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Last Updated: December 12, 2024

CLINICAL TRIALS PROFILE FOR SOLIRIS


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Biosimilar Clinical Trials for SOLIRIS

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT04058158 ↗ A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria Completed Samsung Bioepis Co., Ltd. Phase 3 2019-08-07 This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and SolirisĀ® in subjects with PNH.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for SOLIRIS

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00122317 ↗ Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Completed Alexion Pharmaceuticals Phase 3 2005-05-01 The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.
NCT00670774 ↗ Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant Completed Alexion Pharmaceuticals Phase 1/Phase 2 2008-03-01 A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant. Over the past decade, significant progress has been made in overcoming early antibody-mediated renal allograft injury. Our group has performed more than 200 such transplants providing the possibility of transplant to previously untransplantable patients. Despite our best efforts, transplantation in these patients is still complicated by a high rate of acute humoral rejection (AHR). Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor. It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody.
NCT00670774 ↗ Dosing Regimen of Eculizumab Added to Conventional Treatment in Positive Cross Match Living Donor Kidney Transplant Completed Mark Stegall Phase 1/Phase 2 2008-03-01 A strongly positive crossmatch has long been considered an absolute contraindication to kidney transplantation and most patients with anti-human leukocyte antigen (HLA) antibody never were able to receive a kidney transplant. Over the past decade, significant progress has been made in overcoming early antibody-mediated renal allograft injury. Our group has performed more than 200 such transplants providing the possibility of transplant to previously untransplantable patients. Despite our best efforts, transplantation in these patients is still complicated by a high rate of acute humoral rejection (AHR). Patients included in this study will be those who have demonstrable anti-HLA antibody specific for their living donor. It is our hypothesis that blockade of terminal complement activation at the time of transplant in combination with our current protocols will reduce the incidence of AHR in patients with anti-donor HLA antibody.
NCT00727194 ↗ Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia Gravis Terminated Alexion Pharmaceuticals Phase 2 2008-10-01 The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of patients with generalized myasthenia gravis despite treatment with various immunosuppressants, such as prednisone, methotrexate, Cellcept, cyclosporine, and cyclophosphamide, that are currently available.
NCT00867932 ↗ Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH) Completed Alexion Pharmaceuticals Phase 4 2009-10-02 The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH.
NCT00904826 ↗ An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica Completed Alexion Pharmaceuticals Phase 1/Phase 2 2009-04-01 The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica.
NCT00904826 ↗ An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica Completed Mayo Clinic Phase 1/Phase 2 2009-04-01 The purpose of this study is to determine if the drug eculizumab reduces the attack rate and improves outcome in patients with neuromyelitis optica.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SOLIRIS

Condition Name

Condition Name for SOLIRIS
Intervention Trials
Paroxysmal Nocturnal Hemoglobinuria 8
Neuromyelitis Optica 3
Kidney Transplant 3
Complement Abnormality 2
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Condition MeSH

Condition MeSH for SOLIRIS
Intervention Trials
Hemoglobinuria, Paroxysmal 14
Hemoglobinuria 14
Syndrome 5
Vascular Diseases 3
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Clinical Trial Locations for SOLIRIS

Trials by Country

Trials by Country for SOLIRIS
Location Trials
United States 143
Japan 20
Italy 17
Australia 16
Canada 14
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Trials by US State

Trials by US State for SOLIRIS
Location Trials
California 13
New York 11
Maryland 9
North Carolina 8
Minnesota 8
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Clinical Trial Progress for SOLIRIS

Clinical Trial Phase

Clinical Trial Phase for SOLIRIS
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 2/Phase 3 2
[disabled in preview] 33
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Clinical Trial Status

Clinical Trial Status for SOLIRIS
Clinical Trial Phase Trials
Completed 21
Terminated 8
Recruiting 7
[disabled in preview] 10
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Clinical Trial Sponsors for SOLIRIS

Sponsor Name

Sponsor Name for SOLIRIS
Sponsor Trials
Alexion Pharmaceuticals 25
Apellis Pharmaceuticals, Inc. 3
Mayo Clinic 3
[disabled in preview] 8
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Sponsor Type

Sponsor Type for SOLIRIS
Sponsor Trials
Industry 41
Other 26
NIH 3
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