LupusPhase 2SOLUNANCT07598396
A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
A Phase 2 study testing Mosunetuzumab in people with Lupus and Systemic Lupus Erythematosus, run by Hoffmann-La Roche at 24 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus, Systemic Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- Mosunetuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 24 sitesin 6 countries
- Study dates
- 25 May 2026to 31 Aug 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
24 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GA45799 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
24 sites in 6 countries
Brazil7 sites, 7 recruiting
- Recruiting
L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, 70200-730
- Recruiting
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab, Mato Grosso, 78020-500
- Recruiting
Complexo Hospitalar de Niteroi
Niterói, Rio de Janeiro, 24030-103
- Recruiting
LMK Servios Mdicos S/S Ltda
Porto Alegre, Rio Grande do Sul, 90480-000
- Recruiting
Hospital das Clinicas de Ribeirao Preto
Ribeiro Preto, São Paulo, 14048-900
- Recruiting
Clnica SER da Bahia
Salvador, Estado de Bahia, 40150-150
- Recruiting
Hospital das Clnicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-000
Mexico5 sites, 5 recruiting
- Recruiting
Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
Culiacán, Sinaloa, 80000
- Recruiting
CREA de Guadalajara, S.C.
Guadalajara, Jalisco, 44100
- Recruiting
Centro Medico del Angel
Mexicali, Estado de Baja California, 21100
- Recruiting
Centro de Investigación y Tratamiento Reumatológico S.C.
México, Mexico CITY (federal District), 11850
- Recruiting
CIMAB S.A. de C.V.
Torreón, Coahuila, 27000
Colombia4 sites, 4 recruiting
- Recruiting
Clinica de la Costa S.A.S
Barranquilla, 080020
- Recruiting
Administradora Country S.A.S.
Bogotá, 110221
- Recruiting
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, 110221
- Recruiting
Hospital Pablo Tobon Uribe
Medellín, 050034
Italy3 sites, 3 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia, Lombardy, 25123
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
- Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
South Africa3 sites, 3 recruiting
- Recruiting
University of Cape Town Kidney and Hypertension Research Unit
Cape Town, Western Cape, 7925
- Recruiting
Emmed Research
Pretoria, Gauteng, 0002
- Recruiting
Clinical Trials Network Helderberg
Somerset West, Western Cape, 7130
Argentina2 sites, 2 recruiting
- Recruiting
APRILLUS Asistencia e Investigacion
Buenos Aires, Ciudad Autonoma Buenos Aires, 1406
- Recruiting
Organizacion Medica de Investigacion (OMI)
CABA, Buenos Aires, C1015ABO
About this study
Official title: 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
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).
- Conditions
- Lupus, Systemic Lupus Erythematosus, Lupus Nephritis
- Being tested
- Mosunetuzumab
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosunetuzumabDrug
Participants will receive SC mosunetuzumab.
| Study group | Role | What they receive |
|---|---|---|
| Mosunetuzumab | Experimental | Participants will receive mosunetuzumab by subcutaneous (SC) injection. Receives: Drug: Mosunetuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who have achieved remission by 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.
Measured: Up to Week 76
Secondary outcomes (11)
Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76
DORIS remission is defined as achievement of all of the following for at least 6 months: Clinical systemic lupus erythematosus disease activity index (cSLEDAI) = 0 after completion of mosunetuzumab treatment; stable dosing of SLE therapies for at least 6 months; Physician Global Assessment (PGA) of < 0.5, and; prednisone (or equivalent) dose ≤5 mg/day.
Measured: Up to Week 76
Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104
CRR is defined as all of the following: Urinary protein-to-creatinine ratio (UPCR) < 0.5 g/g, and; estimated glomerular filtration rate (eGFR) ≥ 85% of baseline, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or ≥ 60 ml/min per 1.73 m^2 of body-surface area.
Measured: Weeks 24, 52, 76, and 104
Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104
PRR is defined as all of the following: ≥ 50% reduction in UPCR from baseline; UPCR < 1 g/g (or < 3 g/g if the baseline UPCR was ≥ 3 g/g), and; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation.
Measured: Weeks 24, 52, 76, and 104
Percentage of participants with adverse events (AEs)
Measured: Up to 2.5 years
Longitudinal change in titers of anti-double-stranded (ds) DNA
Measured: Up to 2.5 years
Longitudinal changes in complement C3 and C4
Measured: Up to 2.5 years
Serum concentration of mosunetuzumab
Measured: Up to 2.5 years
Percentage of participants with anti-drug antibodies (ADAs)
Measured: Baseline up to 2.5 years
CD19+ absolute counts in blood
Measured: Up to 2.5 years
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue
Measured: Baseline to Week 76
Change in Subject's Global Assessment of Disease Activity (SGA)
Measured: Baseline to Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start25 May 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LupusStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598396
- Sponsor's protocol ID
- GA45799
- Other IDs
- 2024-519930-22-00
- Acronym
- SOLUNA
- Status last verified
- Oct 2026
- First submitted
- 2 Feb 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Publications
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. Lupus Sci Med. 2026 Jun 17;13(1):e002019. doi: 10.1136/lupus-2026-002019.
PubMed 42309556