Phase 1b Study of ABBV-319 Intravenous Infusions to Evaluate Safety, How the Drug Works, and Effectiveness in Adults with Systemic Lupus Erythematosus, Sjogrens Disease, and Rheumatoid Arthritis

What this Trial Is About

Systemic lupus erythematosus SLE, Sjogrens disease SjD, and rheumatoid arthritis RA are chronic autoimmune diseases characterized by B cell hyperactivity or immune system attacks on the bodys own tissues. This research aims to assess the pharmacokinetics, safety, and effectiveness of ABBV-319, an investigational drug that may reduce B cell activity in adults with these conditions. The trial enrolls about 48 adults with SLE, SjD, or RA at multiple sites worldwide. Participants are assigned to one of eight groups based on their condition and receive two intravenous doses of ABBV-319 spaced 21 days apart. Each group receives a different dose tailored to their specific disease SLE, SjD, or RA. The study follows participants for up to 343 days after dosing to monitor effects and safety. During the study, participants attend regular visits at hospitals or clinics for medical assessments, blood tests, and questionnaires to evaluate side effects and treatment impact. Researchers measure adverse events, changes in B cells in blood and tissue, drug concentration in plasma, and the presence of anti-drug antibodies. Monitoring continues for up to approximately 400 days to gather comprehensive safety and efficacy data.

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)