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New pill VENT-03 aims to calm lupus skin flares

NCT ID NCT07260877

Disease control Sponsor: Ventus Therapeutics U.S., Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tests an experimental tablet called VENT-03 for people with active cutaneous lupus erythematosus (CLE), a condition causing painful skin rashes. Twenty-four adults will take either VENT-03 or a placebo for 4 weeks, then everyone gets VENT-03 for 8 more weeks. Researchers will check if the drug reduces skin inflammation and what side effects occur.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VENT-03 (a tablet)
What this could lead to
If it works, this could point toward a new treatment option for people with cutaneous lupus, reducing skin inflammation and severity.
What could go wrong
This is a very early, small Phase 2a trial with only 24 participants. The drug may not prove effective or safe, and results may not apply to everyone with lupus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

congenital lobar emphysema cutaneous lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CLE Cutaneous lupus erythematosus (CLE) SLE SLE (systemic lupus) Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    32 sites in 8 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Investigative Site

    RECRUITING

    Pretoria, South Africa

  • Investigative Site

    RECRUITING

    Somerset West, South Africa

  • Investigative Site

    RECRUITING

    Badajoz, Spain

  • Investigative Site

    RECRUITING

    Madrid, Spain

  • Investigative Site

    RECRUITING

    Warsaw, Poland

  • Investigative Site

    RECRUITING

    Wroclaw, Poland

  • Investigative Site

    RECRUITING

    Durban, South Africa

  • Investigative Site

    RECRUITING

    Śląskie, Poland

  • Investigative Site

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Investigative Site

    RECRUITING

    Clearwater, Florida, 33765, United States

  • Investigative Site

    RECRUITING

    DeBary, Florida, 32713, United States

  • Investigative Site

    RECRUITING

    Tampa, Florida, 33606, United States

  • Investigative Site

    RECRUITING

    Indianapolis, Indiana, 46250, United States

  • Investigative Site

    RECRUITING

    Flint, Michigan, 48439, United States

  • Investigative Site

    RECRUITING

    Troy, Michigan, 48084, United States

  • Investigative Site

    RECRUITING

    Saint Joseph, Missouri, 64506, United States

  • Investigative Site

    RECRUITING

    Fairport, New York, 14450, United States

  • Investigative Site

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Investigative Site

    RECRUITING

    Allen, Texas, 75013, United States

  • Investigative Site

    RECRUITING

    Arlington, Texas, 76012, United States

  • Investigative Site

    RECRUITING

    Colleyville, Texas, 76034, United States

  • Investigative Site

    RECRUITING

    Haskovo, Bulgaria

  • Investigative Site

    RECRUITING

    Plovdiv, Bulgaria

  • Investigative Site

    RECRUITING

    Sofia, Bulgaria

  • Investigative Site

    RECRUITING

    Paris, France

  • Investigative Site

    RECRUITING

    Toulouse, France

  • Investigative Site

    RECRUITING

    Tbilisi, Georgia

  • Investigative Site

    RECRUITING

    Szeged, Hungary

  • Investigative Site

    RECRUITING

    Bialystok, Poland

  • Investigative Site

    RECRUITING

    Oświęcim, Poland

  • Investigative Site

    RECRUITING

    Poznan, Poland

  • Investigative Site

    RECRUITING

    Rzeszów, Poland

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