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), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
← catalyst calendarNCT06977724 · readout ≤ 954 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
36estimated
Sites
11
Countries
France, Netherlands, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-26 | actual | When the study began enrolling |
| Primary completion | Mar 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Dry Eye Syndrome
- Systemic Lupus Erythematosus
Intervention
- Drug: ABBV-319
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AEs)
measured Up to approximately 400 days
Change from Baseline in B Cells in Blood and Tissue
measured Up to approximately 400 days
Maximum Plasma Concentration (Cmax) of ABBV-319
measured Up to approximately 400 days
Time to Cmax (Tmax) of ABBV-319
measured Up to approximately 400 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
measured Up to approximately 400 days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319
measured Up to approximately 400 days
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319
measured Up to approximately 400 days
Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319
measured Up to approximately 400 days
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