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)
Public ClinicalTrials.gov record NCT07607964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07607964
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 28, 2026 (Actual)
- Primary completion
- Jan 2029 (Estimated)
- Completion
- Jan 2029 (Estimated)
- Last update posted
- Oct 15, 2026
2026 – 2029
United States locations
- U.S. sites
- 11
- U.S. states
- 6
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group /ID# 278677 | Anniston | Alabama | 36207 | Recruiting |
| Solace Research /ID# 279155 | Tustin | California | 92780 | Recruiting |
| Clinical Research Of West Florida - Phase I Unit /ID# 279292 | Clearwater | Florida | 33765 | Recruiting |
| Finlay Medical Research - Greenacres /ID# 278380 | Greenacres City | Florida | 33467 | Recruiting |
| Clinical Research of Osceola /ID# 278374 | Kissimmee | Florida | 34741 | Recruiting |
| Allied Biomedical Research Institute /ID# 284408 | Miami | Florida | 33155 | Recruiting |
| Discovery Health Research Center /ID# 279691 | Plantation | Florida | 33317 | Recruiting |
| Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130 | Tampa | Florida | 33606 | Recruiting |
| Advanced Quality Medical Research /ID# 279147 | Orland Park | Illinois | 60462 | Recruiting |
| West Tennessee Research Institute - Jackson /ID# 284561 | Jackson | Tennessee | 38305 | Recruiting |
| Epic Medical Research /ID# 279180 | Red Oak | Texas | 75154 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07607964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07607964 live on ClinicalTrials.gov.