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ABBV-519 for Systemic Lupus Erythematosus or Rheumatoid Arthritis

This study is testing a drug called ABBV-519 in adults with Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease, or Rheumatoid Arthritis (RA), which causes joint pain and swelling. Researchers want to understand how ABBV-519 moves through the body (pharmacokinetics), its effects on the body (pharmacodynamics), and its safety when given as an intravenous (IV) infusion or a subcutaneous (SC) injection. The study will look at changes in B cells in the blood and how much ABBV-519 is in the blood over time. You may be able to join if you are between 18 and 75 years old and have a certain level of B cells in your blood. The current status of this study is unclear.

Study design
This is a single ascending dose study involving about 30 adult participants with moderate SLE or RA. It will take place at approximately 15 to 20 sites globally.
What's involved
Your participation would involve a 60-day screening period, a 1-day treatment period, and a 52-week follow-up period, for a total of about 425 days. There may be more procedures than your usual care.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 365 days to measure changes in B cells and up to 85 days to measure drug levels in the blood.

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NCT07607964

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
PHASE1Ages 18–75InterventionalBasic science
AbbVie
~30 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:ABBV-519

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in B Cells in Blood
Measured over Up to 365 Days
+6 more outcomes measured

Conditions

Systemic Lupus Erythematosus
Rheumatoid Arthritis

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Where it's being run

10 sites across 5 states
Florida5
California2
Alabama1
Illinois1
Texas1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

Participants with a history of infection.
Participants with uncontrolled hypertension
Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).
SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.

What this trial measures

  • Change from Baseline in B Cells in BloodUp to 365 Days

    Change from baseline in B cells in blood.

  • Maximum Plasma Concentration (Cmax) of ABBV-519.Up to 85 Days

    Cmax of ABBV-519

  • Time to Cmax (Tmax) of ABBV-519Up to 85 Days

    Tmax of ABBV-519

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-519Up to 85 Days

    t1/2 of ABBV-519

  • Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519Up to 85 Days

    AUCt of ABBV-519

  • Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519Up to 169 Days

    Percentage of participants with detection of ADAs for ABBV-519

  • Number of Participants with Adverse Events (AEs)Up to 425 Days

    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.