Cutaneous Lupus Erythematosus (CLE)Phase 2AERISNCT07260877
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
A Phase 2 study testing VENT-03 in people with Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus, run by Ventus Therapeutics U.S., Inc. at 34 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE
- What is being tested?
- VENT-03
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 3 Dec 2025to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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 locations and contacts
34 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
34 sites in 8 countries
United States15 sites, 15 recruiting
- Recruiting
Investigative Site
Albuquerque, New Mexico, 87102
- Recruiting
Investigative Site
Allen, Texas, 75013
- Recruiting
Investigative Site
Arlington, Texas, 76012
- Recruiting
Investigative Site
Beverly Hills, California, 90211
- Recruiting
Investigative Site
Clearwater, Florida, 33765
- Recruiting
Investigative Site
Colleyville, Texas, 76034
- Recruiting
Investigative Site
DeBary, Florida, 32713
- Recruiting
Investigative Site
Fairport, New York, 14450
- Recruiting
Investigative Site
Flint, Michigan, 48439
- Recruiting
Investigative Site
Indianapolis, Indiana, 46250
- Recruiting
Investigative Site
Memphis, Tennessee, 38119
- Recruiting
Investigative Site
Miami, Florida, 33133
- Recruiting
Investigative Site
Saint Joseph, Missouri, 64506
- Recruiting
Investigative Site
Tampa, Florida, 33606
- Recruiting
Investigative Site
Troy, Michigan, 48084
Poland7 sites, 7 recruiting
- Recruiting
Investigative Site
Bialystok
- Recruiting
Investigative Site
Oświęcim
- Recruiting
Investigative Site
Poznan
- Recruiting
Investigative Site
Rzeszów
- Recruiting
Investigative Site
Śląskie
- Recruiting
Investigative Site
Warsaw
- Recruiting
Investigative Site
Wroclaw
Bulgaria3 sites, 3 recruiting
- Recruiting
Investigative Site
Haskovo
- Recruiting
Investigative Site
Plovdiv
- Recruiting
Investigative Site
Sofia
South Africa3 sites, 3 recruiting
- Recruiting
Investigative Site
Durban
- Recruiting
Investigative Site
Pretoria
- Recruiting
Investigative Site
Somerset West
France2 sites, 2 recruiting
- Recruiting
Investigative Site
Paris
- Recruiting
Investigative Site
Toulouse
Spain2 sites, 2 recruiting
- Recruiting
Investigative Site
Badajoz
- Recruiting
Investigative Site
Madrid
About this study
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?
Read more
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.
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus), CLE
- Being tested
- VENT-03, Placebo
- Keywords
- CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03, cGAS
- Medical subject headings
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENT-03Drug
VENT-03 is a tablet
PlaceboDrug
Placebo is a tablet
| Study group | Role | What they receive |
|---|---|---|
| VENT-03 | Experimental | VENT-03 Receives: Drug: VENT-03 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to End of Double-Blind Treatment (up to Day 28)
Secondary outcomes (8)
Evaluate the effect of VENT-03 on CLE disease severity
Percent change from baseline in CLASI-A score at Day 28
Measured: Baseline to End of Double-Blind Treatment (up to Day 28)
Evaluate effect of VENT-03 on CLE disease severity
Percentage of participants achieving CLASI-A 50 response (≥ 50% improvement in CLASI A score compared with baseline) at Day 28
Measured: Baseline to End of Double-Blind Treatment (up to Day 28)
Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy
Measured: 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)
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.
Measured: Baseline to End of Treatment (up to Day 84)
Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline to End of Treatment (up to Day 84)
Percentage of Participants with ≥ 1 Treatment Emergent Adverse Event (AE) leading to Treatment Discontinuation
Measured: Baseline to End of Treatment (up to Day 84)
Cmax: Maximum Observed Plasma Concentration for VENT-03
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start3 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Lupus Erythematosus (CLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventus Therapeutics U.S., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260877
- Sponsor's protocol ID
- VENT-03-201
- Other IDs
- 2024-520098-12-00
- Acronym
- AERIS
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07260877
- Acronym / sponsor ID
- AERIS / VENT-03-201
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus), CLE
- Keywords
- CLE, SLE, lupus, cutaneous lupus erythematosus, systemic lupus erythematosus, VENT-03, cGAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ventus Therapeutics U.S., Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VENT-03 | Experimental | Drug: VENT-03VENT-03 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cutaneous lupus:
- If participant has previous SLE diagnosis:
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VENT-03VENT-03 is a tablet | Drug | VENT-03 |
| PlaceboPlacebo is a tablet | Drug | Placebo |
Primary outcome
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
8 secondary outcomes
Evaluate the effect of VENT-03 on CLE disease severity
Time frame: 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)
Change from Baseline in Myxovirus-Resistant Protein A (MXA) Immunostaining in Skin Biopsy
Time frame: 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)
Number of participants with Moderate or Severe Treatment Emergent Adverse Events (TEAEs)
Time frame: 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)
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Cutaneous Lupus Erythematosus (CLE)
Active, not recruitingPhase 2/3
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Not yet recruitingPhase 2/3
Phase 2/3 Double-Blind, Placebo-Controlled Study of Afimetoran in Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Active, not recruitingPhase 2
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Systemic Lupus Erythematosus
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VENT-03 in people with Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus, run by Ventus Therapeutics U.S., Inc. at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Poland, Bulgaria, South Africa, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact VENT-03-201 Clinical Services (857-702-2273, medinfo@ventustx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.