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NCT07260877 · ClinicalTrials.gov registry record · Phase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
A Phase 2 study of Systemic Lupus Erythematosus and SLE, sponsored by Ventus Therapeutics U.S..
- Recruiting
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT07260877: Recruiting Phase 2 study of Systemic Lupus Erythematosus and SLE, sponsored by Ventus Therapeutics U.S..
NCT07260877 is a Phase 2 study of Systemic Lupus Erythematosus and SLE that is actively recruiting participants, run by Ventus Therapeutics U.S.. The registered enrollment target is 24 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07260877, a Phase 2 study of Systemic Lupus Erythematosus and SLE, is actively recruiting participants, sponsored by Ventus Therapeutics U.S..
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to answer are: * Does VENT-03 affect the activity and severity of CLE? * What side effects do participants have when taking VENT-03? Researchers will compare VENT-03 to a placebo (a look-alike substance that contains no drug) to see if VENT-03 works to treat patients with CLE. Participants will: * Take VENT-03 or a placebo e for 4 weeks, then all participants will switch to VENT-03 for another 8 weeks; * Visit the clinic once a month for checkups and tests.
Primary Outcome
Percent change from baseline in interferon gene signature in the skin at Day 28
Conditions Studied
Interventions
- DRUG Placebo
- DRUG VENT-03
Study Locations (20)
Other
- Investigative Site - Haskovo
- Investigative Site - Plovdiv
- Investigative Site - Sofia
- Investigative Site - Paris
- Investigative Site - Toulouse
- Investigative Site - Tbilisi
- Investigative Site - Szeged
- Investigative Site - Bialystok
- Investigative Site - Oświęcim
- Investigative Site - Poznan
Florida
- Investigative Site - Clearwater
- Investigative Site - DeBary
- Investigative Site - Tampa
Texas
- Investigative Site - Allen
- Investigative Site - Arlington
- Investigative Site - Colleyville
California
- Investigative Site - Beverly Hills
Missouri
- Investigative Site - Saint Joseph
New York
- Investigative Site - Fairport
Tennessee
- Investigative Site - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-12-03 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT07260877 shows while recruiting
NCT07260877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07260877 names 20 study sites across 7 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT07260877 about?
NCT07260877 is a clinical study titled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus". The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE). Another goal is to learn about the safety of VENT-03 and how it is processed by the body. The main questions it aims to ...
What is the current status of trial NCT07260877?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2025-12-03. Estimated completion is 2026-09.
What conditions does trial NCT07260877 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus), Cutaneous Lupus Erythematosus (CLE), CLE.
What interventions are being tested in trial NCT07260877?
The interventions under investigation include: Placebo (DRUG), VENT-03 (DRUG).
Who is sponsoring clinical trial NCT07260877?
This trial is sponsored by Ventus Therapeutics U.S., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07260877 being conducted?
This trial has 20 study locations across California, Florida, Missouri, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07260877's enrollment target sits among peer trials
24 88th of 99 higher than 12 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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