RecruitingPhase 1NCT07607964

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)

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)


Sponsor

AbbVie

Enrollment

30 participants

Start Date

May 28, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ABBV-519 and a drug called ABBV-519 for people with rheumatoid arthritis and systemic lupus erythematosus. The study is currently recruiting participants at 5 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABBV-519

Intravenous (IV) Infusion

DRUGABBV-519

Subcutaneous (SC) Injection


Locations(5)

UCLA Health West Medical Campus /ID# 282811

Los Angeles, California, United States

Solace Research /ID# 279155

Tustin, California, United States

Finlay Medical Research - Greenacres /ID# 278380

Greenacres City, Florida, United States

Discovery Health Research Center /ID# 279691

Plantation, Florida, United States

Epic Medical Research /ID# 279180

Red Oak, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07607964


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