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Soliris

BIOLOGICAL4 trials

Sponsors

Apellis Pharmaceuticals, Inc., Biocad, NovelMed Therapeutics

Conditions

Healthy SubjectsParoxysmal Nocturnal Hemoglobinuria

Phase 1

Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®
CompletedNCT04027803
BiocadHealthy Subjects
Start: 2018-09-21End: 2019-04-07Updated: 2020-05-15

Phase 2

Study of NM8074 in Adult PNH Patients With Inadequate Response to Soliris
Not yet recruitingNCT05646563
NovelMed TherapeuticsParoxysmal Nocturnal Hemoglobinuria
Start: 2027-01-01End: 2030-08-01Target: 12Updated: 2026-04-13

Phase 3

Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
CompletedNCT03500549
Apellis Pharmaceuticals, Inc.Paroxysmal Nocturnal Hemoglobinuria
Start: 2018-06-14End: 2020-08-13Updated: 2022-03-25
Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
CompletedNCT04060264
BiocadParoxysmal Nocturnal Hemoglobinuria
Start: 2019-04-04End: 2020-12-30Updated: 2021-02-12

Related Papers

Indirect treatment comparisons find enhanced effectiveness of pegcetacoplan versus crovalimab in both complement inhibitor-naïve and -experienced patients with paroxysmal nocturnal hemoglobinuria
Journal of Comparative Effectiveness Research2026-08-24
Consistent benefits of pegcetacoplan treatment in PNH patients with and without a history of aplastic anemia in real world: Analysis of the ongoing COMPLETE Phase IV observational study
Blood2025-11-03
Real-world clinical characteristics and treatment outcomes in PNH patients prescribed pegcetacoplan across europe, the United States and Canada
Blood2025-11-03
Overview of treatment advances with complement inhibitors in patients with paroxysmal nocturnal hemoglobinuria
Blood2025-11-03
Improved Iron Overload with Pegcetacoplan in Eculizumab-Experienced Patients with Paroxysmal Nocturnal Hemoglobinuria.
2025-10-15
Efficacy and Safety Maintained up to 3 Years in Adults with Paroxysmal Nocturnal Hemoglobinuria Receiving Pegcetacoplan.
2025-07-28
Anchored Indirect Treatment Comparison Finds Comparable Effects of Pegcetacoplan and Iptacopan in Paroxysmal Nocturnal Haemoglobinuria
European Journal Of Haematology2025-04-251 citations
Breakthrough Hemolysis Events in Patients with Paroxysmal Nocturnal Hemoglobinuria: Data from Danicopan and Pegcetacoplan Trials
Blood2024-11-052 citations
Anchored Indirect Treatment Comparison Finds Comparable Effects of Pegcetacoplan and Iptacopan in Paroxysmal Nocturnal Hemoglobinuria
Blood2024-11-05
Reduced Iron Overload with Pegcetacoplan Treatment in Eculizumab-Experienced Patients with Paroxysmal Nocturnal Hemoglobinuria
Blood2024-11-05
Moving toward Individual Treatment Goals with Pegcetacoplan in Patients with PNH and Impaired Bone Marrow Function
International Journal of Molecular Sciences2024-08-063 citations
Improvements in hematologic markers and decreases in fatigue with pegcetacoplan for patients with paroxysmal nocturnal hemoglobinuria and mild or moderate anemia (hemoglobin ≥10 g/dL) who had received eculizumab or were naive to complement inhibitors
PLoS ONE2024-07-291 citations
Normalization of Hemoglobin, Lactate Dehydrogenase, and Fatigue in Patients with Paroxysmal Nocturnal Hemoglobinuria Treated with Pegcetacoplan
Drugs in R&D2024-05-101 citations
Hemolysis events in the phase 3 PEGASUS study of pegcetacoplan in patients with paroxysmal nocturnal hemoglobinuria
Blood Advances2024-04-0913 citations
Management of acute breakthrough hemolysis with intensive pegcetacoplan dosing in patients with PNH
Blood Advances2024-02-0530 citations
Efficacy and Safety Is Maintained in Adult Patients with Paroxysmal Nocturnal Hemoglobinuria Receiving Pegcetacoplan for up to 3 Years
Blood2023-11-027 citations
Injection Site Reactions with Long-Term Pegcetacoplan Use in Patients with Paroxysmal Nocturnal Hemoglobinuria: A Brief Report.
2023-09-141 citations
The cost–effectiveness of pegcetacoplan in complement treatment-naïve adults with paroxysmal nocturnal hemoglobinuria in the USA
Journal of Comparative Effectiveness Research2023-09-016 citations
PB2064: THE COMPLETE STUDY: A SINGLE ARM, MULTICENTER OBSERVATIONAL STUDY TO EVALUATE EFFECTIVENESS OF PEGCETACOPLAN UNDER REAL WORLD CONDITIONS IN PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
HemaSphere2023-08-012 citations
P781: EVALUATION OF PEGCETACOPLAN TREATMENT SUCCESS IN PAROXYSMAL NOCTURNAL HEMOGLOBINURIA WITH AND WITHOUT BONE MARROW FAILURE: A MOVE TOWARDS INDIVIDUALIZED PATIENT TREATMENT
HemaSphere2023-08-011 citations

21 more papers not shown