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)

Study Identifier
M25-989
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Lupus (Systemic Lupus Erythematosus (SLE))
  • Rheumatoid Arthritis
  • Study Drug
  • ABBV-519
  • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 75 Years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    UCLA Health West Medical Campus /ID# 282811
    Los Angeles, California, United States, 90095
    Status
    Withdrawn
    Location
    Solace Research /ID# 279155
    Tustin, California, United States, 92780
    Status
    Recruiting
    Location
    Finlay Medical Research - Greenacres /ID# 278380
    Greenacres City, Florida, United States, 33467
    Status
    Recruiting
    Location
    Discovery Health Research Center /ID# 279691
    Plantation, Florida, United States, 33317
    Status
    Recruiting
    Location
    Epic Medical Research /ID# 279180
    Red Oak, Texas, United States, 75154
    Status
    Recruiting