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New drug ABBV-519 enters first human tests for lupus and arthritis

NCT ID NCT07607964

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This early-stage study tests a single dose of ABBV-519 in 30 adults with moderate lupus or rheumatoid arthritis. Researchers will check how the drug moves through the body, how it affects immune cells, and whether it is safe. Participants will be followed for about a year to monitor side effects and immune response.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Quality Medical Research /ID# 279147

    RECRUITING

    Orland Park, Illinois, 60462, United States

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

    RECRUITING

    Clearwater, Florida, 33765, United States

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

    RECRUITING

    Tampa, Florida, 33606, United States

  • Clinical Research of Osceola /ID# 278374

    RECRUITING

    Kissimmee, Florida, 34741, United States

  • Discovery Health Research Center /ID# 279691

    RECRUITING

    Plantation, Florida, 33317, United States

  • Epic Medical Research /ID# 279180

    RECRUITING

    Red Oak, Texas, 75154, United States

  • Finlay Medical Research - Greenacres /ID# 278380

    RECRUITING

    Greenacres City, Florida, 33467, United States

  • Institute of Science Tokyo Hospital /ID# 279648

    RECRUITING

    Bunkyo-ku, Tokyo, 113-8519, Japan

  • Pinnacle Research Group /ID# 278677

    RECRUITING

    Anniston, Alabama, 36207, United States

  • Solace Research /ID# 279155

    RECRUITING

    Tustin, California, 92780, United States

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