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

NCT ID: NCT07260877

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-03
• Study Completion Date: 2026-09-30

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.

Conditions

Cutaneous Lupus Erythematosus (CLE); Systemic Lupus Erythematosus; SLE; SLE (Systemic Lupus); CLE

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VENT-03

VENT-03

Group Type: EXPERIMENTAL

VENT-03

Intervention Type: DRUG

VENT-03 is a tablet

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is a tablet

Interventions

VENT-03

VENT-03 is a tablet

Intervention Type: DRUG

Placebo

Placebo is a tablet

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ventus Therapeutics U.S., Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigative Site

Beverly Hills, California, United States

Site Status: RECRUITING

Investigative Site

Clearwater, Florida, United States

Site Status: RECRUITING

Investigative Site

DeBary, Florida, United States

Site Status: RECRUITING

Investigative Site

Tampa, Florida, United States

Site Status: RECRUITING

Investigative Site

Saint Joseph, Missouri, United States

Site Status: RECRUITING

Investigative Site

Fairport, New York, United States

Site Status: RECRUITING

Investigative Site

Memphis, Tennessee, United States

Site Status: RECRUITING

Investigative Site

Allen, Texas, United States

Site Status: RECRUITING

Investigative Site

Arlington, Texas, United States

Site Status: RECRUITING

Investigative Site

Colleyville, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Krista Miller

Role: CONTACT

AERIS@iconplc.com

913-410-2156

Other Identifiers

2024-520098-12-00

Identifier Type: CTIS

Identifier Source: secondary_id

VENT-03-201

Identifier Type: -

Identifier Source: org_study_id