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Активно (без набиране) Фаза 3 NCT04963296

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus

Фаза 3 – широко изпитване преди одобрение
Заболявания: Systemic Lupus Erythematosus

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.
Кой може да участва
Inclusion Criteria: * Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria \>=12 weeks prior to screening * Anti-nuclear antibody (ANA) \>=1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening * Low C3 or low C4 or low CH50 complement as determined by the central laboratory at screening * High disease activity at screening, based on; BILAG-2004 (Category A disease in \>=1 organ system and/or Category B disease in \>=2 organ systems), Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) (score \>=8) and Physician's Global Assessment (PGA) (score \>=1.0 on a 0 to 3 visual analogue scale \[VAS\]) * High disease activity on Day 1, based on; SLEDAI-2K (score \>=8) and PGA (score \>=1.0 on a 0 to 3 VAS) * Current receipt of \>=1 of the following classes of standard therapies for the treatment of SLE at stable doses: oral corticosteroid (OCS), antimalarials, conventional immunosuppressants * Other inclusion criteria may apply * The Medical Monitor may be consulted if there are any questions related to eligibility criteria Exclusion Criteria: * Pregnancy or breastfeeding * Presence of significant lupus-associated renal disease and/or renal impairment * Receipt of an excluded therapy, including any anti-CD20, anti-CD19 therapy less than 9 months prior to screening or during screening; or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening * Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude patient participation * Known active infection of any kind or recent major episode of infection * Intolerance or contraindication to study therapies * Other exclusion criteria may apply
Места на провеждане 14
Argentina (1)
Organizacion Medica de Investigacion
Buenos Aires
Бразилия (1)
Ser Servicos Especializados Em Reumatologia
Salvador , Estado de Bahia
Чехия (1)
Revmatologicky Ustav
Prague
Франция (1)
Ch Pitie Salpetriere
Paris
Италия (1)
Policlinico Universitario Agostino Gemelli
Rome , Lazio
Mexico (1)
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón , Coahuila
New Zealand (1)
Middlemore Hospital
Auckland
Peru (1)
Hogar Clínica San Juan de Dios
Arequipa
Полша (1)
Szpital Uniwersytecki
Bydgoszcz
Russia (1)
Republican clinical hospital named after G.G. Kuvatov
Ufa , Bashkortostan Republic
South Africa (1)
Panorama Medical Center
Cape Town
Испания (1)
Hospital Universitario Vall d'Hebron
Barcelona
Великобритания (1)
Addenbrooke'S Hospital
Cambridge
САЩ (1)
Pinnacle Research Group
Anniston , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
26.10.2021
Крайна дата
14.03.2028
Регистрационен номер
NCT04963296
Източник
anzctr
Запитване за медицински туризъм

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