Study of VIB7734 for the Treatment of Moderate to Severely Active SLE

Inclusion Criteria

• •Age ≥ 18 years to ≤ 70 years
• •Willing and able to understand and provide written informed consent.
• •Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
• •Disease duration of at least 6 months
• •Active SLE as indicated by presence of all the following:
• •1. SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
• •2. SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
• •3. At least one of the following BILAG 2004 Index levels of disease at Screening:
• •BILAG A disease in ≥ 1 organ system
• •BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening
• •Have at least one of the following at Screening per central lab:
• •ANA ≥ 1:80
• •Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
• •Anti-Smith antibodies elevated to above normal (ie, positive results) Ongoing treatment for SLE
• •1. Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):
• •2. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
• •* Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.
• •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.
• •Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.