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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 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.

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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.

Conditions Studied

Systemic Lupus Erythematosus SLE SLE (Systemic Lupus) Cutaneous Lupus Erythematosus (CLE) CLE

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

FieldValue
Enrollment Target 24 participants
Start Date 2025-12-03
Est. Completion 2026-09
Phase Phase 2

Sponsor

Ventus Therapeutics U.S.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07260877

The ClinicalTrials.gov registry entry for NCT07260877 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 24 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 (94% lower). The listed sponsor is Ventus Therapeutics U.S., which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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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.