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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive SC mosunetuzumab.
Clnica SER da Bahia
Salvador, Estado de Bahia, Brazil
RECRUITINGProportion 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.
Time frame: Up to Week 76
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.
Time frame: 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.
Time frame: 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.
Time frame: Weeks 24, 52, 76, and 104
Percentage of participants with adverse events (AEs)
Time frame: Up to 2.5 years
Reference Study ID Number: GA45799 https://forpatients.roche.com/
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L2IP ?Instituto de Pesquisas Clínicas Ltda.
Brasília, Federal District, Brazil
IPC MT Instituto de Pesquisas Clinicas do Mato Grosso
Cuiab, Mato Grosso, Brazil
RECRUITINGComplexo Hospitalar de Niteroi
Niterói, Rio de Janeiro, Brazil
RECRUITINGLMK Servios Mdicos S/S Ltda
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGHospital das Clinicas de Ribeirao Preto
Ribeiro Preto, São Paulo, Brazil
RECRUITINGHospital das Clnicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
RECRUITINGClinica de la Costa S.A.S
Barranquilla, Colombia
RECRUITINGCentro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
Bogotá, Colombia
RECRUITINGHospital Pablo Tobon Uribe
Medellín, Colombia
RECRUITING...and 5 more locations
Longitudinal change in titers of anti-double-stranded (ds) DNA
Time frame: Up to 2.5 years
Longitudinal changes in complement C3 and C4
Time frame: Up to 2.5 years
Serum concentration of mosunetuzumab
Time frame: Up to 2.5 years
Percentage of participants with anti-drug antibodies (ADAs)
Time frame: Baseline up to 2.5 years
CD19+ absolute counts in blood
Time frame: Up to 2.5 years
Change in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue
Time frame: Baseline to Week 76
Change in Subject's Global Assessment of Disease Activity (SGA)
Time frame: Baseline to Week 76