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NCT06977724PHASE1Recruiting

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)

AbbVie

Start Date

8/26/2025

Completion Date

3/1/2029

Summary

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. 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 and Rheumatoid arthritis (RA) is a long-lasting autoimmune disease that causes the body's immune system to attack itself. RA targets the body's joints, causing inflammation (swelling, pain, and redness). ABBV-319 exhibits potential B cell depletion in SLE, SjD and RA 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, SjD and RA. ABBV-319 is an investigational drug being developed for the treatment of SLE , SjD and RA. Participants are placed in 1 of 8 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE, SjD or RA. Around 48 adult participants with SLE, SjD or RA will be enrolled at approximately up to 17 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

Age Range: 18 years to 75 years

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.

Interventions

DRUG

ABBV-319

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Conditions

Dry Eye SyndromeSystemic Lupus Erythematosus

Locations

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

Avon Park, Florida 33825

United States

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

Clearwater, Florida 33765

United States

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

Margate, Florida 33063

United States

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

Tampa, Florida 33606

United States

Advanced Quality Medical Research /ID# 278462

Orland Park, Illinois 60462

United States

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

Memphis, Tennessee 38119

United States

Integrative Rheumatology of South Texas - Harlingen /ID# 276458

Harlingen, Texas 78550

United States

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

Strasbourg, Alsace 67200

France

CHU de Montpellier - Hopital Lapeyronie /ID# 279892

Montpellier, Herault 34090

France

Amsterdam University Medical Center /ID# 274286

Amsterdam, North Holland 1105 AZ

Netherlands

Universitair Medisch Centrum Utrecht /ID# 273398

Utrecht, 3584 CX

Netherlands