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)
Start Date
5/28/2026
Completion Date
1/1/2029
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
ABBV-519
ABBV-519
Conditions
Locations
Pinnacle Research Group /ID# 278677
Anniston, Alabama 36207
United States
UCLA Health West Medical Campus /ID# 282811
Los Angeles, California 90095
United States
Solace Research /ID# 279155
Tustin, California 92780
United States
Clinical Research Of West Florida - Phase I Unit /ID# 279292
Clearwater, Florida 33765
United States
Finlay Medical Research - Greenacres /ID# 278380
Greenacres City, Florida 33467
United States
Clinical Research of Osceola /ID# 278374
Kissimmee, Florida 34741
United States
Discovery Health Research Center /ID# 279691
Plantation, Florida 33317
United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
Tampa, Florida 33606
United States
Advanced Quality Medical Research /ID# 279147
Orland Park, Illinois 60462
United States
Epic Medical Research /ID# 279180
Red Oak, Texas 75154
United States