Soliris® ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
62発作性夜間ヘモグロビン尿症5

62. 発作性夜間ヘモグロビン尿症


臨床試験数 : 292 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1NCT05646563
(ClinicalTrials.gov)
September 202330/11/2022Study of NM8074 in Adult PNH Patients With Inadequate Response to SolirisA Phase II, Open-Label Study of NM8074 in Soliris®-Treated Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)Paroxysmal Nocturnal HemoglobinuriaDrug: NM8074;Drug: SolirisNovelMed TherapeuticsNULLNot yet recruiting18 YearsN/AAll12Phase 2NULL
2EUCTR2020-000597-26-PT
(EUCTR)
18/05/202123/12/2020A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
MedDRA version: 21.1;Level: PT;Classification code 10034042;Term: Paroxysmal nocturnal haemoglobinuria;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Crovalimab
Product Code: RO7112689
INN or Proposed INN: CROVALIMAB
Trade Name: SOLIRIS® (eculizumab) injection, for intravenous use
Product Name: Eculizumab
INN or Proposed INN: ECULIZUMAB
F.Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Estonia;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Colombia;Italy;France;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Germany;Japan;Sweden
3NCT04058158
(ClinicalTrials.gov)
August 7, 201912/8/2019A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal HaemoglobinuriaA Phase III Randomised, Double-blind, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB12 (Proposed Eculizumab Biosimilar) and Soliris® in Subjects With Paroxysmal Nocturnal HaemoglobinuriaParoxysmal Nocturnal HemoglobinuriaDrug: SB12 (proposed eculizumab biosimilar);Drug: Soliris (eculizumab)Samsung Bioepis Co., Ltd.NULLCompleted18 YearsN/AAll50Phase 3India;Korea, Republic of;Malaysia;Mexico;Romania;Taiwan;Thailand;Ukraine
4NCT04060264
(ClinicalTrials.gov)
April 4, 201913/8/2019Clinical Trial of BCD-148 and Soliris® for the Treatment of Patients With Paroxysmal Nocturnal HemoglobinuriaRandomized, Open-Label, International, Multi-center, Comparative Study of Efficacy and Safety of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Patients With Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal HemoglobinuriaBiological: BCD-148;Biological: SolirisBiocadNULLCompleted18 Years65 YearsAll28Phase 3Russian Federation
5NCT04463056
(ClinicalTrials.gov)
November 29, 20173/7/2020Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNHA Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal Hemoglobinuria;Marchiafava-Micheli Syndrome;Paroxysmal HemoglobinuriaBiological: Elizaria®;Biological: Soliris®AO GENERIUMNULLCompleted18 Years75 YearsAll32Phase 3Russian Federation