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NCT05866861 · ClinicalTrials.gov registry record · Phase 1
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
A Phase 1 study of Systemic Lupus Erythematosus and SLE (Systemic Lupus), sponsored by Cugene.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 11
- Study locations
NCT05866861: Active Phase 1 study of Systemic Lupus Erythematosus and SLE (Systemic Lupus), sponsored by Cugene.
NCT05866861 is a Phase 1 study of Systemic Lupus Erythematosus and SLE (Systemic Lupus) that is active but no longer recruiting, run by Cugene. The registered enrollment target is 40 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (89% lower). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05866861, a Phase 1 study of Systemic Lupus Erythematosus and SLE (Systemic Lupus), is active but no longer recruiting, sponsored by Cugene.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 11
- Study locations
Study Summary
The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
Primary Outcome
To evaluate the safety and tolerability of multiple ascending doses (MAD) in participants with mild to moderate SLE.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CUG252
Study Locations (11)
Florida
- Site 1002 - Clearwater
- Site 1009 - Tampa
Ohio
- Site 1010 - Columbus
- Site 1005 - Middleburg Heights
Texas
- Site 1006 - Dallas
- Site 1004 - Mesquite
Alabama
- Site 1001 - Anniston
California
- Site 1011 - La Jolla
Georgia
- Site 1007 - Lawrenceville
Pennsylvania
- Site 1003 - Duncansville
Washington
- Site 1012 - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2025-04-01 |
| Phase | Phase 1 |
What the registry record for NCT05866861 still lists
NCT05866861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05866861 lists 11 locations in 8 states (Florida, Ohio, Texas).
Frequently Asked Questions
What is clinical trial NCT05866861 about?
NCT05866861 is a clinical study titled "A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus". The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus Erythematosus (SLE).
What is the current status of trial NCT05866861?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-04-24. Estimated completion is 2025-04-01.
What conditions does trial NCT05866861 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, SLE (Systemic Lupus), Autoimmune.
What interventions are being tested in trial NCT05866861?
The interventions under investigation include: Placebo (DRUG), CUG252 (DRUG).
Who is sponsoring clinical trial NCT05866861?
This trial is sponsored by Cugene, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05866861 being conducted?
This trial has 11 study locations across Alabama, California, Florida, Georgia, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Systemic Lupus Erythematosus
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Where NCT05866861's enrollment target sits among peer trials
40 75th of 99 higher than 22 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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