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[M25-989]A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

[M25-989]A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects with Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

Otani Tetsuya

AbbVie GK

3-1-21, Shibaura, Minato-ku Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact for Patients and HCP

AbbVie GK

3-1-21, Shibaura, Minato-ku Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Pending

Sept. 07, 2026

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

basic science

Key Inclusion Criteria
Individuals between 18 and 75 years of age inclusive at the time of Screening.
Minimum baseline B-cell count of 50 cells/mcL.

Inclusion Criteria for SLE Participants
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.

Inclusion Criteria for RA Participants
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.

[Key Exclusion Criteria]
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.

Both

Systemic Lupus Erythematosus
Rheumatoid Arthritis

Drug: ABBV-519
-Intravenous (IV) Infusion

Drug: ABBV-519
-Subcutaneous (SC) Injection

Change from Baseline in B Cells in Blood
Cmax of ABBV-519
Tmax of ABBV-519
t1/2 of ABBV-519
AUCt of ABBV-519
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519
Number of Participants with Adverse Events (AEs)

Aug. 25, 2026

No

United States