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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ClinHouse Centrum Medyczne Zabrze Poland
Hospital Clinico San Carlos Madrid Spain
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Diagnostics And Consultancy Center Sveti Georgi EOOD Haskovo Bulgaria
Qualiclinic Kft. Budapest Hungary
Clinical Research Group Sp. z o.o. Warsaw Poland
Diagnostics And Consultancy Center Pulmed EOOD Plovdiv Bulgaria
Synexus Polska Sp. z o.o. Poznan Poland
Hopital Beaujon Clichy France
University Of Szeged Szeged Hungary
ASMC – IPSMC – Skin And Venereal Diseases Sofia Bulgaria
NZOZ Lecznica Mak Med s.c. Nadarzyn Poland
prof. MUDr. Petr Arenberger, DrSc. MBA Prague Czechia
Plazvonm Parohdxh Lyhtrgts Pudk Db Hmy Max Pqadx Hhiwxc Poznan Poland
Hxvracuc Uzkevgnxbqwwj Dc Bpiamdp Badajoz Spain
Nbbw Syrcwckj Oslxmrw Dierpvqgmrktzow Dlxege Bialystok Poland
Izejgpqp Zilxeog Do Bzovtvxhrsvakeiws Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
01.09.2025
Czechia Czechia
Not recruiting
01.09.2025
France France
Recruiting
01.09.2025
Hungary Hungary
Not yet recruiting
01.09.2025
Poland Poland
Recruiting
01.09.2025
Spain Spain
Recruiting
01.09.2025

Trial locations

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.

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 ID:
2024-520098-12-00
Protocol code:
VENT-03-201
Trial Phase:
Therapeutic exploratory (Phase II)

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