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 (AERIS)

March 30, 2026 updated by: Ventus Therapeutics U.S., Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bulgaria
      • Haskovo, Bulgaria
        • Recruiting
        • Investigative Site
      • Plovdiv, Bulgaria
        • Recruiting
        • Investigative Site
      • Sofia, Bulgaria
        • Recruiting
        • Investigative Site
  • France
      • Paris, France
        • Recruiting
        • Investigative Site
      • Toulouse, France
        • Recruiting
        • Investigative Site
  • Georgia
      • Tbilisi, Georgia
        • Recruiting
        • Investigative Site
  • Hungary
      • Szeged, Hungary
        • Recruiting
        • Investigative Site
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Investigative Site
      • Oświęcim, Poland
        • Recruiting
        • Investigative Site
      • Poznan, Poland
        • Recruiting
        • Investigative Site
      • Rzeszów, Poland
        • Recruiting
        • Investigative Site
      • Warsaw, Poland
        • Recruiting
        • Investigative Site
      • Wroclaw, Poland
        • Recruiting
        • Investigative Site
      • Śląskie, Poland
        • Recruiting
        • Investigative Site
  • South Africa
      • Pretoria, South Africa
        • Recruiting
        • Investigative Site
      • Stellenbosch, South Africa
        • Recruiting
        • Investigative Site
  • Spain
      • Badajoz, Spain
        • Recruiting
        • Investigative Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Investigative Site
    • Florida
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Investigative Site
      • DeBary, Florida, United States, 32713
        • Recruiting
        • Investigative Site
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Investigative Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Investigative Site
    • New York
      • Fairport, New York, United States, 14450
        • Recruiting
        • Investigative Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Investigative Site
    • Texas
      • Allen, Texas, United States, 75013
        • Recruiting
        • Investigative Site
      • Arlington, Texas, United States, 76012
        • Recruiting
        • Investigative Site
      • Colleyville, Texas, United States, 76034
        • Recruiting
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo is a tablet
Experimental: VENT-03
Drug: VENT-03
VENT-03 is a tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Percent change from baseline in interferon gene signature in the skin at Day 28
Baseline to End of Double-Blind Treatment (up to Day 28)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of VENT-03 on CLE disease severity
Time Frame: Baseline to End of Double-Blind Treatment (up to Day 28)
Percent change from baseline in CLASI-A score at Day 28
Baseline to End of Double-Blind Treatment (up to Day 28)
Evaluate effect of VENT-03 on CLE disease severity
Time Frame: Baseline to End of Double-Blind Treatment (up to Day 28)
Percentage of participants achieving CLASI-A 50 response (≥ 50% improvement in CLASI A score compared with baseline) at Day 28
Baseline to End of Double-Blind Treatment (up to Day 28)
Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy
Time Frame: Baseline to End of Treatment (up to Day 84)
Baseline to End of Treatment (up to Day 84)
Number of participants with at least one Treatment Emergent Adverse Event (TEAE) and/or Serious Adverse Event (SAE)
Time Frame: Baseline to End of Treatment (up to Day 84)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline to End of Treatment (up to Day 84)
Cmax: Maximum Observed Plasma Concentration for VENT-03
Time Frame: Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose
Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose
AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for VENT-03
Time Frame: Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose
Day 1 pre-dose and at multiple time points (up to 6 hours) post-dose; Day 28 pre-dose and post-dose; Day 56 and Day 84 pre-dose
Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to End of Treatment (up to Day 84)
Baseline to End of Treatment (up to Day 84)
Percentage of Participants with ≥ 1 Treatment Emergent Adverse Event (AE) leading to Treatment Discontinuation
Time Frame: Baseline to End of Treatment (up to Day 84)
Baseline to End of Treatment (up to Day 84)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ventus Therapeutics U.S., Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 10, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VENT-03-201
  • 2024-520098-12-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

As this study will enroll patients from the EU, the sponsor needs to consider that an IPD plan is compliant with GDPR. The sponsor needs to analyze and determine whether an IPD Plan can comply with GDPR based on plans and processes in place for the study in order to ensure legality and ethical data handling.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Systemic Lupus Erythematosus

Clinical Trials on VENT-03

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe