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Purpose

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and 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. ABBV-319 exhibits potential B cell depletion in SLE and SjD 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 or SjD. ABBV-319 is an investigational drug being developed for the treatment of SLE and SjD. Participants are placed in 1 of 6 groups called treatment arms. Each group receives a different dose of ABBV-319 depending on whether they have SLE or SjD. Around 36 adult participants with SLE or SjD will be enrolled at approximately 10 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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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 - Presence of 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.

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ABBV-319 Group 1: SLE Participants 		Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.
  • Drug: ABBV-319
    Intravenous (IV) Infusion
Experimental
ABBV-319 Group 2: SLE Participants 		SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.
  • Drug: ABBV-319
    Intravenous (IV) Infusion
Experimental
ABBV-319 Group 3: SLE Participants 		SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.
  • Drug: ABBV-319
    Intravenous (IV) Infusion
Experimental
ABBV-319 Group 4: SLE Participants 		SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.
  • Drug: ABBV-319
    Intravenous (IV) Infusion
Experimental
ABBV-319 Group 5: SjD Participants 		Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
  • Drug: ABBV-319
    Intravenous (IV) Infusion
Experimental
ABBV-319 Group 6: SjD Participants 		SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.
  • Drug: ABBV-319
    Intravenous (IV) Infusion

Recruiting Locations

Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836
Tampa 4174757, Florida 4155751 33606

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.