Abstract: SA-OR049
Crovalimab for Adults/Adolescents with Atypical Hemolytic Uremic Syndrome: Phase 3 COMMUTE-a Trial
Session Information
- Glomerular Diseases: Clinical Trial Results
October 24, 2026 | Location: Mile High Ballroom 4A, Convention Center
Abstract Time: 05:00 PM - 05:10 PM
Category: Glomerular Diseases
- 1402 Glomerular Diseases: Clinical, Outcomes, and Therapeutics
Authors
- Dixon, Bradley P., Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
- Brinkkoetter, Paul T., Department II of Internal Medicine and Center for Molecular Medicine Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany
- Cataland, Spero R., Division of Hematology, Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio, United States
- Eren, Necmi, Department of Nephrology, Kocaeli University, Kocaeli, Turkey
- Gomez-Navarro, Benjamin, Department of Nephrology and Transplant Hospital Puerta de Hierro, Zapopan, Jalisco, Mexico
- Machado, David, Kidney Transplant Service, Clinical Hospital of the University of São Paulo Medical School (HCFMUSP), São Paulo, Brazil
- Miyakawa, Yoshitaka, Department of Hematology, Saitama Medical University, Saitama, Japan
- Modelli de Andrade, Luis Gustavo, Department of Internal Medicine, São Paulo State University (UNESP), São Paulo, Brazil
- Souza, Pedro Augusto Macedo, Department of Nephrology, Santa Casa de Belo Horizonte, Belo Horizonte, Brazil
- Viazzi, Francesca, Department of Internal Medicine, University of Genoa and the Nephrology, Dialysis and Transplant Unit, IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM) Plesso Ospedale San Martino, Genova, Italy
- Khemais, Sonia, F. Hoffmann-La Roche Ltd, Basel, Switzerland
- Zhao, Minghui, Renal Division, Peking University First Hospital and Peking University Institute of Nephrology, Beijing, China
Background
COMMUTE-a (NCT04861259) is a single-arm Phase III study of crova, a novel C5 inhibitor (C5i) that allows for low-volume subcutaneous administration up to every 4 wks, in adults/adolescents with aHUS. Primary analysis (PA) results are shown.
Methods
Pts aged ≥12 years and weighing ≥40 kg enrolled into C5i-naive or switch (if switching from ecu/ravu) cohorts received crova during a 24-wk primary treatment period, followed by an optional continuation period. Efficacy was assessed during the first 24 wks. The primary efficacy endpoint (EP) was the proportion of naive pts with cTMAr from BL toWk25. Key secondary efficacy EPs included time to cTMAr, mTMAc [A1] from BL to Wk25, change from BL in dialysis status, CKD stage, eGFR, platelet normalization, and fatigue assessed with FACIT-Fatigue (adults). Exploratory EPs included time to dialysis discontinuation (post-hoc), hemoglobin response, treatment preference in switch pts at Wk17, and fatigue assessed with PedsQL-MFS (adolescents). Safety was assessed until the PA clinical cutoff date (Oct 9, 2025).
Results
Results: 41 naive and 41 switch pts enrolled. The primary EP was met; 59.5% of naive pts had cTMAr (median onset 85.0 days), with consistent results seen for secondary/exploratory EPs (Table). 100% of switch pts had mTMAc; strong treatment preference for crova was seen. 78.1% of naive pts had improved CKD stage. 100% of naive pts who were on dialysis at BL became dialysis-independent by Wk25. Median time to dialysis discontinuation was 2.6 wks. Most switch pts (84.6%) had stable/improved CKD. Crova was well tolerated (Table). 9.8% of switch pts had transient immune complex reactions (mostly grade 1/2); all resolved within 13 days.
Conclusion
These data support crova’s efficacy and favorable benefit–risk profile in aHUS.
Previously submitted: ERA 2026
Funding
- Commercial Support – F. Hoffmann-La Roche Ltd