A Study of Imvotamab in Severe Systemic Lupus Erythematosus

About the study

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Key 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.

EXCLUSION CRITERIA

Key Exclusion Criteria:

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.