The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s). The total duration of the clinical trial for each participant will be up to approximately 9 to 12 months.
Estimated glomerular filtration rate (eGFR) >30 milliliters/minute/1.73 square meters (mL/min/1.73 m²) at the screening visit.
Participant has a confirmed diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology SLE classification criteria ≥ 24 weeks prior to signing the informed consent form (ICF).
Current scalp involvement between 25% and 95%, inclusive (Severity of Alopecia Tool [SALT] score between 25 and 95, inclusive), at screening.
Current episode of AA is of duration > 24 weeks (without evidence of spontaneous terminal hair regrowth at the time of screening and first treatment, i.e., no more than 10% regrowth), but ≤ 5 years from onset of current episode of severe scalp hair loss.
Receipt of high-dose corticosteroid therapy within 4 weeks prior to screening as either (a) intravenous (IV) pulse corticosteroid therapy or (b) daily oral corticosteroid therapy of ≥ 1 milligrams per kilogram (mg/kg) or up to 40 milligrams per day (mg/day) prednisone (or equivalent).
Receipt of blood products within 6 months prior to screening.
Previous exposure to VIS171 or any other drug targeting interleukins (IL)-2 or the IL-2 receptor or T regulatory cells.
History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome (APS) within 1 year prior to signing ICF. SLE participants with APS adequately controlled by anticoagulant are eligible. SLE participants who are found to be triple positive for anti-phospholipid antibodies at screening (without clinical APS) will be excluded unless they are on stable anti-thrombotic therapy.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lead sponsor