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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

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

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Ventus Therapeutics U.S., Inc.

Last updated on ClinicalTrials.gov

October 5, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites