A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

Официальное название

A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis

Обзор

This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).

Вмешательства

• Препарат Mosunetuzumab
  Participants will receive SC mosunetuzumab.

Первичные конечные точки

• Proportion of participants who have achieved remission by Week 76 [Срок оценки: Up to Week 76]

Вторичные конечные точки (11)

• Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76 [Срок оценки: Up to Week 76]
• Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104 [Срок оценки: Weeks 24, 52, 76, and 104]
• Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104 [Срок оценки: Weeks 24, 52, 76, and 104]
• Percentage of participants with adverse events (AEs) [Срок оценки: Up to 2.5 years]
• Longitudinal change in titers of anti-double-stranded (ds) DNA [Срок оценки: Up to 2.5 years]
• Longitudinal changes in complement C3 and C4 [Срок оценки: Up to 2.5 years]
• Serum concentration of mosunetuzumab [Срок оценки: Up to 2.5 years]
• Percentage of participants with anti-drug antibodies (ADAs) [Срок оценки: Baseline up to 2.5 years]
• CD19+ absolute counts in blood [Срок оценки: Up to 2.5 years]
• Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue [Срок оценки: Baseline to Week 76]
• Change in Subject's Global Assessment of Disease Activity (SGA) [Срок оценки: Baseline to Week 76]

Критерии участия

Критерии включения

• Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria at screening

Критерии исключения

• Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
• Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study
• Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration
• Alcohol or substance abuse within the 12 months prior to screening
• Active infection of any kind, excluding fungal infection of the nail beds
• Any major episode of infection as defined by the protocol
• History of serious recurrent or chronic infection
• History of progressive multifocal leukoencephalopathy (PML)
• Tuberculosis (TB) infection
• History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years
• Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening
• Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable
• High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions
• Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex
• History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1
• History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years
• Receipt of any live or attenuated vaccine in the 28 days prior to or during screening

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бразилия · 7 центров

• Clnica SER da Bahia — Salvador
• L2IP ?Instituto de Pesquisas Clínicas Ltda. — Brasília
• IPC MT Instituto de Pesquisas Clinicas do Mato Grosso — Cuiab
• Complexo Hospitalar de Niteroi — Niterói
• LMK Servios Mdicos S/S Ltda — Porto Alegre
• Hospital das Clinicas de Ribeirao Preto — Ribeiro Preto
• Hospital das Clnicas da Faculdade de Medicina da USP — São Paulo

Колумбия · 3 центра

• Clinica de la Costa S.A.S — Barranquilla
• Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM — Bogotá
• Hospital Pablo Tobon Uribe — Medellín

ЮАР · 3 центра

• Emmed Research — Pretoria
• University of Cape Town Kidney and Hypertension Research Unit — Cape Town
• Clinical Trials Network Helderberg — Somerset West

Италия · 2 центра

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civ — Brescia

Мексика · 2 центра

• Centro Medico del Angel — Mexicali
• Centro de Investigación y Tratamiento Reumatológico S.C. — México

Публикации

• Martins E, Chindalore VL, Sheng XR, Schroeder AV, Chen V, Mody H, Arjomandi A, Mao HA, Hassan I, Dankiewicz-Fares I, Agachi S, Omachi TA, Garg JP, Pendergraft WF 3rd. Phase Ib, multicentre, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered mosunetuzumab in participants with systemic lupus erythematosus. Lupu PMID 42309556

Идентификаторы

NCT: NCT07598396 · GA45799 · 2024-519930-22-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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