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RecruitingPhase 1

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, 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ABBV-519 in adults with moderate lupus (SLE) or rheumatoid arthritis (RA). It checks side effects, how the drug moves through the body, and how it works when given into a vein or under the skin. The study lasts about 425 days and includes regular clinic or hospital visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 18 to 75 years old.
  • You must have at least 50 B cells per microliter of blood. B cells are part of your immune system.
  • For lupus: You must have a lupus diagnosis that meets the study’s rules and certain positive blood tests for antibodies, which are immune system proteins.
  • For lupus: Your disease activity score must be at least 4 under the study’s scoring rules.
  • For lupus: At least one drug that lowers immune system activity must not have worked well enough after at least 3 months of use.
  • For RA: You must have an RA diagnosis that meets the study’s rules and a high level of at least one of two antibodies linked to RA.
  • For RA: You must have at least 6 swollen joints and 6 tender joints, plus an hs-CRP blood test result of at least 3 mg/L. This test measures inflammation.
  • For RA: At least one standard disease-modifying drug and at least one biologic or targeted disease-modifying drug must not have worked. These drugs must be from different drug groups.

Who can't join

  • You have a history of infection.
  • You have high blood pressure that is not controlled.
  • For lupus: You have active lupus affecting the brain or mental health, or had signs of it in the past 6 months. Lupus headaches are allowed.
  • For lupus: You have active class III or IV kidney inflammation that is unstable or getting worse.
  • For lupus: You also have another overlapping immune disease, such as RA, Sjogren’s disease, scleroderma, muscle inflammation, or mixed connective tissue disease.
  • For RA: You have a history of an overlapping immune disease, such as lupus, Sjogren’s disease, scleroderma, mixed connective tissue disease, or muscle inflammation.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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 sites (11)

AL

CA

FL

IL

TN

TX