NCT07607964

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
31mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jan 2029

First Submitted

Initial submission to the registry

May 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 28, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

2.6 years

First QC Date

May 20, 2026

Last Update Submit

June 8, 2026

Conditions

Systemic Lupus ErythematosusRheumatoid Arthritis

Keywords

Systemic Lupus ErythematosusRheumatoid Arthritis

Outcome Measures

Primary Outcomes (7)

  • Change from Baseline in B Cells in Blood

    Change from baseline in B cells in blood.

    Up to 365 Days

  • Maximum Plasma Concentration (Cmax) of ABBV-519.

    Cmax of ABBV-519

    Up to 85 Days

  • Time to Cmax (Tmax) of ABBV-519

    Tmax of ABBV-519

    Up to 85 Days

  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-519

    t1/2 of ABBV-519

    Up to 85 Days

  • Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519

    AUCt of ABBV-519

    Up to 85 Days

  • Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519

    Percentage of participants with detection of ADAs for ABBV-519

    Up to 169 Days

  • Number of Participants with Adverse Events (AEs)

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

    Up to 425 Days

Study Arms (5)

Group 1: Dose A

EXPERIMENTAL

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

Drug: ABBV-519

Group 2: Dose B

EXPERIMENTAL

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

Drug: ABBV-519

Group 3: Dose C

EXPERIMENTAL

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

Drug: ABBV-519

Group 4: Dose D

EXPERIMENTAL

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

Drug: ABBV-519

Group 5: Dose E

EXPERIMENTAL

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

Drug: ABBV-519

Interventions

ABBV-519DRUG

Intravenous (IV) Infusion

Group 1: Dose AGroup 2: Dose BGroup 3: Dose C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals between 18 and 75 years of age inclusive at the time of Screening.
  • Minimum baseline B-cell count of 50 cells/mcL.
  • 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.
  • 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.

You may not qualify if:

  • Participants with a history of infection.
  • Participants with uncontrolled hypertension
  • 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.
  • \-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA Health West Medical Campus /ID# 282811

Los Angeles, California, 90095, United States

WITHDRAWN

Solace Research /ID# 279155

Tustin, California, 92780, United States

RECRUITING

Finlay Medical Research - Greenacres /ID# 278380

Greenacres City, Florida, 33467, United States

RECRUITING

Discovery Health Research Center /ID# 279691

Plantation, Florida, 33317, United States

RECRUITING

Epic Medical Research /ID# 279180

Red Oak, Texas, 75154, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742abbvieclinicaltrials@abbvie.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2026

First Posted

May 27, 2026

Study Start

May 28, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(5)