M329 Systemic lupus erythematosus, unspecified Systemic lupus erythematosus, unspecified
Conditions
Interventions
Treatments: Placebo (corresponding to the obinutuzumab 1000-mg dose) receive blinded infusions of placebo placebo on Day 1 and Weeks 2, 24, and 26. - Treatments: Obinutuzumab 1000 mg IV infusion at Da
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: - Participants who are capable of giving signed informed consent - Participants who are age 18-75 years at the time of signing Informed Consent Form - Ability to comply with the study protocol, in the investigator's judgment - Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria - 12 weeks prior to screening. - ANA >= 1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN), as determined by the central laboratory at screening - Low C3, C4, and/or CH50 as determined by the central laboratory at screening - High disease activity at screening - High disease activity on Day 1, - Current receipt of >=1 of the following classes of standard therapies for the treatment of SLE at stable doses: OCS, antimalarials, conventional immunosuppressants
Exclusion criteria
Exclusion criteria: - Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 18 months after the final dose of obinutuzumab or placebo - Presence of significant lupus-associated renal disease and/or renal impairment - Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator - Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within 12 months prior to screening or during screening - Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening - History of non-SLE inflammatory skin or joint disease within one year of Day 1 that, in the opinion of the investigator, could interfere with assessments of skin or joint manifestations of SLE - History of any non-SLE disease treated with oral, IV, or IM corticosteroids for more than 14 days in total during the one year prior to Day 1 - Receipt of any of the following excluded therapies: Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy, Cyclophosphamide, tacrolimus, ciclosporin, or voclosporin during the 2 months prior to screening or during screening, Any biologic therapy (other than anti-CD20, anti-CD19, or anti-plasma cell), Inhibitors of Janus-associated kinase (JAK), Bruton’s tyrosine kinase (BTK), or tyrosine kinase 2 (TYK2), Any live vaccine during the 28 days prior to screening. - High risk for clinically significant bleeding - Significant or uncontrolled medical disease - HIV infection - Tuberculosis (TB) infection - Active infection of any kind, excluding fungal infection of the nail beds - Any major episode of infection - History of serious recurrent or chronic infection - History of progressive multifocal leukoencephalopathy (PML) - History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years - Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening - Current alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening or during screening - Intolerance or contraindication to study therapies - Any of the following laboratory parameters (AST or ALT >2.5xULN, Neutrophils <1.5x103/µL, positive hepatitis B surface antigen (HBsAg, positive hepatitis C serology, Hemoglobin < 7 g/dL, unless due to active to SLE, platelet count <50,000/µL, unless due to active SLE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SRI(4) is defined as achievement of all of the following: - Reduction from baseline of = 4 points in the SLEDAI-2K - No new systems or organs affected, as defined by =1 new BILAG A or =2 new BILAG B items compared with baseline using BILAG-2004 - No worsening from baseline of =0.30 points on a 3-point PGA-VAS NAME OF THE RESULT: Proportion of participants who achieve SRI(4) (Systemic Lupus Erythematosus Responder Index) at Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Time from baseline to Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-36 v2 Physical Component Summary scale NAME OF THE RESULT: Change in SF-36 v2 Physical Component Summary scale from baseline to Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: from baseline to Week 52;SF-36 v2 Bodily Pain NAME OF THE RESULT: Change in SF-36 v2 Bodily Pain domain scale from baseline to Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From baseline to Week 52;FACIT-F scale NAME OF THE RESULT: Change in FACIT-F scale from baseline to Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From baseline to Week 52;LLDAS is defined as achievement of all of the following: - SLEDAI-2K = 4 -No SLEDAI-2K activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, fever) and no BILAG hemolytic anemia or gastrointestinal activity - No new SLEDAI-2K activity compared with the previous assessment - PGA-VAS =1 -Current prednisone dose = 7.5 mg/day (or equivalent) NAME OF THE RESULT: Proportion of participants who achieve LLDAS at Week 52 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At Week 52;SRI(4) is defined as achievement of all of the following: - Reduction from baseline of = 4 points in the SLEDAI-2K - No new systems or organs affected, as defined by =1 new BILAG A or =2 new BILAG B items compared with baseline using BILAG-2004 - No worsening from baseline of =0.30 points on a 3-point PGA-VAS NAME OF THE RESULT: Proportion of participants who achieve SRI(4) at Week 52 on low-dose corticosteroids, defined as prednisone =5 mg/day (or equivalent) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At Week 52;SRI(4) is defined as achievement of all of the following: - Reduction from baseline of = 4 points in the SLEDAI-2K - No new systems or organs aff | — |
Countries
Argentina, Brazil, France, Italy, Mexico, Peru, Poland, Russian Federation, South Africa, Spain, United Kindgdom, United States
Contacts
Public ContactLIZETH MABEL PEREZ
ROCHE FARMA (PERU) S.A.
Outcome results
None listed