Status:
RECRUITING
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)
Lead Sponsor:
AbbVie
Conditions:
Dry Eye Syndrome
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 characteriz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06977724
Start Date
August 26 2025
End Date
March 1 2029
Last Update
December 30 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Life Clinical Trials /ID# 276050
Margate, Florida, United States, 33063
2
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida, United States, 33606
3
Private Practice - Dr. Ramesh C. Gupta I /ID# 275826
Memphis, Tennessee, United States, 38119
4
Amsterdam UMC, locatie AMC /ID# 274286
Amsterdam, North Holland, Netherlands, 1105 AZ