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- ||||| Soliris (eculizumab) / AstraZeneca, Ultomiris (ravulizumab-cwvz) / AstraZeneca
Trial completion, Head-to-Head: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab (clinicaltrials.gov) - Oct 13, 2023
P3, N=136, Completed, Sponsor: Alexion
Active, not recruiting --> Completed
- |||| Soliris (eculizumab) / AstraZeneca, Ultomiris (ravulizumab-cwvz) / AstraZeneca
Enrollment closed, Phase classification, Head-to-Head: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab (clinicaltrials.gov) - Oct 20, 2022
P3, N=136, Active, not recruiting, Sponsor: Alexion Pharmaceuticals
Active, not recruiting --> Completed Withheld --> Active, not recruiting | Phase classification: PN/A --> P3
- Ultomiris SC QW (ravulizumab SC) / AstraZeneca, Empaveli (pegcetacoplan SC) / Apellis, SOBI
Treatment-Related Lost Productivity in Paroxysmal Nocturnal Hemoglobinuria: A Comparison of Investigational Subcutaneous Ravulizumab and Pegcetacoplan in the United States (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_727;
Compared with ravulizumab SC, patients with PNH treated with pegcetacoplan were estimated to experience from 4.2–14.1 times more treatment-related burden, resulting in higher lost productivity costs. These differences in treatment-related burden will affect patients, healthcare providers, payers, and society.
- Soliris (eculizumab) / AstraZeneca, crovalimab (RG6107) / Roche, Ultomiris IV (ravulizumab IV) / AstraZeneca
Two Currently Recruiting Randomized Phase III Trials: COMMODORE 1 and 2 Evaluating Crovalimab Vs Eculizumab in Patients with Paroxysmal Nocturnal Hemoglobinuria with or without Current Anti-Complement Therapy () - Nov 24, 2021 - Abstract #ASH2021ASH_6866;
P1/2, P3
The primary efficacy objective is to determine the non-inferiority of crovalimab vs eculizumab, based on the proportion of patients who 1) achieve transfusion avoidance from baseline to Week 25 and 2) with hemolysis control from Week 5-25 (co-primary efficacy endpoints). Safety and tolerability of crovalimab vs eculizumab will also be evaluated along with pharmacokinetic, immunogenicity, biomarker, and health status utility objectives.
- Pozelimab, a Human Monoclonal Antibody Against Complement Factor C5, Provided Inhibition of Intravascular Hemolysis in Patients with Paroxysmal Nocturnal Hemoglobinuria (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_2683;
P1, P2, P3
An update to the previously reported interim analysis will be provided. Upon successful completion of the 26-week treatment period, patients are enrolled into an open-label extension study.
- Soliris (eculizumab) / Alexion Pharma, crovalimab (RG6107) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
[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 () - May 13, 2021 - Abstract #EHA2021EHA_1203;
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.
- Soliris (eculizumab) / Alexion Pharma
[VIRTUAL] RAVULIZUMAB ADMINISTERED SUBCUTANEOUSLY VERSUS INTRAVENOUSLY IN ADULT PATIENTS WITH PNH PREVIOUSLY TREATED WITH ECULIZUMAB: RESULTS FROM A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY () - May 13, 2021 - Abstract #EHA2021EHA_1181;
P=N/A
Conclusion Ravulizumab SC Ctrough levels were non-inferior to those obtained with ravulizumab IV. Ravulizumab SC provided complete and sustained free C5 inhibition comparable to ravulizumab IV at all timepoints.
- Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma, pozelimab (REGN3918) / Regeneron
[VIRTUAL] POZELIMAB INHIBITS HEMOLYSIS IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) () - May 16, 2020 - Abstract #EHA2020EHA_1020;
P1, P2
Conclusion Pozelimab administered subcutaneously once weekly provided inhibition of intravascular hemolysis, with normalization of LDH at day 57 in all 6 evaluated patients with PNH, including a patient with a known C5 variant resistant to prior eculizumab therapy. The dose regimen used in Cohort A is confirmed as each of the first 6 patients enrolled achieved a reduction in LDH to ≤1.5 x ULN by study day 57.
- Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma, pozelimab (REGN3918) / Regeneron
Pozelimab, a Human Antibody Against Complement Factor C5, Demonstrates Robust Inhibition of Alternative Complement Activity Both in Normal Human Serum and in Phase I Normal Healthy Volunteers (Hall B, Level 2 (Orange County Convention Center)) - Nov 7, 2019 - Abstract #ASH2019ASH_3430;
In-house ravulizumab appeared to be less potent compared with in-house eculizumab in both CP and AP hemolysis assays . The Phase I healthy volunteer study of pozelimab demonstrated dose-dependent and significant inhibition of alternative pathway hemolysis, with the maximal suppression of hemolysis approximately −85% change from baseline.
- | Soliris (eculizumab) / AstraZeneca, Ultomiris (ravulizumab-cwvz) / AstraZeneca
New P3 trial, Head-to-Head: Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab (clinicaltrials.gov) - Feb 12, 2019
P3, N=105, Withheld, Sponsor: [Redacted]