Идёт набор NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Фаза III С лечением Lupus Erythematosus, Systemic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Nipocalimab, Placebo, Standard of care treatment.
Кому может быть актуально: Состояния в реестре: Lupus Erythematosus, Systemic. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Бразилия, Болгария +24
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Обзор

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Вмешательства

Препарат Nipocalimab
Nipocalimab will be administered.
Препарат Placebo
Placebo will be administered.
Препарат Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.

Первичные конечные точки

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 [Срок оценки: Week 52]

Вторичные конечные точки (9)

Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high) [Срок оценки: Week 52]
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose [Срок оценки: Week 52]
Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52 [Срок оценки: Week 52]
Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline [Срок оценки: Week 52]
Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52 [Срок оценки: Baseline, Week 52]
Percentage of Participants Achieving Sustained Reduction in Oral GC Dose at Week 52 in Participants Treated with Oral GC >5 mg/Day Prednisone (or equivalent) at Baseline [Срок оценки: Week 52]
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 52 [Срок оценки: Baseline, Week 52]
Percentage of Participants With BILAG Flare Free Status Through Week 52 [Срок оценки: Up to Week 52]
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline Autoantibodies (Autoantibody High) [Срок оценки: Week 52]

Критерии участия

Inclusion Criteria:-

Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening
Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria
Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 and a clinical SLEDAI-2K >= 4 at screening, AND a clinical SLEDAI-2K score >= 4 points at Week 0. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded
Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization
Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

Критерии исключения

History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory
Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation

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: Двойное слепое
Основная цель: Лечение

Центры проведения

США · 35 центров

David S Hallegua MD A Professional Corporation — Beverly Hills
Providence Medical Foundation — Fullerton
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis — Hemet
Advanced Medical Research — La Palma
Medvin Clinical Research San Leandro — San Leandro
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
Solace Clinical Research California — Tustin
Inland Rheumatology Clinical Trials Inc. — Upland
… и ещё 27 центров

Китай · 18 центров

Peking University People's Hospital — Пекин
West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi
Dongguan People s Hospital — Дунгуань
The First Affiliated Hospital Sun Yat-Sen University — Гуанчжоу
The Second Affiliated Hospital of Zhejiang University College of Medicine — Ханчжоу
Anhui Provincial Hospital — Хэфэй
Jinhua municipal central hospital — Jinhua
Shandong Jining No.1 People's Hospital — Jining
… и ещё 10 центров

Япония · 18 центров