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) and Sjogren's Disease (SjD)

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Dry Eye Syndrome; Systemic Lupus Erythematosus

Treatments: Drug: ABBV-319

Study type: Interventional

Funder types: Industry

Identifiers

NCT06977724

M25-433

2024-519157-10 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 6 patient groups

ABBV-319 Group 1: SLE Participants

Experimental group

Description:

Systemic Lupus Erythematosus (SLE) participants will receive 2 doses of ABBV-319 Dose A 21 days apart.

Treatment:

Drug: ABBV-319

ABBV-319 Group 2: SLE Participants

Experimental group

Description:

SLE participants will receive 2 doses of ABBV-319 Dose B 21 days apart.

Treatment:

Drug: ABBV-319

ABBV-319 Group 3: SLE Participants

Experimental group

Description:

SLE participants will receive 2 doses of ABBV-319 Dose C 21 days apart.

Treatment:

Drug: ABBV-319

ABBV-319 Group 4: SLE Participants

Experimental group

Description:

SLE participants will receive 2 doses of ABBV-319 Dose D 21 days apart.

Treatment:

Drug: ABBV-319

ABBV-319 Group 5: SjD Participants

Experimental group

Description:

Sjogren's disease (SjD) participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

Treatment:

Drug: ABBV-319

ABBV-319 Group 6: SjD Participants

Experimental group

Description:

SjD participants will receive 2 doses of ABBV-319 Dose TBD 21 days apart.

Treatment:

Drug: ABBV-319