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NCT06977724 · ClinicalTrials.gov registry record · Phase 1

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)

A Phase 1 study of Systemic Lupus Erythematosus and Dry Eye Syndrome, sponsored by AbbVie.

Recruiting
Registry status
Phase 1
Development phase
36
Enrollment target
5
Study locations

NCT06977724 is a Phase 1 study of Systemic Lupus Erythematosus and Dry Eye Syndrome that is actively recruiting participants, run by AbbVie. The registered enrollment target is 36 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (91% lower). The trial reports 5 study locations across 4 states.

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The verdict

NCT06977724, a Phase 1 study of Systemic Lupus Erythematosus and Dry Eye Syndrome, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 1
Development phase
36 participants
Enrollment target
5
Study locations

Study Summary

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 Studied

Systemic Lupus Erythematosus Dry Eye Syndrome

Interventions

  • DRUG ABBV-319

Study Locations (5)

Florida

  • Life Clinical Trials /ID# 276050 - Margate
  • Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 275836 - Tampa

Tennessee

  • Private Practice - Dr. Ramesh C. Gupta I /ID# 275826 - Memphis

North Holland

  • Amsterdam UMC, locatie AMC /ID# 274286 - Amsterdam

Other

  • Universitair Medisch Centrum Utrecht /ID# 273398 - Utrecht

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2025-08-26
Est. Completion 2029-03
Phase Phase 1

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06977724

The ClinicalTrials.gov registry entry for NCT06977724 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (91% lower). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention - of which ABBV-319 is the first listed.

NCT06977724 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Florida, Tennessee, North Holland.

Frequently Asked Questions

What is clinical trial NCT06977724 about?

NCT06977724 is a clinical study titled "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)". 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 occ...

What is the current status of trial NCT06977724?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-08-26. Estimated completion is 2029-03.

What conditions does trial NCT06977724 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Dry Eye Syndrome.

What interventions are being tested in trial NCT06977724?

The interventions under investigation include: ABBV-319 (DRUG).

Who is sponsoring clinical trial NCT06977724?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06977724 being conducted?

This trial has 5 study locations across Florida, Tennessee, North Holland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.