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:

• SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
• 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).
• 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

• 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):
• 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.

Exclusion criteria

• Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)
• History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy
• Active LN or active severe or unstable neuropsychiatric SLE
• Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome
• Participation in another clinical study with an investigational drug within 4 weeks before Day 1
• Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
• Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
• Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening
• Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection
• Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection
• History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or congestive heart failure within 6 months prior to Randomization.
• History of cancer within the past 5 years except, in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.
• Receipt of a live-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable
• The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods