A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases

Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

Inclusion criteria

• Male or female ≥ 18 years of age and ≤ 60 years of age and a body mass index (BMI) < 30 kg/m² or, in patients who have completed dosing with a vaccine against COVID-19 and are at least 1 month post the last dose, ≤ 65 years of age and BMI < 35 kg/m^2
• A diagnosis of one of a specified list of rheumatologic diseases at least 6 months prior to screening.
• Stable dosing (or no use) of glucocorticoid or disease-modifying antirheumatic drugs (DMARDs) used for treatment of rheumatologic disease for ≥ 28 days prior to randomization.
• Willing to practice study-required contraception.

Exclusion criteria

• Planning to change treatment for rheumatologic disorder within 4 months after randomization
• Known immunodeficiency disorder or history of splenectomy, organ or cell-based transplantation, total lymphoid irradiation or T-cell vaccination or transfusion in prior 6 months
• Treatment with prednisone or equivalent at a dose > 10 mg/day or intraarticular, intravenous or intramuscular steroids within 28 days prior to screening
• Treatment with any of the following medications within 28 days prior to screening (unless otherwise specified below) above the given doses:

• Mycophenolate mofetil > 2 g/day
• Methotrexate > 20 mg/week
• Leflunomide > 20 mg/day within 6 months prior to screening or receipt of leflunomide in combination with any dose of methotrexate
• Azathioprine > 2 mg/kg/day
• Cyclosporine (except eye drops); tacrolimus (except topical), sirolimus, thalidomide, lenalidomide, 6-mercaptopurine, or voclosporin
• Hydroxychloroquine > 400 mg/day
• Chloroquine > 250 mg/day
• Quinacrine > 100 mg/day
• Sulfasalazine > 3 g/day, except that no more than 1 g/day is permitted if used in combination with methotrexate
• Dapsone > 100 mg/day
• Danazol > 800 mg/day
• Any other nonbiologic immunosuppressive/immunomodulatory agent not already specified (eg, mizoribine, retinoids, adrenocorticotropic hormone analogs, dehydroepiandrosterone [DHEA]) within 2 weeks prior to screening.
• Receipt of any biologic B cell-depleting therapy within 12 months or non-depleting B cell-directed therapy within 6 months
• Receipt of abatacept, etanercept, or other biologic immunomodulatory agent or immunoglobulins within 3 months
• Receipt of any other biologic disease modifying antirheumatic drug (bDMARD) not already specified, such as any targeted therapy (other than Janus kinase [JAK] inhibitor), or receipt of cyclophosphamide or chlorambucil within 6 months
• Receipt of JAK inhibitors within 3 months
• Receipt of anticoagulants other than anti-platelet drugs in prior 28 days
• Active malignancy, history of malignancy within prior 10 years (limited exceptions) or known first degree relative with a hereditary cancer syndrome unless the patient is known to be free of the predisposing genetic mutation
• Receipt of live vaccine or live therapeutic infectious agent within the 28 days prior to screening.
• Pregnancy, lactation, or planning to become pregnant or donate/retrieve eggs before the end of study follow-up.
• Hepatitis B or C infection, HIV infection, evidence of active TB or being at high risk for TB
• History of any severe herpes virus infection (including any history of severe Epstein-Barr virus, cytomegalovirus disease, end-organ disease, disseminated herpes simplex, disseminated zoster, or ophthalmic zoster) or > 1 episode of herpes zoster in the 2 years prior to screening and/or any opportunistic infection in the prior 2 years
• Infection requiring parenteral antimicrobial therapy within 60 days of screening or any clinically significant active or suspected infection ( within 28 days prior to screening
• History of anaphylaxis to any human immunoglobulin therapy or monoclonal antibody.
• Blood tests at screening (performed in the central laboratory) that meet study requirements including but not limited to normal coagulation testing and glomerular filtration rate < 50 mL/min/1.73
• High risk for COVID-19 or for severe COVID-19