Actively Recruiting
Phase 1 Study Evaluating ABBV-519 Intravenous and Subcutaneous Doses in Adults with Systemic Lupus Erythematosus or Rheumatoid Arthritis
Led by AbbVie · Updated on 2026-07-01
30
Participants Needed
10
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying adults with Systemic Lupus Erythematosus SLE or Rheumatoid Arthritis RA, chronic autoimmune and inflammatory diseases, to assess how the drug ABBV-519 behaves in the body, its effects, and safety. This Phase 1 study focuses on participants with moderate SLE or RA and aims to understand the pharmacokinetics, pharmacodynamics, and safety profile of ABBV-519. Participants will receive a single dose of ABBV-519 either by intravenous infusion or subcutaneous injection. The study includes five groups receiving different doses of the drug. The total study duration is approximately 425 days, which includes a 60-day screening period, a 1-day treatment period, and a 52-week follow-up period to monitor participants after treatment. During the study, participants will attend regular visits at hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will measure changes in B cells, drug concentration in blood over time, detection of anti-drug antibodies, and adverse events. The long follow-up period allows careful monitoring of participants health and the drugs effects.
CONDITIONS
Brief Title
A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Research Team
A
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