A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
← catalyst calendarNCT07607964 · readout ≤ 896 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Basic science
Enrollment
30estimated
Sites
10
Country
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 | 2026-05-28 | actual | When the study began enrolling |
| Primary completion | Jan 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-27 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Systemic Lupus Erythematosus
- Rheumatoid Arthritis
Interventions
- Drug: ABBV-519
- Drug: ABBV-519
Primary outcomes
what the primary-completion date above is the date OFChange from Baseline in B Cells in Blood
measured Up to 365 Days
Maximum Plasma Concentration (Cmax) of ABBV-519.
measured Up to 85 Days
Time to Cmax (Tmax) of ABBV-519
measured Up to 85 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
measured Up to 85 Days
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519
measured Up to 85 Days
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519
measured Up to 169 Days
Number of Participants with Adverse Events (AEs)
measured Up to 425 Days
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