Frequently Asked Questions

You should consider applying for this CLE study if you:

• Are 18 years of age or older
• Have a physician-confirmed diagnosis of CLE
• Have not experienced efficacy/success with CLE treatments or interventions in the past
• Have not been diagnosed with any additional inflammatory skin disease (other than CLE), nor drug-induced CLE, nephritis, antiphospholipid disease, or neuropsychiatric SLE
• Are not currently taking immunosuppressive or disease-modifying treatments within the last three months, or if so, patient has been on a stable dose for at least one month

Although it is not guaranteed that your Skin Lupus will benefit from receiving study treatment IMVT-1402 — in fact it may get better, get worse, or stay the same — those who qualify and choose to participate would be making an important contribution to medical research. Clinical studies are the only way to investigate potential new treatments. By participating, you may help improve the lives of others affected by Skin Lupus. Additionally, those enrolled would receive attentive care from dedicated healthcare professionals throughout their participation in the gleam study.

No. If you choose to be in this study, study treatment will be provided to you at no cost. There will be no charge to you for any tests, examinations, and visits done as part of this study. As a participant, you may also be provided with reimbursements for study-related expenses or have travel arrangements provided for you.

As all drugs and medical procedures carry a risk of side effects, the possibility that participants may experience side effects, discomfort, or adverse reactions does exist. The full nature of these risks is unknown, as the investigational treatment has been given to relatively few people. A full explanation of risks will be provided in your Informed Consent Form (ICF) should you meet eligibility requirements, and the study doctor will discuss these with you prior to enrollment.

During this CLE clinical trial, the research team will be studying the ability of the study drug, IMVT-1402, to help treat the symptoms of cutaneous lupus erythematosus (CLE), which is an autoimmune disease. Normally, antibodies identify foreign substances in the body, such as bacteria or viruses, so they can be removed. People with autoimmune diseases produce harmful ‘autoantibodies’ which are antibodies that attack the person’s own cells by mistake. Research indicates that in people with Skin Lupus, these harmful autoantibodies may attack healthy skin cells and cause the chronic inflammation seen in the skin. The study treatment (IMVT-1402) reduces levels of certain antibodies in the blood, including the harmful autoantibodies which are thought to cause Skin Lupus. It is hoped that this may alleviate symptoms in people with Skin Lupus.

Participation in this study is voluntary. This means that you can take back your consent and stop participating in the study at any time and for any reason. It is important for you to tell your study doctor immediately if you decide to stop participating. The study doctor will help you stop your participation safely.

The gleam study is a randomized, double-blind study, meaning neither participants nor study staff will know who receives the investigational treatment, IMVT-1402, vs. placebo, which contains no active medication. The research team will be assessing the efficacy, safety and tolerability of IMVT-1402 in participants with active or chronic CLE, with or without systemic involvement. Participants who qualify and choose to join this study will be enrolled for approximately 61 weeks (or 63 weeks, if the screening period needs to be extended). This clinical research study includes 3 parts: Screening, Treatment, and Follow-Up. There will be a 12-week period in which participants will receive either the investigational treatment or a placebo, both of which can be administered at-home by self-injection to reduce weekly clinic visits. The rest of the active treatment period (40-weeks, not including screening and follow-up), all participants will receive the investigational treatment IMVT-1402. The last period of the study is the Follow-up (FU) period, which lasts for approximately 4 weeks, where participants receive no injections and instead, certain tests or procedures may be performed to monitor patients’ health.

The probability that a participant will receive the placebo during the initial 12-week treatment period is 50%. However, upon completion of that 12-week phase, all participants in this clinical study will go on to receive the study drug, IMVT-1402, for the remainder of the treatment phase, which continues for another 40 weeks.