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NCT Number: 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)

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.

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Key information

Conditions

Systemic Lupus Erythematosus Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pinnacle Research Group /ID# 278677, Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

ABBV-519

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. Change from Baseline in B Cells in Blood

    Time frame: Up to 365 Days

    Change from baseline in B cells in blood.

  2. Maximum Plasma Concentration (Cmax) of ABBV-519.

    Time frame: Up to 85 Days

    Cmax of ABBV-519

  3. Time to Cmax (Tmax) of ABBV-519

    Time frame: Up to 85 Days

    Tmax of ABBV-519

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-519

    Time frame: Up to 85 Days

    t1/2 of ABBV-519

  5. Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519

    Time frame: Up to 85 Days

    AUCt of ABBV-519

  6. Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519

    Time frame: Up to 169 Days

    Percentage of participants with detection of ADAs for ABBV-519

  7. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 27, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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