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)
3 other identifiers
interventional
36
2 countries
5
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2025
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 18, 2025
CompletedStudy Start
First participant enrolled
August 26, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
March 5, 2026
March 1, 2026
3.5 years
May 12, 2025
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 400 days
Change from Baseline in B Cells in Blood and Tissue
Change from baseline in B cells in blood and tissue.
Up to approximately 400 days
Maximum Plasma Concentration (Cmax) of ABBV-319
Cmax of ABBV-319.
Up to approximately 400 days
Time to Cmax (Tmax) of ABBV-319
Tmax of ABBV-319.
Up to approximately 400 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
t1/2 of ABBV-319.
Up to approximately 400 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319
AUCt of ABBV-319.
Up to approximately 400 days
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319
Percentage of participants with detection of ADAs for ABBV-319.
Up to approximately 400 days
Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319
Percentage of participants with detection of nAbs for ABBV-319.
Up to approximately 400 days
Study Arms (6)
ABBV-319 Group 1: SLE Participants
EXPERIMENTALSystemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.
ABBV-319 Group 2: SLE Participants
EXPERIMENTALSLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.
ABBV-319 Group 3: SLE Participants
EXPERIMENTALSLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.
ABBV-319 Group 4: SLE Participants
EXPERIMENTALSLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.
ABBV-319 Group 5: SjD Participants
EXPERIMENTALSjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
ABBV-319 Group 6: SjD Participants
EXPERIMENTALSjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
Interventions
Intravenous (IV) Infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (5)
Life Clinical Trials /ID# 276050
Margate, Florida, 33063, United States
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa, Florida, 33606, United States
Private Practice - Dr. Ramesh C. Gupta I /ID# 275826
Memphis, Tennessee, 38119, United States
Amsterdam UMC, locatie AMC /ID# 274286
Amsterdam, North Holland, 1105 AZ, Netherlands
Universitair Medisch Centrum Utrecht /ID# 273398
Utrecht, 3584 CX, Netherlands
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 18, 2025
Study Start
August 26, 2025
Primary Completion (Estimated)
March 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share