ravulizumab/hyaluronidase (ALXN1810 SC) / Halozyme, AstraZeneca - LARVOL DELTA

[VIRTUAL] TWO CURRENTLY RECRUITING PHASE III TRIALS: COMMODORE 1 AND 2 EVALUATING CROVALIMAB VS ECULIZUMAB IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WITH OR WITHOUT CURRENT ANTI–COMPLEMENT THERAPY (EHA 2021) - P1/2, P3 | "Treatment with approved C5 inhibitors eculizumab or ravulizumab is effective but can be limited by breakthrough hemolysis (BTH) due to unsustained C5 inhibition, inadequate efficacy in patients with C5 mutational variants and the requirement of regular intravenous (IV) infusions...Results COMMODORE 1 and 2 are now enrolling. Conclusion The COMMODORE 1 and 2 studies aim to assess the efficacy and safety of crovalimab in patients with PNH, compared with eculizumab, in patients with or without prior complement inhibition."

Clinical • P3 data • Anemia • Cardiovascular • Complement-mediated Rare Disorders • Fatigue • Hematological Disorders • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombosis

[VIRTUAL] Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 1 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with Complement Inhibitors (ASH 2020) - P1/2, P3 | "The safety objective is to evaluate the safety and tolerability of crovalimab compared with eculizumab based on the incidence and severity of adverse events, including infections (meningococcal meningitis and other infections), injection-site reactions, infusion-related reactions, hypersensitivity, adverse events leading to study drug discontinuation, and type 3 hypersensitivity reactions in patients who switch to crovalimab from eculizumab or ravulizumab. Pharmacokinetic, immunogenicity, biomarker, and health status utility objectives will also be assessed. Antonio Risitano and Alexander Röth are equal co-first authors."

Clinical • P3 data • Cardiovascular • CNS Disorders • Complement-mediated Rare Disorders • Fatigue • Hematological Disorders • Immunology • Infectious Disease • Paroxysmal Nocturnal Hemoglobinuria • Rare Diseases • Thrombosis

Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: Alexion Pharmaceuticals

New P1 trial