Dry Eye Syndrome, Systemic Lupus Erythematosus
Conditions
Keywords
Dry Eye Syndrome, Systemic Lupus Erythematosus, ABBV-319
Brief summary
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity. Sjorgren's disease (SjD) is a chronic, multisystem autoimmune disease characterized by lacrimal and salivary gland inflammation, with resultant dryness of the eyes and mouth and occasional glandular enlargement and Rheumatoid arthritis (RA) is a long-lasting autoimmune disease that causes the body's immune system to attack itself. RA targets the body's joints, causing inflammation (swelling, pain, and redness). ABBV-319 exhibits potential B cell depletion in SLE, SjD and RA which are characterized by B cell hyperactivity. The purpose of this study is to assess the pharmacokinetics, safety, and efficacy of ABBV-319 in adult participants with SLE, SjD and RA. ABBV-319 is an investigational drug being developed for the treatment of SLE , SjD and RA. Participants are placed in 1 of 8 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE, SjD or RA. Around 48 adult participants with SLE, SjD or RA will be enrolled at approximately up to 17 sites worldwide. Participants will receive 2 doses of IV ABBV-319 21 days apart and will be followed for up to 343 days. 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-319
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Systemic Lupus Erythematosus (SLE) Population - Clinical diagnosis of SLE at least 6 months prior to Screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College Of Rheumatology (ACR) classification criteria for SLE and a positive antinuclear antibody (ANA) \>= 1:80 drawn at Screening. * SLE Population - Anti-double stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome Ag A (SSA) Abs above the upper limit of normal (ULN). * Sjogren's Disease (SjD) Population - Primary diagnosis of SjD at least 6 months prior to Screening as defined by the ACR/EULAR 2016 Criteria. * SjD Population - EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) \>= 5 at Screening. * SjD Population - EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) \>= 5 at Screening. * Rheumatoid Arthritis (RA) Population - Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA. * RA Population - Rheumatoid Factor (RF) or ACPA above the ULN at Screening. * RA Population - Confirmation of at least moderate disease activity at Screening, defined by both of the following disease activity criteria: * Presence of at least 6 swollen and 6 tender joints at Screening using the 68 (tender)/66 (swollen) joint count. * hs-CRP ≥3 mg/L.
Exclusion criteria
* History of infection as defined in the protocol. * Any of the medical diseases or disorders listed in the protocol. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the 6 months prior to Screening. * Any planned elective surgery that would impact study procedures or assessments through the completion of the Day 365 assessments. * Any clinically significant ECG abnormalities at Screening. * RA-Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to approximately 400 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. |
| Change from Baseline in B Cells in Blood and Tissue | Up to approximately 400 days | Change from baseline in B cells in blood and tissue. |
| Maximum Plasma Concentration (Cmax) of ABBV-319 | Up to approximately 400 days | Cmax of ABBV-319. |
| Time to Cmax (Tmax) of ABBV-319 | Up to approximately 400 days | Tmax of ABBV-319. |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 | Up to approximately 400 days | t1/2 of ABBV-319. |
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-319 | Up to approximately 400 days | AUCt of ABBV-319. |
| Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-319 | Up to approximately 400 days | Percentage of participants with detection of ADAs for ABBV-319. |
| Percentage of Participants with Detection of Neutralizing Antibodies (nAbs) for ABBV-319 | Up to approximately 400 days | Percentage of participants with detection of nAbs for ABBV-319. |
Countries
France, Netherlands, United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed