ABBV-519 in adults with SLE or RA: safety and how the drug moves through the body after IV and subcutaneous doses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single ascending dose study evaluating ABBV-519 in adults with moderate SLE or RA. The trial aims to characterize pharmacokinetics and pharmacodynamics, as well as safety and tolerability, following intravenous and subcutaneous administration. Approximately 30 participants will be enrolled across 15–20 sites globally, with a 60-day screening period, a 1-day treatment period, and about a 52-week follow-up. Participants will undergo regular clinic visits, blood tests, safety assessments, and monitoring for adverse events. The study design may impose additional burdens beyond standard care due to study procedures and visits.

Why it matters

Who can join: the full rules

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 uncontrolled hypertension

Exclusion for SLE Participants:

* Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).

  \- Unstable or progressive glomerulonephritis (active class III or IV).
* SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.

Exclusion for RA Participants:

\-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.

Where it's running

• Pinnacle Research Group /ID# 278677
  Anniston, Alabama, United States Recruiting
• Solace Research /ID# 279155
  Tustin, California, United States Recruiting
• Clinical Research Of West Florida - Phase I Unit /ID# 279292
  Clearwater, Florida, United States Recruiting
• Finlay Medical Research - Greenacres /ID# 278380
  Greenacres City, Florida, United States Recruiting
• Clinical Research of Osceola /ID# 278374
  Kissimmee, Florida, United States Recruiting
• Allied Biomedical Research Institute /ID# 284408
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.