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Study of VENT-03 tablets in adults with active cutaneous lupus erythematosus with or without systemic lupus erythematosus

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Cutaneous Lupus Erythematosus, a skin condition that causes rashes and lesions, which may occur with or without Systemic Lupus Erythematosus, an autoimmune disease affecting multiple organs. The research evaluates a new medication called VENT-03, which is taken as tablets by mouth.

The purpose of this research is to determine how well VENT-03 works in reducing the severity of skin symptoms in adults with active cutaneous lupus. During the study, participants will receive either VENT-03 tablets or placebo tablets that look identical but contain no active medication. After the initial phase where neither participants nor doctors know who receives which treatment, the study continues with an open-label extension where all participants receive the active medication.

The study will measure how the skin symptoms change over time, particularly focusing on the improvement in skin lesions. Throughout the study, participants will undergo various health assessments to monitor their response to treatment and ensure their safety. The medication's levels in the blood will also be measured to understand how the body processes it.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    You will undergo initial assessment to confirm eligibility for the study

    Your cutaneous lupus (skin lupus) condition will be evaluated

    Basic health measurements including weight (must be between 40-110 kg) will be taken

    You must be between 18 and 70 years of age to participate

  2. Step 2

    Treatment phase - Day 1

    You will be randomly assigned to receive either VENT-03 tablets or placebo tablets (tablets that look identical but contain no active medication)

    The tablets will be taken by mouth

    Neither you nor your doctor will know which treatment you are receiving

  3. Step 3

    Monitoring period - Day 1 to Day 28

    Your skin condition will be regularly assessed using the CLASI-A score (a measure of lupus skin disease activity)

    Blood samples will be taken to measure VENT-03 levels in your body

    You will undergo regular health checks including:

    - Physical examinations

    - Heart monitoring (ECG)

    - Vital signs measurements

    - Laboratory safety tests

    A small skin sample (biopsy) will be taken for analysis

  4. Step 4

    Final assessment - Day 28

    The main assessment will measure changes in your skin condition compared to the start of the study

    All safety measurements will be repeated

    Any side effects that occurred during the study will be documented

Who can join the trial?

8 criteria

  • Age between 18 and 70 years old
  • Body weight between 40 to 110 kg (88 to 242 lbs)
  • Must provide written informed consent to participate in the study
  • Diagnosed with cutaneous lupus (a skin condition causing rash and inflammation) at the screening visit
  • Must be willing and able to follow all study procedures and attend all required visits for the duration of the study
  • For women who can become pregnant: Must use effective birth control starting at least 30 days before the study medication and continuing until 30 days after the last dose
  • For men who can father children:
    • Must use effective birth control starting 30 days before the study medication and continuing until 90 days after the last dose
    • Must not donate sperm for 90 days after receiving the last dose of study medication

Who cannot join the trial?

14 criteria

  • Active or chronic infections, including tuberculosis (TB) or hepatitis B
  • History of severe allergic reactions to medications
  • Presence of other autoimmune conditions besides Cutaneous Lupus
  • Current pregnancy or breastfeeding
  • Use of other investigational drugs within 30 days before starting the study
  • Significant heart, liver, or kidney problems
  • Active cancer or history of cancer in the past 5 years (except successfully treated skin cancer)
  • Uncontrolled high blood pressure
  • Major surgery within 8 weeks before starting the study
  • History of substance abuse within the past year
  • Mental health conditions that could interfere with study participation
  • Use of medications that could interact with the study drug
  • Blood test results outside of acceptable ranges
  • Unable to follow study procedures or attend scheduled visits
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Investigated drugs

VENT-03 is an investigational medication being studied for the treatment of cutaneous lupus erythematosus (skin lupus) in adults, including patients who may also have systemic lupus erythematosus. The medication is being tested to see if it can reduce the severity of skin symptoms associated with lupus. This is an experimental drug that is currently in Phase 2a of clinical development, which means it is still being evaluated for both safety and effectiveness.

What is already known about the treatment

VENT-03 - An investigational medication currently being studied in Phase 2a clinical trials for the treatment of Cutaneous Lupus Erythematosus (CLE), both with and without Systemic Lupus Erythematosus. This novel therapeutic agent is being evaluated for its effectiveness in reducing disease severity and activity in skin manifestations of lupus, as measured by the CLASI-A scoring system. While the specific mechanism of action and form of administration are not publicly disclosed in the current trial documentation, the medication is being tested against placebo in a randomized, double-blind study design, suggesting it may have immunomodulatory properties targeting the autoimmune components of lupus skin disease.

Investigated diseases

Cutaneous Lupus Erythematosus – A chronic autoimmune condition that affects the skin, causing inflammation and rash. The condition typically presents as red, thick, and scaly patches on sun-exposed areas of the skin, particularly the face, neck, and scalp. These patches may be triggered or worsened by exposure to sunlight and can become more prominent during disease flares. The condition can cause skin changes including redness, scaling, and scarring, and may appear as disc-shaped lesions that can be lighter in the center. In some cases, the affected skin may develop permanent scarring or changes in pigmentation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520098-12-00Protocol codeVENT-03-201Estimated enrolment23 patientsSponsorVentus Therapeutics U.S. Inc.

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