Lead Sponsor

IGM Biosciences, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Age ≥ 18 years at the time of signing ICF
•Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
•Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
•Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
•It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.

•Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
•Any lupus-associated neuropsychiatric disease.
•Active lupus nephritis with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
•Prednisone-equivalent \> 30 mg/day, including immediate and extended-release oral formulations.
•Drug-induced lupus.
•Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.