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)

Ventus Therapeutics U.S., Inc.

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: VENT-03; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07260877

2024-520098-12-00 (EU Trial (CTIS) Number)

VENT-03-201

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

VENT-03

Experimental group

Description:

VENT-03

Treatment:

Drug: VENT-03

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo