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New treatment option for Lupus
Official title A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
ClinicalTrials.gov ID: NCT07598396
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for lupus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR)...
You likely can't join if
- 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...
- Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring...
- 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
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Salvador, Estado de Bahia, Brazil
- Brasília, Federal District, Brazil
- Cuiab, Mato Grosso, Brazil
- Niterói, Rio de Janeiro, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Ribeiro Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Barranquilla, Colombia
- Bogotá, Colombia
- Medellín, Colombia
- Rome, Lazio, Italy
- Brescia, Lombardy, Italy
- Pretoria, Gauteng, South Africa
- Cape Town, Western Cape, South Africa
- Somerset West, Western Cape, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salvador, Estado de Bahia, Brazil; Brasília, Federal District, Brazil; Cuiab, Mato Grosso, Brazil; Niterói, Rio de Janeiro, Brazil; Porto Alegre, Rio Grande do Sul, Brazil; Ribeiro Preto, São Paulo, Brazil and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.