A Phase 1 interventional study of ABBV-519 and ABBV-519 in Systemic Lupus Erythematosus and Rheumatoid Arthritis, sponsored by AbbVie. Recruiting at 15 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
Among 477 studies in Lupus Erythematosus, Systemic with a site in United States — 88 open to participants now, 128 under way, 28 of them phase 3. Lupus Erythematosus, Systemic · United States.
Among the 477 studies in Lupus Erythematosus, Systemic with a site in United States, this one is the 282nd largest by planned enrollment of the 407 interventional ones that give a count, is one of 29 that started in 2026, is one of 104 in phase 1, reaches primary completion later than 94 of the 126 other live ones, and was the 470th registered.
1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →88 of the 477 studies in Lupus Erythematosus, Systemic with a site in United States are open now. Recruiting first, the newest first:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Sites in United States
Ages 9–85 · Healthy volunteers
National Human Genome Research Institute (NHGRI) · Sites in United States, Peru
Ages 18–115
EMD Serono Research & Development Institute, Inc. · Sites in United States
Ages 18–76
Fate Therapeutics · Sites in United States
Ages 18–70
NYU Langone Health · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 92 (32%) set no upper age limit and 162 (57%) stop at 75 or younger; 54 take children under 18; 34 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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477 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 130 · Phase 2 151 · Phase 3 75 · Phase 4 17
First in 1986; this study’s year is marked. 29 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 70 across the 407 interventional studies, 223 across the 67 observational. Of the 308 that completed or were terminated, 147 (48%) have results posted.
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264 of 477 have an industry lead sponsor. The 10 most frequent:
AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
AbbVie has 6 studies filed under Lupus Erythematosus, Systemic — fewer than ten, so there is no comparison to draw.
33 of the studies in Lupus Erythematosus, Systemic with a site in United States that are under way reach primary completion within a year, 7 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05672576Phase 3Viatris Innovation GmbHA Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus | 2026-12-31 |
| NCT05138133Phase 3AstraZenecaPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | 2027-02-23 |
| NCT05843643Phase 3AbbVieProgram to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus | 2027-03 |
| NCT05639114Phase 3Novartis PharmaceuticalsPhase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | 2027-03-26 |
| NCT05648500Phase 3Viatris Innovation GmbHA Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythematosus | 2027-03-31 |
Among the 477 studies in Lupus Erythematosus, Systemic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Inclusion Criteria:
Key Inclusion Criteria:
Inclusion Criteria for SLE Participants:
Inclusion Criteria for RA Participants:
Exclusion Criteria:
Key Exclusion Criteria:
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).
Exclusion for RA Participants:
-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single intravenous (IV) dose of ABBV-519
Drug: ABBV-519
Participants will receive a single intravenous (IV) dose of ABBV-519
Drug: ABBV-519
Participants will receive a single intravenous (IV) dose of ABBV-519
Drug: ABBV-519
Participants will receive a single subcutaneous (SC) dose of ABBV-519
Drug: ABBV-519
Participants will receive a single subcutaneous (SC) dose of ABBV-519
Drug: ABBV-519
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
Change from Baseline in B Cells in Blood
Change from baseline in B cells in blood.
Time frame: Up to 365 Days
Maximum Plasma Concentration (Cmax) of ABBV-519.
Cmax of ABBV-519
Time frame: Up to 85 Days
Time to Cmax (Tmax) of ABBV-519
Tmax of ABBV-519
Time frame: Up to 85 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519
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
AUCt of ABBV-519
Time frame: 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
Time frame: 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.
Time frame: Up to 425 Days
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jan 2029, 32 months after the start.
Of 107 industry-sponsored phase 1 interventional studies under Lupus Erythematosus, Systemic, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 35. This study's planned 32 months is above that.
Counting every sponsor, half of 146 studies reached it within 28 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Lupus Erythematosus, Systemic →