A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intrav… (NCT07607964) | Clinical Trial Compass
RecruitingPhase 1
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)
United States30 participantsStarted 2026-05-28
Plain-language summary
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.
This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Key Inclusion Criteria:
* Individuals between 18 and 75 years of age inclusive at the time of Screening.
* Minimum baseline B-cell count of 50 cells/mcL.
Inclusion Criteria for SLE Participants:
* Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria.
* Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).
* Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.
* Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.
Inclusion Criteria for RA Participants:
* Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA.
* Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.
* Presence of at least 6 swollen and 6 tender joints
* High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L.
* Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.
Exclusion Criteria:
Key Exclusion Criteria:
* Participants with a history of infection.
* Participants with un…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on safety and how ABBV-519 moves through the body rather than proving it works, what does that mean for my personal risk compared to my potential benefit if I were to consider joining?
2The trial is measuring changes in B cells in the blood — can you explain what role B cells play in my specific condition, either lupus or rheumatoid arthritis, and why targeting them matters for my disease?
3The study is comparing intravenous infusions and subcutaneous injections of ABBV-519, so could you walk me through what the visit schedule and time commitment might realistically look like for each of those delivery methods?
4One thing the trial is tracking is whether my body develops antibodies against the drug itself — what would that mean for my health or my future treatment options if that happened?
5Given that this is an early-phase study, would it make sense to try an already-approved treatment for my condition first, or are there reasons my situation might make this trial worth a closer look?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in B Cells in Blood
Timeframe: Up to 365 Days
2
Maximum Plasma Concentration (Cmax) of ABBV-519.
Timeframe: Up to 85 Days
3
Time to Cmax (Tmax) of ABBV-519
Timeframe: Up to 85 Days
4
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
Timeframe: Up to 85 Days
5
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519
Timeframe: Up to 85 Days
6
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519