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New drug aims to tame immune system in lupus and Sjogren's

NCT ID NCT06977724

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 11, 2026 · Updated 2 times

Summary

This early-stage trial tests an investigational drug called ABBV-319 in 36 adults with lupus or Sjogren's disease. The drug is designed to deplete overactive B cells, which are part of the immune system that cause inflammation and symptoms. Participants receive two doses by IV, 21 days apart, and are monitored for safety, side effects, and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-319
What this could lead to
If it works, this could point toward a new treatment option for lupus and Sjogren's disease by reducing harmful immune cells.
What could go wrong
This is a very early Phase 1 trial with only 36 people, so it's mainly checking safety and dosing. It may not improve symptoms, and side effects are unknown.

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 36 people

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

Started

Aug 2025

Expected to finish

Mar 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: * Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6 months prior to Screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College Of Rheumatology (ACR) classification criteria for SLE and a positive antinuclear antibody (ANA) \>= 1:80 drawn at Screening. * SLE Population - Anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above the upper limit of normal (ULN). * Sjogren's Disease (SjD) Population - Primary diagnosis of SjD at least 6 months prior to Screening as defined by the ACR/EULAR 2016 Criteria. * SjD Population - EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) \>= 5 at Screening. * SjD Population - EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) \>= 5 at Screening. * Rheumatoid Arthritis (RA) Population - Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA. * RA Population - Rheumatoid Factor (RF) or ACPA above the ULN at Screening. * RA Population - Confirmation of at least moderate disease activity at Screening, defined by both of the following disease activity criteria: * Presence of at least 6 swollen and 6 tender joints at Screening using the 68 (tender)/66 (swollen) joint count. * hs-CRP ≥3 mg/L. Exclusion Criteria: * History of infection as defined in the protocol. * Any of the medical diseases or disorders listed in the protocol. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the 6 months prior to Screening. * Any planned elective surgery that would impact study procedures or assessments through the completion of the Day 365 assessments. * Any clinically significant ECG abnormalities at Screening. * RA-Specific Exclusion Criteria - History of RA overlap syndromes, including but not limited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome rheumatoid arthritis Sjogren syndrome systemic lupus erythematosus

As listed by the trial registrant

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

Dry eye syndrome 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

    11 sites in 3 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# 278462

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • Amsterdam University Medical Center /ID# 274286

    RECRUITING

    Amsterdam, North Holland, 1105 AZ, Netherlands

  • CHU de Montpellier - Hopital Lapeyronie /ID# 279892

    RECRUITING

    Montpellier, Herault, 34090, France

  • Clinical Research Of West Florida - Phase I Unit /ID# 275834

    NOT_YET_RECRUITING

    Clearwater, Florida, 33765, United States

  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836

    RECRUITING

    Tampa, Florida, 33606, United States

  • Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239

    NOT_YET_RECRUITING

    Avon Park, Florida, 33825, United States

  • Integrative Rheumatology of South Texas - Harlingen /ID# 276458

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692

    RECRUITING

    Strasbourg, Alsace, 67200, France

  • Life Clinical Trials - Colonial Drive - Margate /ID# 276050

    RECRUITING

    Margate, Florida, 33063, United States

  • Private Practice - Dr. Ramesh C. Gupta /ID# 275826

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Universitair Medisch Centrum Utrecht /ID# 273398

    RECRUITING

    Utrecht, 3584 CX, Netherlands

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