[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640944":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":26,"studyPopulation":26,"armGroups":50,"interventions":57,"overallOfficials":62,"centralContacts":66,"locations":74,"responsibleParty":275,"collaborators":26,"id":277,"slug":278,"hasResults":279,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":279,"sex":285,"minAge":286,"maxAge":26,"enrollmentInfo":287,"targetDuration":26,"studyType":290,"phases":291,"briefSummary":293,"conditions":294,"keywords":26,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":307},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fday to treat secondary adrenal insufficiency are permitted.","Up to Week 76",[14,17,21,24,28,30,32,34,37,39,42],{"measure":15,"description":16,"timeFrame":12},"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 \\\u003C 0.5, and; prednisone (or equivalent) dose ≤5 mg\u002Fday.",{"measure":18,"description":19,"timeFrame":20},"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) \\\u003C 0.5 g\u002Fg, and; estimated glomerular filtration rate (eGFR) ≥ 85% of baseline, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or ≥ 60 ml\u002Fmin per 1.73 m\\^2 of body-surface area.","Weeks 24, 52, 76, and 104",{"measure":22,"description":23,"timeFrame":20},"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 \\\u003C 1 g\u002Fg (or \\\u003C 3 g\u002Fg if the baseline UPCR was ≥ 3 g\u002Fg), and; eGFR ≥85% of baseline, as calculated using the CKD-EPI equation.",{"measure":25,"description":26,"timeFrame":27},"Percentage of participants with adverse events (AEs)",null,"Up to 2.5 years",{"measure":29,"description":26,"timeFrame":27},"Longitudinal change in titers of anti-double-stranded (ds) DNA",{"measure":31,"description":26,"timeFrame":27},"Longitudinal changes in complement C3 and C4",{"measure":33,"description":26,"timeFrame":27},"Serum concentration of mosunetuzumab",{"measure":35,"description":26,"timeFrame":36},"Percentage of participants with anti-drug antibodies (ADAs)","Baseline up to 2.5 years",{"measure":38,"description":26,"timeFrame":27},"CD19+ absolute counts in blood",{"measure":40,"description":26,"timeFrame":41},"Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue","Baseline to Week 76",{"measure":43,"description":26,"timeFrame":41},"Change in Subject's Global Assessment of Disease Activity (SGA)",{"allocation":45,"interventionModel":46,"interventionModelDescription":26,"primaryPurpose":47,"observationalModel":26,"timePerspective":26,"maskingInfo":48},"NA","SINGLE_GROUP","TREATMENT",{"masking":49,"maskingDescription":26,"whoMasked":26},"NONE",[51],{"label":52,"type":53,"description":54,"interventionNames":55},"Mosunetuzumab","EXPERIMENTAL","Participants will receive mosunetuzumab by subcutaneous (SC) injection.",[56],"Drug: Mosunetuzumab",[58],{"type":59,"name":52,"description":60,"armGroupLabels":61,"otherNames":26},"DRUG","Participants will receive SC mosunetuzumab.",[52],[63],{"name":64,"affiliation":5,"role":65},"Clinical Trials","STUDY_DIRECTOR",[67,72],{"name":68,"role":69,"phone":70,"phoneExt":26,"email":71},"Reference Study ID Number: GA45799 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. Only)","global-roche-genentech-trials@gene.com",{"name":73,"role":69,"phone":26,"phoneExt":26,"email":26},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[75,89,99,104,114,124,129,137,148,157,162,171,183,193,202,214,224,234,244,256,266],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":26},"Clnica SER da Bahia","RECRUITING","Salvador","Estado de Bahia","40150-150","Brazil","BR",{"type":84,"coordinates":85},"Point",[86,87],-38.49096,-12.97563,{"lat":87,"lon":86},{"facility":90,"status":77,"city":91,"state":92,"zip":93,"country":81,"countryCode":82,"cosmosGeoPoint":94,"geoPoint":98,"contacts":26},"L2IP ?Instituto de Pesquisas Clínicas Ltda.","Brasília","Federal District","70200-730",{"type":84,"coordinates":95},[96,97],-47.92972,-15.77972,{"lat":97,"lon":96},{"facility":100,"status":77,"city":101,"state":102,"zip":103,"country":81,"countryCode":82,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"IPC MT Instituto de Pesquisas Clinicas do Mato Grosso","Cuiab","Mato Grosso","78020-500",{"facility":105,"status":77,"city":106,"state":107,"zip":108,"country":81,"countryCode":82,"cosmosGeoPoint":109,"geoPoint":113,"contacts":26},"Complexo Hospitalar de Niteroi","Niterói","Rio de Janeiro","24030-103",{"type":84,"coordinates":110},[111,112],-43.10361,-22.88333,{"lat":112,"lon":111},{"facility":115,"status":77,"city":116,"state":117,"zip":118,"country":81,"countryCode":82,"cosmosGeoPoint":119,"geoPoint":123,"contacts":26},"LMK Servios Mdicos S\u002FS Ltda","Porto Alegre","Rio Grande do Sul","90480-000",{"type":84,"coordinates":120},[121,122],-51.23019,-30.03283,{"lat":122,"lon":121},{"facility":125,"status":77,"city":126,"state":127,"zip":128,"country":81,"countryCode":82,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Hospital das Clinicas de Ribeirao Preto","Ribeiro Preto","São Paulo","14048-900",{"facility":130,"status":77,"city":127,"state":127,"zip":131,"country":81,"countryCode":82,"cosmosGeoPoint":132,"geoPoint":136,"contacts":26},"Hospital das Clnicas da Faculdade de Medicina da USP","05403-000",{"type":84,"coordinates":133},[134,135],-46.63611,-23.5475,{"lat":135,"lon":134},{"facility":138,"status":77,"city":139,"state":26,"zip":140,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":26},"Clinica de la Costa S.A.S","Barranquilla","080020","Colombia","CO",{"type":84,"coordinates":144},[145,146],-74.78132,10.96854,{"lat":146,"lon":145},{"facility":149,"status":77,"city":150,"state":26,"zip":151,"country":141,"countryCode":142,"cosmosGeoPoint":152,"geoPoint":156,"contacts":26},"Administradora Country S.A.S.","Bogotá","110221",{"type":84,"coordinates":153},[154,155],-74.08175,4.60971,{"lat":155,"lon":154},{"facility":158,"status":77,"city":150,"state":26,"zip":151,"country":141,"countryCode":142,"cosmosGeoPoint":159,"geoPoint":161,"contacts":26},"Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM",{"type":84,"coordinates":160},[154,155],{"lat":155,"lon":154},{"facility":163,"status":77,"city":164,"state":26,"zip":165,"country":141,"countryCode":142,"cosmosGeoPoint":166,"geoPoint":170,"contacts":26},"Hospital Pablo Tobon Uribe","Medellín","050034",{"type":84,"coordinates":167},[168,169],-75.57151,6.245,{"lat":169,"lon":168},{"facility":172,"status":77,"city":173,"state":174,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":26},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Rome","Lazio","00168","Italy","IT",{"type":84,"coordinates":179},[180,181],12.51133,41.89193,{"lat":181,"lon":180},{"facility":184,"status":77,"city":185,"state":186,"zip":187,"country":176,"countryCode":177,"cosmosGeoPoint":188,"geoPoint":192,"contacts":26},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)","Brescia","Lombardy","25123",{"type":84,"coordinates":189},[190,191],10.21472,45.53558,{"lat":191,"lon":190},{"facility":194,"status":77,"city":195,"state":186,"zip":196,"country":176,"countryCode":177,"cosmosGeoPoint":197,"geoPoint":201,"contacts":26},"Istituto Clinico Humanitas","Rozzano","20089",{"type":84,"coordinates":198},[199,200],9.1559,45.38193,{"lat":200,"lon":199},{"facility":203,"status":77,"city":204,"state":205,"zip":206,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":26},"CIMAB S.A. de C.V.","Torreón","Coahuila","27000","Mexico","MX",{"type":84,"coordinates":210},[211,212],-103.41898,25.54389,{"lat":212,"lon":211},{"facility":215,"status":77,"city":216,"state":217,"zip":218,"country":207,"countryCode":208,"cosmosGeoPoint":219,"geoPoint":223,"contacts":26},"Centro Medico del Angel","Mexicali","Estado de Baja California","21100",{"type":84,"coordinates":220},[221,222],-115.45446,32.62781,{"lat":222,"lon":221},{"facility":225,"status":77,"city":226,"state":227,"zip":228,"country":207,"countryCode":208,"cosmosGeoPoint":229,"geoPoint":233,"contacts":26},"Centro de Investigación y Tratamiento Reumatológico S.C.","México","Mexico CITY (federal District)","11850",{"type":84,"coordinates":230},[231,232],-109.02397,25.80426,{"lat":232,"lon":231},{"facility":235,"status":77,"city":236,"state":237,"zip":238,"country":207,"countryCode":208,"cosmosGeoPoint":239,"geoPoint":243,"contacts":26},"Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)","Culiacán","Sinaloa","80000",{"type":84,"coordinates":240},[241,242],-107.39421,24.80209,{"lat":242,"lon":241},{"facility":245,"status":77,"city":246,"state":247,"zip":248,"country":249,"countryCode":250,"cosmosGeoPoint":251,"geoPoint":255,"contacts":26},"Emmed Research","Pretoria","Gauteng","0002","South Africa","ZA",{"type":84,"coordinates":252},[253,254],28.18783,-25.74486,{"lat":254,"lon":253},{"facility":257,"status":77,"city":258,"state":259,"zip":260,"country":249,"countryCode":250,"cosmosGeoPoint":261,"geoPoint":265,"contacts":26},"University of Cape Town Kidney and Hypertension Research Unit","Cape Town","Western Cape","7925",{"type":84,"coordinates":262},[263,264],18.42322,-33.92584,{"lat":264,"lon":263},{"facility":267,"status":77,"city":268,"state":259,"zip":269,"country":249,"countryCode":250,"cosmosGeoPoint":270,"geoPoint":274,"contacts":26},"Clinical Trials Network Helderberg","Somerset West","7130",{"type":84,"coordinates":271},[272,273],18.82113,-34.08401,{"lat":273,"lon":272},{"type":276,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100640944","phase-2-a-study-to-evaluate-mosunetuzumab-in-participants-with-systemic-lupus-erythematosus-with-or-without-active-lupus-nephritis-100640944",false,"NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","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","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* 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\n* 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\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* 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\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* 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\n* 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\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening","ALL","18 Years",{"count":288,"type":289},30,"ESTIMATED","INTERVENTIONAL",[292],"PHASE2","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).",[295,296,297],"Lupus","Systemic Lupus Erythematosus","Lupus Nephritis","2026-08-20",{"date":300,"type":301},"2026-08-21","ACTUAL",{"date":303,"type":301},"2026-05-25",{"date":305,"type":289},"2028-08-31",{"name":5,"class":6},21]