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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Pinnacle Research Group /ID# 278677
Anniston, Alabama, United States
RECRUITINGSolace Research /ID# 279155
Tustin, California, United States
RECRUITINGClinical Research Of West Florida - Phase I Unit /ID# 279292
Clearwater, Florida, United States
RECRUITINGFinlay Medical Research - Greenacres /ID# 278380
Greenacres City, Florida, United States
RECRUITINGClinical Research of Osceola /ID# 278374
Kissimmee, Florida, United States
RECRUITINGAllied Biomedical Research Institute /ID# 284408
Miami, Florida, United States
RECRUITINGDiscovery Health Research Center /ID# 279691
Plantation, Florida, United States
RECRUITINGClinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
Tampa, Florida, United States
RECRUITINGAdvanced Quality Medical Research /ID# 279147
Orland Park, Illinois, United States
RECRUITINGWest Tennessee Research Institute - Jackson /ID# 284561
Jackson, Tennessee, United States
RECRUITING...and 3 more locations
Change from Baseline in B Cells in Blood
Change from baseline in B cells in blood.
Time frame: Up to 365 Days
Maximum Plasma Concentration (Cmax) of ABBV-519.
Cmax of ABBV-519
Time frame: Up to 85 Days
Time to Cmax (Tmax) of ABBV-519
Tmax of ABBV-519
Time frame: Up to 85 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
t1/2 of ABBV-519
Time frame: Up to 85 Days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519
AUCt of ABBV-519
Time frame: Up to 85 Days
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519
Percentage of participants with detection of ADAs for ABBV-519
Time frame: Up to 169 Days
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 425 Days
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