RecruitingPhase 1NCT06977724

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)

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)


Sponsor

AbbVie

Enrollment

36 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ABBV-319 for people with systemic lupus erythematosus and dry eye syndrome. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-319

Intravenous (IV) Infusion


Locations(7)

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

Margate, Florida, United States

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

Tampa, Florida, United States

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

Memphis, Tennessee, United States

Integrative Rheumatology of South Texas - Harlingen /ID# 276458

Harlingen, Texas, United States

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

Strasbourg, Alsace, France

Amsterdam UMC, locatie AMC /ID# 274286

Amsterdam, North Holland, Netherlands

Universitair Medisch Centrum Utrecht /ID# 273398

Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT06977724


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