Clareo Health | 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)
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)
Individuals between 18 and 75 years of age inclusive at the time of Screening.
Minimum baseline B-cell count of 50 cells/mcL.
Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria.
Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).
Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.
Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.
Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.
Presence of at least 6 swollen and 6 tender joints
High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L.
Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.
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Participants with a history of infection.
Participants with uncontrolled hypertension
Exclusion for SLE Participants:
Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).
\- Unstable or progressive glomerulonephritis (active class III or IV).
SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.
Exclusion for RA Participants:
\-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.
