NCT07260877

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ventus Therapeutics U.S., Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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

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

Interventions

Type	Name	Description
DRUG	VENT-03	VENT-03 is a tablet
DRUG	Placebo	Placebo is a tablet

Timeline

• Start date: 2025-12-03
• Primary completion: 2026-07-01
• Completion: 2026-09-01
• First posted: 2025-12-03
• Last updated: 2026-04-06

Locations

27 sites across 8 countries: United States, Bulgaria, France, Georgia, Hungary, Poland, South Africa, Spain

Regulatory

• FDA-regulated drug study