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)

Launched by ABBVIE · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ABBV-319 for adults diagnosed with Systemic Lupus Erythematosus (SLE) and Sjogren's Disease (SjD). SLE is an autoimmune disease that affects the entire body, while SjD mainly causes dryness in the eyes and mouth. The goal of the study is to understand how the drug works in the body, how safe it is, and whether it is effective in reducing symptoms for people with these conditions. About 36 participants will receive two doses of ABBV-319 through an intravenous infusion, spaced 21 days apart, and will be monitored for almost a year to check for any side effects and improvements in their health.

To be eligible for this trial, participants must have a confirmed diagnosis of SLE or SjD for at least six months and meet specific medical criteria set by health guidelines. Those who join the trial will need to attend regular visits at a hospital or clinic, where they will undergo various assessments, including blood tests and questionnaires about their symptoms. While participants may experience more visits and procedures than usual compared to their standard care, the study aims to provide valuable information about a potential new treatment for these chronic conditions.

Gender

ALL

Eligibility 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.