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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: Recruiting Phase 1 study of Systemic Lupus Erythematosus and Dry Eye Syndrome, sponsored by AbbVie.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
What NCT06977724 shows while recruiting
NCT06977724 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (91% lower).
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 lists 5 locations in 4 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06977724's enrollment target sits among peer trials
36 79th of 99 higher than 19 of 99 other Systemic Lupus Erythematosus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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