Systemic Lupus ErythematosusPhase 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 study testing ABBV-519 in people with Systemic Lupus Erythematosus and Rheumatoid Arthritis, run by AbbVie at 15 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Rheumatoid Arthritis
- What is being tested?
- ABBV-519
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 28 May 2026to Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
United States12 sites, 12 recruiting
- Recruiting
Pinnacle Research Group /ID# 278677
Anniston, Alabama, 36207
- Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 279292
Clearwater, Florida, 33765
- Recruiting
Finlay Medical Research - Greenacres /ID# 278380
Greenacres City, Florida, 33467
- Recruiting
Accurate Clinical Research - Houston /ID# 278382
Houston, Texas, 77089-6142
- Recruiting
West Tennessee Research Institute - Jackson /ID# 284561
Jackson, Tennessee, 38305
- Recruiting
Clinical Research of Osceola /ID# 278374
Kissimmee, Florida, 34741
- Recruiting
Allied Biomedical Research Institute /ID# 284408
Miami, Florida, 33155
- Recruiting
Advanced Quality Medical Research /ID# 279147
Orland Park, Illinois, 60462
- Recruiting
Discovery Health Research Center /ID# 279691
Plantation, Florida, 33317
- Recruiting
Epic Medical Research /ID# 279180
Red Oak, Texas, 75154
- Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130
Tampa, Florida, 33606
- Recruiting
Solace Research /ID# 279155
Tustin, California, 92780
Japan3 sites, 3 recruiting
- Recruiting
Institute of Science Tokyo Hospital /ID# 279648
Bunkyo-ku, Tokyo, 113-8519
- Recruiting
Japan Community Healthcare Organization Chukyo Hospital /ID# 279611
Nagoya, Aichi-ken, 457-8510
- Recruiting
National Center for Global Health and Medicine /ID# 281191
Shinjuku-ku, Tokyo, 162-8655
About this study
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)
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.
Read more
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
- Being tested
- ABBV-519
- Keywords
- Systemic Lupus Erythematosus, Rheumatoid Arthritis
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-519Drug
Intravenous (IV) Infusion
ABBV-519Drug
Subcutaneous (SC) Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Dose A | Experimental | Participants will receive a single intravenous (IV) dose of ABBV-519 Receives: Drug: ABBV-519 |
| Group 2: Dose B | Experimental | Participants will receive a single intravenous (IV) dose of ABBV-519 Receives: Drug: ABBV-519 |
| Group 3: Dose C | Experimental | Participants will receive a single intravenous (IV) dose of ABBV-519 Receives: Drug: ABBV-519 |
| Group 4: Dose D | Experimental | Participants will receive a single subcutaneous (SC) dose of ABBV-519 Receives: Drug: ABBV-519 |
| Group 5: Dose E | Experimental | Participants will receive a single subcutaneous (SC) dose of ABBV-519 Receives: Drug: ABBV-519 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in B Cells in Blood
Change from baseline in B cells in blood.
Measured: Up to 365 Days
Maximum Plasma Concentration (Cmax) of ABBV-519.
Cmax of ABBV-519
Measured: Up to 85 Days
Time to Cmax (Tmax) of ABBV-519
Tmax of ABBV-519
Measured: Up to 85 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
t1/2 of ABBV-519
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 425 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start28 May 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607964
- Sponsor's protocol ID
- M25-989
- Status last verified
- Oct 2026
- First submitted
- 20 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No