A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions of ABBV-319 in Adult Participants With Systemic Lupus Erythematosus (SLE), Sjogren's Disease (SjD) and Rheumatoid Arthritis (RA)
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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 Exclusion Criteria - History of RA overlap syndromes, including but not limited to, SLE, SjD, scleroderma, mixed connective tissue disease, or polymyositis.
Primary outcome measure(s)
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.
Trial sites (11)
Facility
City
Region
Status
Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 278239
Avon Park
Florida
Not Yet Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 275834
Clearwater
Florida
Not Yet Recruiting
Life Clinical Trials - Colonial Drive - Margate /ID# 276050
Margate
Florida
Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa
Florida
Recruiting
Advanced Quality Medical Research /ID# 278462
Orland Park
Illinois
Recruiting
Private Practice - Dr. Ramesh C. Gupta /ID# 275826
Memphis
Tennessee
Recruiting
Integrative Rheumatology of South Texas - Harlingen /ID# 276458
Harlingen
Texas
Recruiting
Les Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre /ID# 272692
Strasbourg
Alsace
Recruiting
CHU de Montpellier - Hopital Lapeyronie /ID# 279892
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
