A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Exclusion Criteria

• •Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.
• •Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone aceponate) topical corticosteroids within 28 days prior to screening, had dose changes in other topical corticosteroids within 14 days prior to Day 1, or had dose changes in nonsteroidal topical immunosuppressants within 28 days prior to Day 1.
• •Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1.
• •Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \>20 mg/day, abatacept.
• •Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer.
• •Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.
• •Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.
• •Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy.
• •Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection.
• •History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.
• •Active infection or a history of serious infections as defined in the protocol.
• •Surgery within 28 days prior to Day 1.
• •12-lead ECG parameters after 10 minutes resting in supine position NOT in the defined normal ranges.
• •Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study (eg, chronic obstructive pulmonary disease).
• •Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.
• •High dose of antimalarial or a change in dose within 28 days prior to Day 1.
• •Receipt of systemic corticosteroids \>20 mg/day (prednisone or equivalent) or had dose changes of systemic corticosteroids within 28 days prior to Day 1.
• •Documented liver disease including documented diagnosis of cirrhosis.
• •Participants with a history of hypercoagulation event or thrombosis (such as venous thromboembolism, pulmonary embolism, or stroke), or participants who have known hypercoagulation risk factors (including antiphospholipid syndrome), or participants currently on anticoagulation will be excluded.
• •Specific to SLE:
• •* Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis at screening.
• •* Known biopsy-proven diagnosis of lupus nephritis (any class) or otherwise unexplained proteinuria (0.5g protein/24h; or urine protein/creatinine ratio \>0.5g/g) at screening.
• •The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.