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Набира участници Фаза 2 NCT07160608

Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Спонсор: Alexion Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
Кой може да участва
Inclusion Criteria: * Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered. * Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for example, ELISA, bead assay). * At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS. Exclusion Criteria: * Other systemic diseases that, in the judgment of the Investigator, constitute the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgA associated vasculitis with or without Henoch-Schonlein purpura, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, or mixed connective tissue disease. * Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening. * Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study. * For patients with a previous diagnosis of CKD, patients known to have a stable eGFR for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.
Места на провеждане 14
Argentina (1)
Research Site
Ciudad de Buenos Aires
Австралия (1)
Research Site
Clayton
NOT_YET_RECRUITING
Бразилия (1)
Research Site
Barretos
Канада (1)
Research Site
Calgary , Alberta
NOT_YET_RECRUITING
Китай (1)
Research Site
Baotou
NOT_YET_RECRUITING
Франция (1)
Research Site
Marseille
Германия (1)
Research Site
Berlin
Италия (1)
Research Site
Brescia
Полша (1)
Research Site
Gdansk
Южна Корея (1)
Research Site
Daegu
WITHDRAWN
Испания (1)
Research Site
Barcelona
Taiwan (1)
Research Site
Kaohsiung City
Турция (1)
Research Site
Altındağ
Великобритания (1)
Research Site
Birmingham
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
26.11.2025
Крайна дата
14.02.2028
Регистрационен номер
NCT07160608
Източник
anzctr
Запитване за медицински туризъм

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