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

Официальное название

Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (I TRANSCEND)

Обзор

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.

Вмешательства

• Препарат Placebo
  Participants will receive placebo.
• Препарат Tarperprumig
  Participants will receive tarperprumig.

Первичные конечные точки

• Number of Participants With Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Baseline through Week 70]

Вторичные конечные точки (12)

• Number of Participants Achieving Disease Remission at Week 26 [Срок оценки: Week 26]
• Number of Participants Achieving Sustained Remission at Week 52 [Срок оценки: Week 52]
• Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 [Срок оценки: Baseline through Week 52]
• Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26 [Срок оценки: Week 26 through Week 70]
• Time to First Relapse After Having Achieved Disease Remission at Week 26 [Срок оценки: Week 26 through Week 70]
• Change from Baseline in Vasculitis Damage Index [Срок оценки: Baseline, Weeks 26, and 52]
• Time to First Occurrence of BVAS of 0 [Срок оценки: Baseline through Week 52]
• Change from Baseline in BVAS [Срок оценки: Baseline, Weeks 26, and 52]
• Change from Baseline in Estimated Glomerular Filtration Rate [Срок оценки: Baseline, Weeks 26, and 52]
• Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio [Срок оценки: Baseline, Weeks 26, and 52]
• Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio [Срок оценки: Baseline, Weeks 26, and 52]
• Change from Baseline in Hematuria [Срок оценки: Baseline, Weeks 26, and 52]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

South Korea · 9 центров

• Research Site — Daegu
• Research Site — Daegu
• Research Site — Daejeon
• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul
• Research Site — Seoul
• … и ещё 1 центр

Бразилия · 7 центров

• Research Site — Barretos
• Research Site — Belo Horizonte
• Research Site — Porto Alegre
• Research Site — Recife
• Research Site — São Paulo
• Research Site — São Paulo
• Research Site — São Paulo

Китай · 7 центров

• Research Site — Baotou
• Research Site — Пекин
• Research Site — Пекин
• Research Site — Гуанчжоу
• Research Site — Ханчжоу
• Research Site — Nanchang
• Research Site — Шэньчжэнь

Аргентина · 6 центров

• Research Site — Ciudad de Buenos Aires
• Research Site — Ciudad de Buenos Aires
• Research Site — La Plata
• Research Site — Rosario
• Research Site — San Juan Bautista
• Research Site — Santa Fe

Канада · 6 центров

• Research Site — Calgary
• Research Site — Edmonton
• Research Site — Etobicoke
• Research Site — Hamilton
• Research Site — Toronto
• Research Site — Montreal

Turkey (Türkiye) · 6 центров

• Research Site — Altındağ
• Research Site — Ankara
• Research Site — Center
• Research Site — Istanbul
• Research Site — Istanbul
• Research Site — Kocaeli

Великобритания · 6 центров

• Research Site — Birmingham
• Research Site — Cambridge
• Research Site — Leicester
• Research Site — London
• Research Site — London
• Research Site — Manchester

Франция · 5 центров

• Research Site — Marseille
• Research Site — Paris
• Research Site — Paris
• Research Site — Strasbourg
• Research Site — Toulouse

Германия · 5 центров

• Research Site — Berlin
• Research Site — Essen
• Research Site — Göttingen
• Research Site — Ludwigshafen
• Research Site — München

Испания · 5 центров

• Research Site — Barcelona
• Research Site — Pamplona
• Research Site — San Sebastián de los Reyes
• Research Site — Santander
• Research Site — Seville

Австралия · 4 центра

• Research Site — Clayton
• Research Site — Heidelberg
• Research Site — Nedlands
• Research Site — Wollongong

Италия · 4 центра

• Research Site — Brescia
• Research Site — Padova
• Research Site — Pavia
• Research Site — Pisa

Польша · 4 центра

• Research Site — Gdansk
• Research Site — Krakow
• Research Site — Poznan
• Research Site — Warsaw

Тайвань · 4 центра

• Research Site — Kaohsiung City
• Research Site — Taichung
• Research Site — Taipei
• Research Site — Taoyuan

Идентификаторы

NCT: NCT07160608 · D6722C00001 · 2025-521706-17-00 · ALXN1820-ANCA-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗