Clinical Trial

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)

Recruiting Phase 1
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Summary
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA. This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Protocol Amendment History 2 changes
notable Trial sites expanded: 6 -> 9 locations 2026-06-19
critical Recruitment opened 2026-05-30
Trial Details
NCT Number NCT07607964
Lead Sponsor AbbVie
Conditions Systemic Lupus Erythematosus, Rheumatoid Arthritis
Enrollment 30 participants
Start Date 2026-05-28
Primary Completion 2029-01 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-01