A Study of Imvotamab in Severe Systemic Lupus Erythematosus

Inclusion Criteria

• •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.