VENT-03 for Lupus

(AERIS Trial)

Recruiting at 9 trial locations

Overseen By Krista Miller

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ventus Therapeutics U.S., Inc.

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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-3 or a placebo every day 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.

Are You a Good Fit for This Trial?

This trial is for adults with active cutaneous lupus erythematosus (CLE), which may include those with systemic lupus erythematosus (SLE). Participants will be required to take a daily dose of the study drug or placebo and attend monthly clinic visits for checkups and tests.

Inclusion Criteria

I have a severe form of skin lupus with confirmed diagnosis and active lesions.

I have SLE, tested positive for ANA, meet the 2019 criteria, and am on stable SLE medication.

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

Meets protocol specified exclusions related to concomitant medications

Diagnosis of select potentially confounding autoimmune disorders

What Are the Treatments Tested in This Trial?

Interventions

• VENT-03

Trial Overview The trial is testing VENT-03's effectiveness in treating CLE, comparing it against a placebo. Initially, participants receive either VENT-03 or placebo for 4 weeks; afterwards, all switch to VENT-03 for another 8 weeks to further evaluate its efficacy and safety.

How Is the Trial Designed?

Group I: VENT-03 Experimental Treatment 1 Intervention

VENT-03, QD

Group II: Placebo Placebo Group 1 Intervention

Placebo, QD

Who Is Running the Clinical Trial?

Ventus Therapeutics U.S., Inc.

Lead Sponsor

Trials

1

Recruited

30+