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A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis (SOLUNA)

20. august 2026 oppdatert av: Hoffmann-La Roche

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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Studer Kontakt Backup

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

Studiesteder

  • Brasil
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasil, 40150-150
        • Rekruttering
        • Clnica SER da Bahia
    • Federal District
      • Brasília, Federal District, Brasil, 70200-730
        • Rekruttering
        • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • Mato Grosso
      • Cuiab, Mato Grosso, Brasil, 78020-500
        • Rekruttering
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90480-000
        • Rekruttering
        • LMK Servios Mdicos S/S Ltda
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brasil, 24030-103
        • Rekruttering
        • Complexo Hospitalar de Niteroi
    • São Paulo
      • Ribeiro Preto, São Paulo, Brasil, 14048-900
        • Rekruttering
        • Hospital das Clinicas de Ribeirao Preto
      • São Paulo, São Paulo, Brasil, 05403-000
        • Rekruttering
        • Hospital das Clnicas da Faculdade de Medicina da USP
  • Colombia
      • Barranquilla, Colombia, 080020
        • Rekruttering
        • Clínica de la Costa S.A.S
      • Bogotá, Colombia, 110221
        • Rekruttering
        • Administradora Country S.A.S.
      • Bogotá, Colombia, 110221
        • Rekruttering
        • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
      • Medellín, Colombia, 050034
        • Rekruttering
        • Hospital Pablo Tobon Uribe
  • Italia
    • Lazio
      • Rome, Lazio, Italia, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Brescia, Lombardy, Italia, 25123
        • Rekruttering
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Rozzano, Lombardy, Italia, 20089
        • Rekruttering
        • Istituto Clinico Humanitas
  • Mexico
    • Coahuila
      • Torreón, Coahuila, Mexico, 27000
        • Rekruttering
        • CIMAB S.A. de C.V.
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21100
        • Rekruttering
        • Centro Medico del Angel
    • Mexico CITY (federal District)
      • México, Mexico CITY (federal District), Mexico, 11850
        • Rekruttering
        • Centro de Investigación y Tratamiento Reumatológico S.C.
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80000
        • Rekruttering
        • Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)
  • Sør-Afrika
    • Gauteng
      • Pretoria, Gauteng, Sør-Afrika, 0002
        • Rekruttering
        • Emmed Research
    • Western Cape
      • Cape Town, Western Cape, Sør-Afrika, 7925
        • Rekruttering
        • University of Cape Town Kidney and Hypertension Research Unit
      • Somerset West, Western Cape, Sør-Afrika, 7130
        • Rekruttering
        • Clinical Trials Network Helderberg

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Mosunetuzumab
Participants will receive mosunetuzumab by subcutaneous (SC) injection.
Legemiddel: Mosunetuzumab
Participants will receive SC mosunetuzumab.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of participants who have achieved remission by Week 76
Tidsramme: 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.
Up to Week 76

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Andel deltakere med uønskede hendelser (AE)
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Serumkonsentrasjon av mosunetuzumab
Tidsramme: Inntil 2,5 år
Inntil 2,5 år
Proportion of participants who achieve Definition of Remission in SLE (DORIS) by Week 76
Tidsramme: Up to 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.
Up to Week 76
Proportion of participants who achieve Complete Renal Response (CRR) at Weeks 24, 52, 76, and 104
Tidsramme: 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.
Weeks 24, 52, 76, and 104
Proportion of participants who achieve Partial Renal Response (PRR) at Weeks 24, 52, 76, and 104
Tidsramme: 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.
Weeks 24, 52, 76, and 104
Longitudinal change in titers of anti-double-stranded (ds) DNA
Tidsramme: Up to 2.5 years
Up to 2.5 years
Longitudinal changes in complement C3 and C4
Tidsramme: Up to 2.5 years
Up to 2.5 years
Percentage of participants with anti-drug antibodies (ADAs)
Tidsramme: Baseline up to 2.5 years
Baseline up to 2.5 years
CD19+ absolute counts in blood
Tidsramme: Up to 2.5 years
Up to 2.5 years
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue
Tidsramme: Baseline to Week 76
Baseline to Week 76
Change in Subject's Global Assessment of Disease Activity (SGA)
Tidsramme: Baseline to Week 76
Baseline to Week 76

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hoffmann-La Roche

Etterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. mai 2026

Primær fullføring (Antatt)

28. februar 2028

Studiet fullført (Antatt)

31. august 2028

Datoer for studieregistrering

Først innsendt

2. februar 2026

Først innsendt som oppfylte QC-kriteriene

14. mai 2026

Først lagt ut (Faktiske)

20. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GA45799
  • 2024-519930-22-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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