Actively 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)
Led by AbbVie · Updated on 2026-05-12
36
Participants Needed
6
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of systemic lupus erythematosus (SLE) for at least 6 months before screening, meeting 2019 EULAR/ACR SLE classification criteria
- Positive antinuclear antibody (ANA) titer of 1:80 or higher at screening
- Presence of anti-dsDNA, anti-Smith, anti-RNP, or anti-SSA antibodies above normal limits for SLE participants
- Primary diagnosis of Sjogren's disease (SjD) for at least 6 months before screening, meeting 2016 ACR/EULAR criteria
- EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) score of 5 or higher at screening for SjD participants
- EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score of 5 or higher at screening for SjD participants
You will not qualify if you...
- History of infection as defined in the study protocol
- Presence of certain medical diseases or disorders listed in the protocol
- Clinically significant drug or alcohol abuse within 6 months before screening
- Planned elective surgery that would affect study procedures or assessments through day 365
- Clinically significant ECG abnormalities at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Life Clinical Trials - Colonial Drive - Margate /ID# 276050
Margate, Florida, United States, 33063
Actively Recruiting
2
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida, United States, 33606
Actively Recruiting
3
Private Practice - Dr. Ramesh C. Gupta I /ID# 275826
Memphis, Tennessee, United States, 38119
Actively Recruiting
4
Integrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen, Texas, United States, 78550
Actively Recruiting
5
Amsterdam UMC, locatie AMC /ID# 274286
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
6
Universitair Medisch Centrum Utrecht /ID# 273398
Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here