Rheumatoid Arthritis, Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Brief 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.
Interventions
DRUGABBV-519
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in B Cells in Blood | Up to 365 Days | Change from baseline in B cells in blood. |
| Maximum Plasma Concentration (Cmax) of ABBV-519. | Up to 85 Days | Cmax of ABBV-519 |
| Time to Cmax (Tmax) of ABBV-519 | Up to 85 Days | Tmax of ABBV-519 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-519 | Up to 85 Days | t1/2 of ABBV-519 |
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519 | Up to 85 Days | AUCt of ABBV-519 |
| Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519 | Up to 169 Days | Percentage of participants with detection of ADAs for ABBV-519 |
| Number of Participants with Adverse Events (AEs) | Up to 425 Days | 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. |
Countries
Japan, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed