Mosunetuzumab: Participants will receive SC mosunetuzumab.
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Proportion of participants who have achieved remission by Week 76 — Up to Week 76 Drug-Free Remission is defined as achieving both of the following: Absence of disease activity maintained for 6 months after completion of mosunetuzumab treatment, and; not receiving any SLE-directed therapy (except for antimalarials) during the 6 months. Doses of prednisone (or equivalent) ≤5 mg/day to treat secondary adrenal insufficiency are permitted.
Trial sites (22)
Facility
City
Region
Status
Clnica SER da Bahia
Salvador
Estado de Bahia
Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília
Federal District
Recruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab
Mato Grosso
Recruiting
Complexo Hospitalar de Niteroi
Niterói
Rio de Janeiro
Recruiting
LMK Servios Mdicos S/S Ltda
Porto Alegre
Rio Grande do Sul
Recruiting
Hospital das Clinicas de Ribeirao Preto
Ribeiro Preto
São Paulo
Recruiting
Hospital das Clnicas da Faculdade de Medicina da USP
São Paulo
São Paulo
Recruiting
Clinica de la Costa S.A.S
Barranquilla
Colombia
Recruiting
Administradora Country S.A.S.
Bogotá
Colombia
Recruiting
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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