Recruiting
Phase 1

ABBV-519

Sponsor:

AbbVie

Code:

NCT07607964

Conditions

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ABBV-519

ABBV-519

Study Details

Brief 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.

Conditions

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Study ID

NCT07607964

Start date

May 28, 2026

Status verified date

Sep, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Group 1: Dose A

Participants will receive a single intravenous (IV) dose of ABBV-519

experimental: Group 2: Dose B

Participants will receive a single intravenous (IV) dose of ABBV-519

experimental: Group 3: Dose C

Participants will receive a single intravenous (IV) dose of ABBV-519

experimental: Group 4: Dose D

Participants will receive a single subcutaneous (SC) dose of ABBV-519

experimental: Group 5: Dose E

Participants will receive a single subcutaneous (SC) dose of ABBV-519

Interventions

ABBV-519

Intravenous (IV) Infusion

ABBV-519

Subcutaneous (SC) Injection

Primary outcome measure

  • Change from Baseline in B Cells in Blood [ Time Frame: Up to 365 Days ]
  • Maximum Plasma Concentration (Cmax) of ABBV-519. [ Time Frame: Up to 85 Days ]
  • Time to Cmax (Tmax) of ABBV-519 [ Time Frame: Up to 85 Days ]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-519 [ Time Frame: Up to 85 Days ]
  • Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519 [ Time Frame: Up to 85 Days ]
  • Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519 [ Time Frame: Up to 169 Days ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 425 Days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Pinnacle Research Group /ID# 278677

Recruiting

Anniston, Alabama, United States, 36207

Solace Research /ID# 279155

Recruiting

Tustin, California, United States, 92780

Clinical Research Of West Florida - Phase I Unit /ID# 279292

Recruiting

Clearwater, Florida, United States, 33765

Finlay Medical Research - Greenacres /ID# 278380

Recruiting

Greenacres City, Florida, United States, 33467

Clinical Research of Osceola /ID# 278374

Recruiting

Kissimmee, Florida, United States, 34741

Discovery Health Research Center /ID# 279691

Recruiting

Plantation, Florida, United States, 33317

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130

Recruiting

Tampa, Florida, United States, 33606

Advanced Quality Medical Research /ID# 279147

Recruiting

Orland Park, Illinois, United States, 60462

Epic Medical Research /ID# 279180

Recruiting

Red Oak, Texas, United States, 75154

More Information

Sponsor

AbbVie

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-08.