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 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)

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 Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: ABBV-519; Drug: ABBV-519

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Withdrawn
      • UCLA Health West Medical Campus /ID# 282811
    • Tustin, California, United States, 92780
      • Recruiting
      • Solace Research /ID# 279155
  • Florida
    • Plantation, Florida, United States, 33317
      • Recruiting
      • Discovery Health Research Center /ID# 279691
  • Texas
    • Red Oak, Texas, United States, 75154
      • Recruiting
      • Epic Medical Research /ID# 279180

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Dose A; Participants will receive a single intravenous (IV) dose of ABBV-519	Drug: ABBV-519; Intravenous (IV) Infusion; Drug: ABBV-519; Subcutaneous (SC) Injection
Experimental: Group 2: Dose B; Participants will receive a single intravenous (IV) dose of ABBV-519	Drug: ABBV-519; Intravenous (IV) Infusion; Drug: ABBV-519; Subcutaneous (SC) Injection
Experimental: Group 3: Dose C; Participants will receive a single intravenous (IV) dose of ABBV-519	Drug: ABBV-519; Intravenous (IV) Infusion; Drug: ABBV-519; Subcutaneous (SC) Injection
Experimental: Group 4: Dose D; Participants will receive a single subcutaneous (SC) dose of ABBV-519	Drug: ABBV-519; Intravenous (IV) Infusion; Drug: ABBV-519; Subcutaneous (SC) Injection
Experimental: Group 5: Dose E; Participants will receive a single subcutaneous (SC) dose of ABBV-519	Drug: ABBV-519; Intravenous (IV) Infusion; Drug: ABBV-519; Subcutaneous (SC) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in B Cells in Blood	Change from baseline in B cells in blood.	Up to 365 Days
Maximum Plasma Concentration (Cmax) of ABBV-519.	Cmax of ABBV-519	Up to 85 Days
Time to Cmax (Tmax) of ABBV-519	Tmax of ABBV-519	Up to 85 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519	t1/2 of ABBV-519	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	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	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.	Up to 425 Days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Arthritis, Rheumatoid
• Other Study ID Numbers: M25-989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No