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) and Sjogren's Disease (SjD)

Last updated: May 15, 2026
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

1

Condition

Sjogren's Syndrome

Lupus

Dermatomyositis (Connective Tissue Disease)

Treatment

ABBV-319

Clinical Study ID

NCT06977724
M25-433
2024-519157-10-00
2024-519157-10
  • Ages 18-75
  • All Genders

Study Summary

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and Sjorgren's disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement. ABBV-319 exhibits potential B cell depletion in SLE and SjD which are characterized by B cell hyperactivity. The purpose of this study is to assess the pharmacokinetics, safety, and efficacy of ABBV-319 in adult participants with SLE or SjD.

ABBV-319 is an investigational drug being developed for the treatment of SLE and SjD. Participants are placed in 1 of 6 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE or SjD. Around 36 adult participants with SLE or SjD will be enrolled at approximately 10 sites worldwide.

Participants will receive 2 doses of IV ABBV-319 21 days apart and will be followed for up to 343 days.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6months prior to Screening as defined by the 2019 European Alliance of Associationsfor Rheumatology (EULAR)/American College Of Rheumatology (ACR) classificationcriteria for SLE and a positive antinuclear antibody (ANA) >= 1:80 drawn atScreening.

  • SLE Population - Presence of anti-double stranded DNA (dsDNA), anti-Smith (Sm),anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above theupper limit of normal (ULN).

  • Sjogren's Disease (SjD) Population - Primary diagnosis of SjD at least 6 monthsprior to Screening as defined by the ACR/EULAR 2016 Criteria.

  • SjD Population - EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) >= 5 atScreening.

  • SjD Population - EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) >= 5 atScreening.

Exclusion

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 alcoholabuse within the 6 months prior to Screening.

  • Any planned elective surgery that would impact study procedures or assessmentsthrough the completion of the Day 365 assessments.

  • Any clinically significant ECG abnormalities at Screening.

Study Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: ABBV-319
Phase: 1
Study Start date:
August 26, 2025
Estimated Completion Date:
March 31, 2029

Connect with a study center

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

    Strasbourg, Alsace 67200
    France

    Active - Recruiting

  • Amsterdam UMC, locatie AMC /ID# 274286

    Amsterdam, North Holland 1105 AZ
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht /ID# 273398

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

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

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Life Clinical Trials /ID# 276050

    Margate, Florida 33063
    United States

    Active - Recruiting

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

    Tampa, Florida 33606
    United States

    Active - Recruiting

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

    Memphis, Tennessee 38119
    United States

    Active - Recruiting

  • Dr. Ramesh Gupta /ID# 275826

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Active - Recruiting

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

    Harlingen, Texas 78550
    United States

    Active - Recruiting

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