NCT07260877

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 e 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
4mo left

Started Dec 2025

Shorter than P25 for phase_2

Geographic Reach
8 countries

27 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2025Sep 2026

First Submitted

Initial submission to the registry

November 10, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

December 3, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 11, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

November 10, 2025

Last Update Submit

March 10, 2026

Conditions

Systemic Lupus ErythematosusSLESLE (Systemic Lupus)CLECutaneous Lupus Erythematosus (CLE)

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect of VENT-03 on the interferon gene signature in the skin

    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 Outcomes (8)

  • Evaluate the effect of VENT-03 on CLE disease severity

    Baseline to End of Double-Blind Treatment (up to Day 28)

  • Evaluate effect of VENT-03 on CLE disease severity

    Baseline to End of Double-Blind Treatment (up to Day 28)

  • Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy

    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)

    Baseline to End of Treatment (up to Day 84)

  • Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)

    Baseline to End of Treatment (up to Day 84)

  • +3 more secondary outcomes

Study Arms (2)

VENT-03

EXPERIMENTAL

VENT-03

Drug: VENT-03

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PlaceboDRUG

Placebo is a tablet

Placebo
VENT-03DRUG

VENT-03 is a tablet

VENT-03

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Investigative Site

Beverly Hills, California, 90211, United States

RECRUITING

Investigative Site

Clearwater, Florida, 33765, United States

RECRUITING

Investigative Site

DeBary, Florida, 32713, United States

RECRUITING

Investigative Site

Tampa, Florida, 33606, United States

RECRUITING

Investigative Site

Saint Joseph, Missouri, 64506, United States

RECRUITING

Investigative Site

Fairport, New York, 14450, United States

RECRUITING

Investigative Site

Memphis, Tennessee, 38119, United States

RECRUITING

Investigative Site

Allen, Texas, 75013, United States

RECRUITING

Investigative Site

Arlington, Texas, 76012, United States

RECRUITING

Investigative Site

Colleyville, Texas, 76034, United States

RECRUITING

Investigative Site

Haskovo, Bulgaria

RECRUITING

Investigative Site

Plovdiv, Bulgaria

RECRUITING

Investigative Site

Sofia, Bulgaria

RECRUITING

Investigative Site

Paris, France

RECRUITING

Investigative Site

Toulouse, France

RECRUITING

Investigative Site

Tbilisi, Georgia

RECRUITING

Investigative Site

Szeged, Hungary

RECRUITING

Investigative Site

Bialystok, Poland

RECRUITING

Investigative Site

Oświęcim, Poland

RECRUITING

Investigative Site

Poznan, Poland

RECRUITING

Investigative Site

Rzeszów, Poland

RECRUITING

Investigative Site

Śląskie, Poland

RECRUITING

Investigative Site

Warsaw, Poland

RECRUITING

Investigative Site

Wroclaw, Poland

RECRUITING

Investigative Site

Pretoria, South Africa

RECRUITING

Investigative Site

Stellenbosch, South Africa

RECRUITING

Investigative Site

Badajoz, Spain

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, CutaneousLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Krista Miller

CONTACT

913-410-2156AERIS@iconplc.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Sponsor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2025

First Posted

December 3, 2025

Study Start

December 3, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 11, 2026

Record last verified: 2026-01

Locations

US(10)PL(7)FR(2)GE(1)BU(3)ZA(2)ES(1)HU(1)