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Study of ABBV-319 for Systemic Lupus Erythematosus and Sjogren's Disease

This study is testing an investigational drug called ABBV-319, given through an IV, for adults with Systemic Lupus Erythematosus (SLE) or Sjogren's Disease (SjD). Both conditions involve an overactive immune system, specifically B cells. ABBV-319 aims to reduce these B cells. The study will look at how safe ABBV-319 is, how it moves through your body, and if it helps improve your condition. To join, you must be between 18 and 75 years old and have a diagnosis of SLE (with a positive ANA test) or SjD. The study plans to enroll 36 participants, but its current recruitment status is unclear.

Study design
This interventional study plans to enroll 36 adult participants, who will be placed into one of six treatment groups to receive ABBV-319.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 400 days to assess safety and changes in B cells.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06977724

A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)

Recruiting
PHASE1Ages 18–75InterventionalTreatment
AbbVie
~36 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:ABBV-319

At a glance

Recruiting sites
9 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Adverse Events (AEs)
Measured over Up to approximately 400 days
+7 more outcomes measured

Conditions

Dry Eye Syndrome
Systemic Lupus Erythematosus

Explore related trials

Sjogren SyndromeSystemic Lupus ErythematosusAnti-ds DNA AntibodyAntinuclear AntibodyAnti-Ribonucleoprotein Antibodyanti-Smanti-SSA

Where it's being run

11 sites across 8 states
Florida4
Illinois1
Tennessee1
Texas1
Alsace1
Herault1
North Holland1
Netherlands1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Adverse Events (AEs)Up to approximately 400 days

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  • Change from Baseline in B Cells in Blood and TissueUp to approximately 400 days

    Change from baseline in B cells in blood and tissue.

  • Maximum Plasma Concentration (Cmax) of ABBV-319Up to approximately 400 days

    Cmax of ABBV-319.

  • Time to Cmax (Tmax) of ABBV-319Up to approximately 400 days

    Tmax of ABBV-319.

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-319Up to approximately 400 days

    t1/2 of ABBV-319.

  • Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319Up to approximately 400 days

    AUCt of ABBV-319.

  • Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319Up to approximately 400 days

    Percentage of participants with detection of ADAs for ABBV-319.

  • Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319Up to approximately 400 days

    Percentage of participants with detection of nAbs for ABBV-319.