The AERIS Study
Study Title:
A Phase 2a Study of Oral VENT-03 In Adults with Cutaneous Lupus Erythematosus, With or Without Systemic Lupus Erythematosus
Sponsor Name:
Ventus Therapeutics
Purpose of Study:
This study is evaluating an investigational oral medication, VENT-03, in adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). There are currently no FDA-approved advanced therapies for cutaneous lupus.
The purpose of the study is to assess whether the investigational medication can safely reduce skin symptoms associated with CLE, including rashes, skin lesions, areas of skin that are red, scaly, or thickened, and changes in skin color or scarring.
What Does This Study Involve?
The study includes people with active CLE whether or not other organs such as the joints are also affected.
Participation in the study lasts up to 18 weeks, and includes:
- Screening: to see if you qualify to participate in the study
- 4-week randomized, double-blind treatment period: Participants are randomly assigned in a 1:1 ratio to receive either VENT-03 or a placebo, which means there is an equal chance of receiving study drug or placebo. This assignment is double-blind, meaning neither the participant nor the study team knows who is receiving VENT-03 versus a placebo during this phase.
- 8-week open-label extension: During this part of the study, all participants receive VENT-03.
- Follow-up visits: To monitor safety and outcomes after treatment concludes.
Participants will receive medical care and be closely monitored throughout the study. They will also receive compensation for their time and efforts. Travel reimbursement may be available as well.
To Consider Participation in This Study, You Must:
- Be between 18 and 80 years old
- Be diagnosed with cutaneous lupus erythematosus (CLE)
- Be experiencing skin symptoms anywhere on the body, with or without facial skin symptoms; If symptoms occur on your face, they must also be present on other areas of the body to be eligible
If you have any of the following, you will not be able to participate:
- Lupus caused by a medication (Drug-induced lupus), rather than lupus that occurs on its own (idiopathic lupus)
- Diagnosis of antiphospholipid antibody syndrome
Additional inclusion/exclusion criteria may apply and will be discussed with you by the study team.
Learn More
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. If you are a person living with lupus and you want to learn more about clinical trials and other research opportunities that may be right for you, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®).
Already part of RAY? To stay connected, reactivate your account today at ray.lupus.org. Sign in with the email linked to your RAY account, update your password, verify your email, and review your profile and consent form.
Need help? We're here at RAYcoordinator@lupus.org.