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)

Study Identifier
M25-433
CT.gov Identifier
NCT06977724
EudraCT Identifier
Not available
EUCTIS ID
2024-519157-10
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Dry Eye
  • Lupus (Systemic Lupus Erythematosus (SLE))
    • Study Drug
  • ABBV-319
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Life Clinical Trials - Colonial Drive - Margate /ID# 276050
    Margate, Florida, United States, 33063
    Status
    Recruiting
    Location
    Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
    Tampa, Florida, United States, 33606
    Status
    Recruiting
    Location
    Private Practice - Dr. Ramesh C. Gupta I /ID# 275826
    Memphis, Tennessee, United States, 38119
    Status
    Recruiting
    Location
    Integrative Rheumatology of South Texas - Harlingen /ID# 276458
    Harlingen, Texas, United States, 78550
    Status
    Recruiting
    Location
    Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
    Strasbourg, Alsace, France, 67200
    Status
    Recruiting
    Location
    Amsterdam UMC, locatie AMC /ID# 274286
    Amsterdam, North Holland, Netherlands, 1105 AZ
    Status
    Recruiting
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