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NCT Number: 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) and Sjogren's Disease (SjD)

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.

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Key information

Conditions

Dry Eye Syndrome Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Lacrimal Apparatus Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Systemic Lupus Erythematosus

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692, Strasbourg, Alsace, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 - Presence of 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.

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.

Treatment and study plan

ABBV-319

Drug

Intravenous (IV) Infusion

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

  2. Change from Baseline in B Cells in Blood and Tissue

    Time frame: Up to approximately 400 days

    Change from baseline in B cells in blood and tissue.

  3. Maximum Plasma Concentration (Cmax) of ABBV-319

    Time frame: Up to approximately 400 days

    Cmax of ABBV-319.

  4. Time to Cmax (Tmax) of ABBV-319

    Time frame: Up to approximately 400 days

    Tmax of ABBV-319.

  5. Terminal Phase Elimination Half-Life (t1/2) of ABBV-319

    Time frame: Up to approximately 400 days

    t1/2 of ABBV-319.

  6. Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319

    Time frame: Up to approximately 400 days

    AUCt of ABBV-319.

  7. Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319

    Time frame: Up to approximately 400 days

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

  8. Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319

    Time frame: Up to approximately 400 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase1b, Multiple Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Safety, and Efficacy of ABBV-319 in Subjects With Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD)

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 18, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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