Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial

• Published in: Intensive care medicine Vol. 47; no. 11; pp. 1284 - 1294
• Main Authors: Laterre, Pierre-François, Pickkers, Peter, Marx, Gernot, Wittebole, Xavier, Meziani, Ferhat, Dugernier, Thierry, Huberlant, Vincent, Schuerholz, Tobias, François, Bruno, Lascarrou, Jean-Baptiste, Beishuizen, Albertus, Oueslati, Haikel, Contou, Damien, Hoiting, Oscar, Lacherade, Jean-Claude, Chousterman, Benjamin, Pottecher, Julien, Bauer, Michael, Godet, Thomas, Karakas, Mahir, Helms, Julie, Bergmann, Andreas, Zimmermann, Jens, Richter, Kathleen, Hartmann, Oliver, Pars, Melanie, Mebazaa, Alexandre
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.11.2021; Springer; Springer Nature B.V; Springer Verlag
• Subjects: Adrenomedullin; Adverse events; Anesthesiology; Antibodies; Antibodies, Monoclonal, Humanized - therapeutic use; Belgium; Biomarkers; Clinical trials; Comparative analysis; Confidence intervals; Critical Care Medicine; Double-Blind Method; Emergency Medicine; Ethylenediaminetetraacetic acid; France; Germany; Health aspects; Hemodynamics; Humans; Infection; Intensive; Intensive care; Life Sciences; Medicine; Medicine & Public Health; Mortality; NCT; NCT03085758; Original; Pain Medicine; Patients; Pediatrics; Pharmaceutical sciences; Placebos; Pneumology/Respiratory System; Randomization; Rankings; Safety; Sepsis; Septic shock; Shock, Septic - drug therapy; Treatment Outcome; Viral antibodies; Belgium; France; Germany; Adrenomedullin; Septic shock; Endothelial function; Adrecizumab (HAM8101); Enibarcimab

Purpose Investigate safety and tolerability of adrecizumab, a humanized monoclonal adrenomedullin antibody, in septic shock patients with high adrenomedullin. Methods Phase-2a, double-blind, randomized, placebo-controlled biomarker-guided trial with a single infusion of adrecizumab (2 or 4 mg/kg b.w...