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NCT07607964From ClinicalTrials.govRecruiting

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
  • Rheumatoid Arthritis

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
AbbVie
Enrolment target
30
Started
28 May 2026
Main results due
January 2029
Study sites
13
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 75 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(13)

  • Pinnacle Research Group /ID# 278677

    Anniston, Alabama, United States

    Recruiting

  • Solace Research /ID# 279155

    Tustin, California, United States

    Recruiting

  • Clinical Research Of West Florida - Phase I Unit /ID# 279292

    Clearwater, Florida, United States

    Recruiting

  • Finlay Medical Research - Greenacres /ID# 278380

    Greenacres City, Florida, United States

    Recruiting

  • Clinical Research of Osceola /ID# 278374

    Kissimmee, Florida, United States

    Recruiting

  • Allied Biomedical Research Institute /ID# 284408

    Miami, Florida, United States

    Recruiting

  • Discovery Health Research Center /ID# 279691

    Plantation, Florida, United States

    Recruiting

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130

    Tampa, Florida, United States

    Recruiting

  • Advanced Quality Medical Research /ID# 279147

    Orland Park, Illinois, United States

    Recruiting

  • West Tennessee Research Institute - Jackson /ID# 284561

    Jackson, Tennessee, United States

    Recruiting

  • Epic Medical Research /ID# 279180

    Red Oak, Texas, United States

    Recruiting

  • Japan Community Healthcare Organization Chukyo Hospital /ID# 279611

    Nagoya, Aichi-ken, Japan

    Recruiting

  • Institute of Science Tokyo Hospital /ID# 279648

    Bunkyo-ku, Tokyo, Japan

    Recruiting

Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07607964. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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