A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Phase 3

Recruiting

• Conditions: M329 Systemic lupus erythematosus, unspecified; Systemic lupus erythematosus, unspecified; M329

• Registration Number: PER-021-21
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-30
• Study Completion: 2021-12-28
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: In enrollment
• Sex: All
• Target Recruitment: 112

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

- 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified