Recruiting
Phase 2

VENT-03

Sponsor:

Ventus Therapeutics U.S., Inc.

Code:

NCT07260877

Conditions

Cutaneous Lupus Erythematosus (CLE)

Systemic Lupus Erythematosus

SLE

SLE (Systemic Lupus)

CLE

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VENT-03

Placebo

Study Details

Brief 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

Study ID

NCT07260877

Start date

Dec 3, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VENT-03

VENT-03

placebo comparator: Placebo

Placebo

Interventions

VENT-03

VENT-03 is a tablet

Placebo

Placebo is a tablet

Primary outcome measure

  • Evaluate the effect of VENT-03 on the interferon gene signature in the skin [ Time Frame: Baseline to End of Double-Blind Treatment (up to Day 28) ]

Central Contacts and Locations

Central contacts

VENT-03-201 Clinical Services

857-702-2273medinfo@ventustx.com

Locations

Investigative Site

Recruiting

Beverly Hills, California, United States, 90211

Investigative Site

Recruiting

Clearwater, Florida, United States, 33765

Investigative Site

Recruiting

DeBary, Florida, United States, 32713

Investigative Site

Recruiting

Miami, Florida, United States, 33133

Investigative Site

Recruiting

Tampa, Florida, United States, 33606

Investigative Site

Recruiting

Indianapolis, Indiana, United States, 46250

Investigative Site

Recruiting

Flint, Michigan, United States, 48439

Investigative Site

Recruiting

Troy, Michigan, United States, 48084

Investigative Site

Recruiting

Saint Joseph, Missouri, United States, 64506

Investigative Site

Recruiting

Albuquerque, New Mexico, United States, 87102

Investigative Site

Recruiting

Fairport, New York, United States, 14450

Investigative Site

Recruiting

Memphis, Tennessee, United States, 38119

Investigative Site

Recruiting

Allen, Texas, United States, 75013

Investigative Site

Recruiting

Arlington, Texas, United States, 76012

Investigative Site

Recruiting

Colleyville, Texas, United States, 76034

More Information

Sponsor

Ventus Therapeutics U.S., Inc.

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Keywords

  • CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03
  • cGAS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Ventus Therapeutics U.S., Inc. on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.