First study of ABBV-519 in adults with lupus or rheumatoid arthritis
Tests ABBV-519 for safety in adults with lupus or rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Anniston, Clearwater, Greenacres City, Houston, Jackson, Kissimmee, Miami, Orland Park, Plantation, Red Oak, Tampa, and Tustin, United StatesSee the 12 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07607964, who can take part
Where in United States
- Pinnacle Research Group /ID# 278677Anniston, United StatesTaking people
- Clinical Research Of West Florida - Phase I Unit /ID# 279292Clearwater, United StatesTaking people
- Finlay Medical Research - Greenacres /ID# 278380Greenacres City, United StatesTaking people
- Accurate Clinical Research - Houston /ID# 278382Houston, United StatesTaking people
- West Tennessee Research Institute - Jackson /ID# 284561Jackson, United StatesTaking people
- Clinical Research of Osceola /ID# 278374Kissimmee, United StatesTaking people
- Allied Biomedical Research Institute /ID# 284408Miami, United StatesTaking people
- Advanced Quality Medical Research /ID# 279147Orland Park, United StatesTaking people
- Discovery Health Research Center /ID# 279691Plantation, United StatesTaking people
- Epic Medical Research /ID# 279180Red Oak, United StatesTaking people
- Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130Tampa, United StatesTaking people
- Solace Research /ID# 279155Tustin, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT07607964
- Record updated
- 20 October 2026
- Original description
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.Read full original descriptionShow less
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.
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: 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); Participants with a history of infection; Participants with uncontrolled hypertension; Exclusion for SLE Participants:; 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.