Mosunetuzumab for people with systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial evaluates mosunetuzumab in adults diagnosed with SLE by the 2019 EULAR/ACR criteria, including those with or without active lupus nephritis. Participants will receive mosunetuzumab as the investigational therapy, with eligibility excluding certain conditions such as recent pregnancy, recent other investigational therapy, major surgery, active infections, and other specified health factors. The study aims to characterize safety and the biological activity of mosunetuzumab in this patient population. Sites are located in Argentina, including Buenos Aires and Salvador, with Hoffmann-La Roche as lead sponsor. The trial does not list a comparator and is focused on assessing the intervention's effects in real-world diverse SLE patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Organizacion Medica de Investigacion (OMI)
  Caba, Buenos Aires, Argentina Recruiting
• APRILLUS Asistencia e Investigacion
  Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina Recruiting
• Clnica SER da Bahia
  Salvador, Estado de Bahia, Brazil Recruiting
• L2IP ?Instituto de Pesquisas Clínicas Ltda.
  Brasília, Federal District, Brazil Recruiting
• IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
  Cuiab, Mato Grosso, Brazil Recruiting
• Complexo Hospitalar de Niteroi
  Niterói, Rio de Janeiro, Brazil Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: GA45799 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.