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

27. maj 2026 opdateret af: 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).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 40150-150
        • Rekruttering
        • Clnica SER da Bahia
    • Federal District
      • Brasília, Federal District, Brasilien, 70200-730
        • Rekruttering
        • L2IP ?Instituto de Pesquisas Clínicas Ltda.
    • Mato Grosso
      • Cuiab, Mato Grosso, Brasilien, 78020-500
        • Rekruttering
        • IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90480-000
        • Rekruttering
        • LMK Servios Mdicos S/S Ltda
    • Rio de Janeiro
      • Niterói, Rio de Janeiro, Brasilien, 24030-103
        • Rekruttering
        • Complexo Hospitalar de Niteroi
    • São Paulo
      • Ribeiro Preto, São Paulo, Brasilien, 14048-900
        • Rekruttering
        • Hospital das Clinicas de Ribeirao Preto
      • São Paulo, São Paulo, Brasilien, 05403-000
        • Rekruttering
        • Hospital das Clnicas da Faculdade de Medicina da USP
  • Colombia
      • Barranquilla, Colombia, 080020
        • Rekruttering
        • Clinica de la Costa S.A.S
      • Bogotá, Colombia, 110221
        • Rekruttering
        • Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
      • Medellín, Colombia, 050034
        • Rekruttering
        • Hospital Pablo Tobón Uribe
  • Italien
    • Lazio
      • Rome, Lazio, Italien, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Lombardy
      • Brescia, Lombardy, Italien, 25123
        • Rekruttering
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Sydafrika
    • Gauteng
      • Pretoria, Gauteng, Sydafrika, 0002
        • Rekruttering
        • Emmed Research
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7925
        • Rekruttering
        • University of Cape Town Kidney and Hypertension Research Unit
      • Somerset West, Western Cape, Sydafrika, 7130
        • Rekruttering
        • Clinical Trials Network Helderberg

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mosunetuzumab
Participants will receive mosunetuzumab by subcutaneous (SC) injection.
Medicin: Mosunetuzumab
Participants will receive SC mosunetuzumab.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med uønskede hændelser (AE'er)
Tidsramme: Op til 2,5 år
Op til 2,5 år
Serumkoncentration af mosunetuzumab
Tidsramme: Op til 2,5 år
Op til 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. maj 2026

Primær færdiggørelse (Anslået)

28. februar 2028

Studieafslutning (Anslået)

31. august 2028

Datoer for studieregistrering

Først indsendt

2. februar 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Systemisk lupus erythematosus

Kliniske forsøg med Mosunetuzumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Macedonia

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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