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)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
30 (estimated)
Sponsor
AbbVie · Industry
Who this trial is looking for
This trial is looking for adults with systemic lupus erythematosus or rheumatoid arthritis. Participants will receive treatment and attend regular check-ups to assess the effects and safety of the drug.
Are You a Good Fit for This Trial?
Rules you outActive neuropsychiatric SLEUncontrolled hypertension
You may be able to join if
I am between 18 and 75 years old.
I have been diagnosed with systemic lupus erythematosus or rheumatoid arthritis.
I have a minimum baseline B-cell count of 50 cells/mcL.
I have not responded well to at least one immunosuppressant therapy.
I have a hSLEDAI score of 4 or higher.
I have at least 6 swollen and 6 tender joints.
You may not be able to join if
I have a history of infection.
I have uncontrolled hypertension.
I have active neuropsychiatric symptoms related to systemic lupus erythematosus.
I have unstable glomerulonephritis.
I have RA overlap syndromes like systemic lupus erythematosus.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 asce…
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 Locations
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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 crit…
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.
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