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Clinical Trials in the USA / NCT07260877
Recruiting 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

NCT07260877 · tracked via the Priya Life Science USA tracker
Sponsor
Ventus Therapeutics U.S., Inc.
Phase
Phase 2
Started
2025-12-03
Last updated
2026-07-27

Condition(s) studied

Cutaneous Lupus Erythematosus (CLE)Systemic Lupus ErythematosusSLESLE (Systemic Lupus)CLE

Investigational drug(s) / intervention(s)

VENT-03Placebo

VENT-03: VENT-03 is a tablet

Placebo: Placebo is a tablet

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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Key Inclusion Criteria: * Cutaneous lupus: * CLASI-A score ≥8; * At least 1 active discoid lupus erythematosus (DLE) lesion, OR at least 1 active subacute CLE lesion * If participant has previous SLE diagnosis: * Positive antinuclear antibody test at Screening by immunofluorescent assay at the central laboratory with titer ≥ 1:80; * Meets the American College of Rheumatology/ European Alliance of Associations for Rheumatology 2019 criteria for SLE; and * Currently receiving at least one of the specified SLE medication treatments, at stable doses. Key Exclusion Criteria: * Meet protocol-specified infection or lab criteria; any other laboratory test results that, in the investigator's opinion, might place participant at unacceptable risk for participating in this study; * Moderate or severe liver impairment as classified by the Child-Pugh criteria (categories B and C); * Has drug-induced lupus, rather than 'idiopathic' lupus; * History of, or current, inflammatory joint or skin disease other than SLE and cutaneous lupus; * Diagnosis of select potentially confounding autoimmune disorders * Active severe or unstable neuropsychiatric SLE; * Hospitalization for a severe lupus flare in the past 3 months, or active severe SLE-driven disease, including lupus nephritis, for which in the opinion of the PI the protocol-specified SOC is insufficient; * History of or current diagnosis of anti-phospholipid syndrome; * History of any non-lupus disease that has required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the last 24 weeks prior to Day 1; * Meets protocol specified medical history of infectious diseases and infections and/or opportunistic infection requiring hospitalization or parenteral antimicrobial treatment within specified timeframes; * Cancer screening results suspicious of malignancy or history of cancer within time specified with exceptions for curative therapy for squamous or basil cell carcinoma and cervical cancer in situ; and * Meets protocol specified exclusions related to concomitant medications.

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
Investigative Site Beverly Hills California Recruiting
Investigative Site Clearwater Florida Recruiting
Investigative Site DeBary Florida Recruiting
Investigative Site Tampa Florida Recruiting
Investigative Site Indianapolis Indiana Recruiting
Investigative Site Flint Michigan Recruiting
Investigative Site Troy Michigan Recruiting
Investigative Site Saint Joseph Missouri Recruiting
Investigative Site Fairport New York Recruiting
Investigative Site Memphis Tennessee Recruiting
Investigative Site Allen Texas Recruiting
Investigative Site Arlington Texas Recruiting
Investigative Site Colleyville Texas Recruiting
Investigative Site Haskovo Bulgaria Recruiting
Investigative Site Plovdiv Bulgaria Recruiting
Investigative Site Sofia Bulgaria Recruiting
Investigative Site Paris France Recruiting
Investigative Site Toulouse France Recruiting
Investigative Site Tbilisi Georgia Recruiting
Investigative Site Szeged Hungary Recruiting
Investigative Site Bialystok Poland Recruiting
Investigative Site Oświęcim Poland Recruiting
Investigative Site Poznan Poland Recruiting
Investigative Site Rzeszów Poland Recruiting
Investigative Site Śląskie Poland Recruiting
Investigative Site Warsaw Poland Recruiting
Investigative Site Wroclaw Poland Recruiting
Investigative Site Durban South Africa Recruiting
Investigative Site Pretoria South Africa Recruiting
Investigative Site Somerset West South Africa Recruiting
Investigative Site Badajoz Spain Recruiting
Investigative Site Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07260877 on ClinicalTrials.gov ↗ ← All trials in the USA