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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)

ConditionsSystemic Lupus ErythematosusRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAbbVie

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ABBV-519

    Drug

    Intravenous (IV) Infusion

  • ABBV-519

    Drug

    Subcutaneous (SC) Injection

Treatment groups

30 Participants
are divided into 5 treatment groups
Group A: Group 1: Dose AExperimental treatment 1 intervention
Group B: Group 2: Dose BExperimental treatment 1 intervention
Group C: Group 3: Dose CExperimental treatment 1 intervention
Group D: Group 4: Dose DExperimental treatment 1 intervention
Group E: Group 5: Dose EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in B Cells in Blood

Change from baseline in B cells in blood.

Time frame
Up to 365 Days
2

Maximum Plasma Concentration (Cmax) of ABBV-519.

Cmax of ABBV-519

Time frame
Up to 85 Days
3

Time to Cmax (Tmax) of ABBV-519

Tmax of ABBV-519

Time frame
Up to 85 Days
4

Terminal Phase Elimination Half-Life (t1/2) of ABBV-519

t1/2 of ABBV-519

Time frame
Up to 85 Days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbbVie

Lead sponsor

Source ClinicalTrials.gov
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