Shelby Research

Systemic Lupus Erythematosus + Sjögren’s Disease M25-433 study

Systemic Lupus Erythematosus + Sjögren’s Disease M25-433 study

NOW ENROLLING

Efficacy And Safety Of ABBV-319 In Adult Participants With Systemic Lupus Erythematosus (SLE) or Sjögren’s Disease (SjD)

Trial Details

Brief Summary: 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. SLE is a chronic, systemic autoimmune disease characterized by B cell hyperactivity and 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.

Condition or disease
Systemic Lupus Erythematosus (SLE)
Sjögren’s Disease (SjD)

Intervention/treatment
Biological: IV of ABBV-319

Phase
Phase 1

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

  • Has a concurrent clinically significant disease or clinically relevant laboratory abnormalities, or a history of any illness or medical condition that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.

  • 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.

*Other protocol-defined inclusion/exclusion criteria may apply


View Trial on ClinicalTrials.gov website: NCT06977724