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NCT07607964RecruitingPhase 1

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)

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
First submitted
20 May 2026
Start date
28 May 2026
Primary completion date
Jan 2029
Lead sponsor
AbbVie
NCT number
NCT07607964

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 30
  • From 28 May 2026 to the primary completion date, Jan 2029
  • 15 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institute of Science Tokyo Hospital /ID# 279648
Coordinator of this site? Confirm its status
Bunkyo-kuJapanRecruiting
Japan Community Healthcare Organization Chukyo Hospital /ID# 279611
Coordinator of this site? Confirm its status
NagoyaJapanRecruiting
National Center for Global Health and Medicine /ID# 281191
Coordinator of this site? Confirm its status
Shinjuku-kuJapanRecruiting
Pinnacle Research Group /ID# 278677
Coordinator of this site? Confirm its status
AnnistonUnited StatesRecruiting
Clinical Research Of West Florida - Phase I Unit /ID# 279292
Coordinator of this site? Confirm its status
ClearwaterUnited StatesRecruiting
Finlay Medical Research - Greenacres /ID# 278380
Coordinator of this site? Confirm its status
Greenacres CityUnited StatesRecruiting
Accurate Clinical Research - Houston /ID# 278382
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
West Tennessee Research Institute - Jackson /ID# 284561
Coordinator of this site? Confirm its status
JacksonUnited StatesRecruiting
Clinical Research of Osceola /ID# 278374
Coordinator of this site? Confirm its status
KissimmeeUnited StatesRecruiting
Allied Biomedical Research Institute /ID# 284408
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
Advanced Quality Medical Research /ID# 279147
Coordinator of this site? Confirm its status
Orland ParkUnited StatesRecruiting
Discovery Health Research Center /ID# 279691
Coordinator of this site? Confirm its status
PlantationUnited StatesRecruiting
Epic Medical Research /ID# 279180
Coordinator of this site? Confirm its status
Red OakUnited StatesRecruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
Solace Research /ID# 279155
Coordinator of this site? Confirm its status
TustinUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.