Ultomiris 300 mg/30 mL concentrate for solution for infusion
Sponsors
Alexion Pharmaceuticals Inc., Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre, Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre, Radboud universitair medisch centrum Stichting
Conditions
Hematopoietic stem cell transplant-associated thrombotic microangiopathyHematopoietic stem cell transplant-associated thrombotic microangiopathy(HSCT- TMA)IgA nephropathyLupus Nephritis (LN)
Immunoglobulin A Nephropathy (IgAN)Paroxysmal nocturnal hemoglobinuria (PNH)Patients with Paroxysmal Nocturnal HemoglobinuriaPrevention of cardiac surgery associated acute kidney injury
Phase 2
Phase 3
ARTEMIS: RAvulizumab to PRotect PaTients with Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
Active, not recruitingCTIS2022-501802-36-00
Start: 2023-06-16Target: 270Updated: 2025-07-17
A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants (from 1 month to <18 years of age) with Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplantation (HSCT)
CompletedCTIS2023-507850-33-00
Start: 2021-02-05End: 2025-05-27Target: 14Updated: 2025-03-19
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Ravulizumab in Adult and Adolescent Participants who have Thrombotic Microangiopathy (TMA) after Hematopoietic Stem Cell Transplant (HSCT)
Active, not recruitingCTIS2023-510107-22-00
Start: 2020-10-27Target: 61Updated: 2025-07-09
A PILOT PROOF-OF–CONCEPT STUDY TO ASSESS THE EFFICACY AND SAFETY OF A 6 MONTHS RAVULIZUMAB TREATMENT IN PATIENTS WITH FLARES OF CORTICOSTEROID-RESISTANT IDIOPATHIC IgA NEPHROPATHY
Active, not recruitingCTIS2024-512154-24-00
Start: 2023-05-26Target: 15Updated: 2024-06-28
A Long-term Extension (LTE) Study to Characterize the Safety and Efficacy of Danicopan as an Add-on Therapy to a Complement Component 5 Inhibitor (C5i) in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Previously Treated with Danicopan in an Alexion-sponsored Clinical Study.
Active, not recruitingCTIS2023-504867-18-00
Start: 2022-12-05Target: 25Updated: 2025-12-18