Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the
screening visit
- Meet the European Alliance of Associations for Rheumatology (EULAR)/American College
of Rheumatology (ACR) 2019 classification criteria for SLE
- One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR
positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central
laboratory at screening
- Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6
points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or
cutaneous vasculitis, and/or rash
- Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry
- At least one SLE background therapy(immunosuppressant and/or antimalarial) is required
for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks
before the screening visit, and must remain stable until randomization and throughout
study participation
- Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted
but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks
before the screening visit, cannot exceed 30 mg/day at screening, and must remain
stable until the Week 4 visit. Participants can be on an OCS as well as an
antimalarial and/or an immunosuppressant
Exclusion Criteria:
- Diagnosis of drug-induced SLE rather than idiopathic SLE
- Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel
disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus,
thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not
excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis,
scleroderma, and mixed connective tissue disease are excluded
- Active or unstable lupus neuropsychiatric manifestations, including, but not limited
to, any condition defined by BILAG A criteria
- Active, severe Class III, and IV, lupus nephritis that requires or may require
treatment with cytotoxic agents or high-dose CS
- History of congenital or acquired immunodeficiency
- Known active infection, or any major episode of infection requiring hospitalization or
treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics
antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or
treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on
any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus,
invasive bacterial or fungal infections, or atypical mycobacteria)
- Taking more than 1 immunosuppressant at screening
- In Japan only: Participants with positive result of ? - D-glucan assay
Other protocol-defined inclusion/exclusion criteria apply
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 4/20/23. Questions regarding updates should be directed to the study team contact.