENTS WITH COLD AGGLUTININ DISEASE: OPEN-LABEL EXTENSION OF THE PHASE 3 CADENZA STUDY
por: Röth, Alexander, et al.
Publicado: (2023)

Bridging the Missing Link with Emicizumab: A Bispecific Antibody for Treatment of Hemophilia A
por: Gelbenegger, Georg, et al.
Publicado: (2020)

Acetylsalicylic acid in critically ill patients: a cross‐sectional and a randomized trial
por: Schoergenhofer, Christian, et al.
Publicado: (2017)

A New Tool for Complement Research: In vitro Reconstituted Human Classical Complement Pathway
por: Mutti, Michele, et al.
Publicado: (2018)

Multi-phasic life-threatening anaphylaxis refractory to epinephrine managed by extracorporeal membrane oxygenation (ECMO): A case report
por: Grafeneder, Juergen, et al.
Publicado: (2022)

Performance of a Qualitative Point-of-Care Strip Test to Detect DOAC Exposure at the Emergency Department: A Cohort-Type Cross-Sectional Diagnostic Accuracy Study
por: Merrelaar, Anne E., et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_lue808l0v2dlrtslf8ki74so0v