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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)

NCT ID: NCT07607964
Registry status: Recruiting
Study type: Interventional
Phase: Phase 1
Sponsor: AbbVie
Conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus

Overview

ClinicalTrials.gov lists this study as Recruiting.

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)

Enrollment: 30 participants (Estimated).

What is being studied

Drug: ABBV-519

Who may be eligible

Ages: 18 Years to 75 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

13 study locations are listed.

Recruiting site status is explicitly provided for 13 locations; 13 are listed as Recruiting.

Countries: Japan, United States

Aichi-ken, Japan: 1
Tokyo, Japan: 1
Alabama, United States: 1
California, United States: 1
Florida, United States: 6
Illinois, United States: 1
Tennessee, United States: 1
Texas, United States: 1

Sample of listed locations

Japan Community Healthcare Organization Chukyo Hospital /ID# 279611 — Nagoya, Aichi-ken, 457-8510, Japan — Recruiting
Institute of Science Tokyo Hospital /ID# 279648 — Bunkyo-ku, Tokyo, 113-8519, Japan — Recruiting
Pinnacle Research Group /ID# 278677 — Anniston, Alabama, 36207, United States — Recruiting
Solace Research /ID# 279155 — Tustin, California, 92780, United States — Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 279292 — Clearwater, Florida, 33765, United States — Recruiting
Finlay Medical Research - Greenacres /ID# 278380 — Greenacres City, Florida, 33467, United States — Recruiting
Clinical Research of Osceola /ID# 278374 — Kissimmee, Florida, 34741, United States — Recruiting
Allied Biomedical Research Institute /ID# 284408 — Miami, Florida, 33155, United States — Recruiting
Discovery Health Research Center /ID# 279691 — Plantation, Florida, 33317, United States — Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130 — Tampa, Florida, 33606, United States — Recruiting
Advanced Quality Medical Research /ID# 279147 — Orland Park, Illinois, 60462, United States — Recruiting
West Tennessee Research Institute - Jackson /ID# 284561 — Jackson, Tennessee, 38305, United States — Recruiting
Epic Medical Research /ID# 279180 — Red Oak, Texas, 75154, United States — Recruiting

Study details

Start date: May 28, 2026
Primary completion date: January 1, 2029
Completion date: January 1, 2029
First posted: May 27, 2026

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07607964
Registry last updated: September 25, 2026
QualifiedStudies registry data refreshed: October 2, 2026
QualifiedStudies record fetched: October 2, 2026

View NCT07607964 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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