RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether VENT-03 helps adults with active skin lupus, with or without lupus that affects other parts of the body. It also checks side effects and how the body handles the drug. Participants take VENT-03 or a placebo (a look-alike with no drug) for 4 weeks, then everyone takes VENT-03 for 8 more weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a skin lupus activity score (CLASI-A) of 8 or higher.
  • Have at least one active skin patch from discoid lupus or subacute skin lupus.
  • If already diagnosed with systemic lupus, have a positive ANA blood test at screening, with a level of at least 1:80.
  • If already diagnosed with systemic lupus, meet the study's 2019 lupus diagnosis rules.
  • If already diagnosed with systemic lupus, take at least one lupus medicine allowed by the study at a steady dose.

Who can't join

  • Have infections, infection history, or lab results that meet the study's exclusion rules or make joining unsafe.
  • Have moderate or severe liver problems, or lupus caused by a drug.
  • Have another past or current joint or skin disease that causes swelling, or certain other diseases where the immune system attacks the body.
  • Have severe active or unstable lupus affecting the brain or mental health.
  • Were hospitalized for a severe lupus flare in the past 3 months, or have severe active lupus, including kidney lupus, that the study's usual care would not treat well enough.
  • Have or have had antiphospholipid syndrome, a condition that can cause blood clots.
  • Needed steroid pills or injections for a disease other than lupus for more than 2 weeks total in the 24 weeks before starting, or take medicines the study does not allow.
  • Have cancer screening results that suggest cancer, or a cancer history within the study's time limits. Exceptions may apply to successfully treated squamous or basal cell skin cancer and very early cervical cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (15)

CA

FL

IN

MI

MO

NM

NY

TN

TX