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Lupus drug trial aims for remission without daily pills

NCT ID NCT07598396

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 5 times

Summary

This study tests a drug called mosunetuzumab in 30 people with lupus, a disease where the immune system attacks the body. The goal is to see if the drug can put lupus into remission so that participants can stop most lupus medications for at least 6 months. However, some people may still need low-dose steroids or other treatments long-term, so this is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

lupus erythematosus lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lupus Lupus nephritis Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Administradora Country S.A.S.

    RECRUITING

    Bogotá, 110221, Colombia

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

    RECRUITING

    Brescia, Lombardy, 25123, Italy

  • CIMAB S.A. de C.V.

    RECRUITING

    Torreón, Coahuila, 27000, Mexico

  • Centro Medico del Angel

    RECRUITING

    Mexicali, Estado de Baja California, 21100, Mexico

  • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM

    RECRUITING

    Bogotá, 110221, Colombia

  • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

    RECRUITING

    Culiacán, Sinaloa, 80000, Mexico

  • Centro de Investigación y Tratamiento Reumatológico S.C.

    RECRUITING

    México, Mexico CITY (federal District), 11850, Mexico

  • Clinica de la Costa S.A.S

    RECRUITING

    Barranquilla, 080020, Colombia

  • Clinical Trials Network Helderberg

    RECRUITING

    Somerset West, Western Cape, 7130, South Africa

  • Clnica SER da Bahia

    RECRUITING

    Salvador, Estado de Bahia, 40150-150, Brazil

  • Complexo Hospitalar de Niteroi

    RECRUITING

    Niterói, Rio de Janeiro, 24030-103, Brazil

  • Emmed Research

    RECRUITING

    Pretoria, Gauteng, 0002, South Africa

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, 00168, Italy

  • Hospital Pablo Tobon Uribe

    RECRUITING

    Medellín, 050034, Colombia

  • Hospital das Clinicas de Ribeirao Preto

    RECRUITING

    Ribeiro Preto, São Paulo, 14048-900, Brazil

  • Hospital das Clnicas da Faculdade de Medicina da USP

    RECRUITING

    São Paulo, São Paulo, 05403-000, Brazil

  • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso

    RECRUITING

    Cuiab, Mato Grosso, 78020-500, Brazil

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, 20089, Italy

  • L2IP ?Instituto de Pesquisas Clínicas Ltda.

    RECRUITING

    Brasília, Federal District, 70200-730, Brazil

  • LMK Servios Mdicos S/S Ltda

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

  • University of Cape Town Kidney and Hypertension Research Unit

    RECRUITING

    Cape Town, Western Cape, 7925, South Africa

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