Phase
Condition
Cutaneous Lupus Erythematosus
Lupus
Musculoskeletal Diseases
Treatment
Tocilizumab
Mosunetuzumab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of SLE according to the 2019 European League Against Rheumatism/AmericanCollege of Rheumatology Classification Criteria at least 12 weeks or more prior toscreening
Presence of one or more of the following SLE autoantibodies documented within the 12months prior to screening or during screening: positive ANA (greater than or equalto 1:160); anti dsDNA above the upper limit of normal (ULN); anti-Sm above the ULN
Active SLE disease, as demonstrated by a SLEDAI-2K total score of greater than orequal to 4 at screening
Current receipt of one or more of the following classes of standard therapies forthe treatment of SLE at stable doses: oral corticosteroids (OCSs), antimalarialagents, conventional immunosuppressants
For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraception as defined by the protocol
For men on mycophenolate mofetil (MMF): With a female partner of childbearingpotential, men who are not surgically sterile must remain abstinent (refrain fromheterosexual intercourse) or use contraception as defined by the protocol
Exclusion
Exclusion Criteria:
Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 3 months after the final dose of mosunetuzumab and 3 months after the finaldose of tocilizumab
Active severe or unstable lupus-associated neuropsychiatric disease that is likelyto require treatment with protocol-prohibited therapies
Active overlap syndrome with mixed connective tissue disease or systemic sclerosiswithin 12 months prior to screening or during screening
Catastrophic or severe antiphospholipid syndrome within 12 months prior to screeningor during screening
Presence of significant lupus-associated renal disease and/or renal impairment thatis likely to require treatment with protocol-prohibited therapies
Peripheral CD19+ B-cell count < 25 cells/uL
Receipt of an investigational therapy within 30 days or 5 drug-eliminationhalf-lives (whichever is longer) prior to initiation of study treatment and duringthe study
Receipt of any of the following excluded therapies: any anti-CD19 or anti-CD20therapy such as blinatumomab, obinutuzumab, rituxumab, ocrelizumab, or ofatumumabless than 12 months prior to screening or during screening; inhibitors of JAK,Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib,upadacitinib, filgotinib, ibrutinib, or fenebrutinib, or any investigational agentwithin 30 days prior to screening or during screening; tacrolimus, ciclosporin, orvoclosporin within 30 day prior to screening or during screening; cyclophosphamideor a biologic therapy such as but not limited to belimumab, ustekinumab,anifrolumab, secukinumab, or atacicept during 2 months prior to screening or duringscreening; any live or attenuated vaccine during 28 days prior to screening orduring screening
High risk for any clinically significant bleeding or any condition requiringplasmapheresis, IV immunoglobulin, or acute blood product transfusions
Significant or uncontrolled medical disease that would preclude participation
HIV infection, acute or chronic hepatitis B virus (HBV), acute or chronic hepatitisC (HCV) infection, tuberculosis (TB) infection, known or suspected chronic activeEpstein-Barr virus (EBV) infection, or cytomegalovirus (CMV) infection
Active infection of any kind, excluding fungal infection of the nail beds
Any major episode of infection that fulfills any of the following criteria: requireshospitalization during 8 weeks prior to screening or during screening; requirestreatment with IV antibiotics (or anti-infective medications) during 8 weeks priorto screening or during screening; requires treatment with oral antibiotics (oranti-infective medications) during 2 weeks prior to screening or during screening
History of serious recurrent or chronic infection
History of progressive multifocal leukoencephalopathy (PML)
History of cancer, including solid tumors, hematological malignancies, and carcinomain situ, within the past 5 years
Major surgery requiring hospitalization during 4 weeks prior to screening or duringscreening or any planned surgery or procedure requiring hospitalization during 12weeks following study drug administration
Current alcohol or drug abuse or history of alcohol or drug abuse within 12 monthsprior to screening or during screening
Intolerance or contraindication to study therapies including history of severeallergic or anaphylactic reactions to monoclonal antibodies or knownhypersensitivity to any component of mosunetuzumab injection
Positive serum human chorionic gonadotropin measures at screening
Any of the following laboratory parameters: aspartate transaminase (AST) or alaninetransaminase (ALT) > 2.5 x upper limit of normal (ULN); total bilirubin > 1.5 x ULN;absolute neutrophil count (ANC) < 2.0 x 10^9/L (< 2000/mm^3); platelet count < 100 x 10^9/L (100,000 mm^3); hemoglobin < 100 g/L (10 g/dL); estimated glomerularfiltration rate (eGFR) < 30 ml/min/1.73 m^2 calculated according to the ChronicKidney Disease Epidemiology Collaboration equation; positive serum human chorionicgonadotropin measured at screening
Study Design
Connect with a study center
LLC ARENSIA Exploratory Medicine
Tbilisi, 0112
GeorgiaSite Not Available
ICS ARENSIA Exploratory Medicine
Chisinau, MD-2025
Moldova, Republic ofSite Not Available
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
PolandSite Not Available
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM
Poznan, 61-545
PolandSite Not Available
Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych
Poznan, 61-545
PolandSite Not Available
Medical Center of Limited Liability Company ?Harmoniya krasy?
Kyiv, KIEV Governorate 01135
UkraineSite Not Available
Pinnacle Research Group
Anniston, Alabama 36207
United StatesSite Not Available
Pinnacle Research Group; Llc, Central
Anniston, Alabama 36207
United StatesSite Not Available
SUNY Upstate Medical University
Syracuse, New York 13210
United StatesSite Not Available
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