GLEAM: A Phase 2b Study of IMVT-1402 in Skin Lupus
Study Title:
A Phase 2b Study of IMVT-1402* in Participants with Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (cCLE).
Sponsor Name:
Immunovant Sciences GmbH
Purpose of Study:
The GLEAM study is looking at a new investigational drug, IMVT-1402*, to help people with cutaneous lupus erythematosus (CLE), also known as skin lupus, manage their symptoms, and as a result, gain a better quality of life.
You may be eligible to participate in this study if you:
- Are aged 18 or older
- Have active ‘subacute’ or ‘chronic’ skin lupus (that was not caused by medications)
- Have not been able to control your symptoms while using available treatments for at least 12 weeks or have not tolerated available treatments
- Have no other inflammatory skin conditions
You are not eligible to participate in this study if you:
- Have known or suspected drug-induced CLE, anti-phospholipid disease, or neuropsychiatric SLE.
- Have rapidly progressive kidney-related lupus (lupus nephritis).
There may be additional eligibility requirements / restrictions, which the study team will discuss with you. If you don’t qualify now, you may choose to be contacted later to see if you qualify in the future.
What will happen during the study if you participate?
- The study will last about 61 weeks, including screening, treatment and follow-up phases. During the study, you may continue taking your current medication(s) as long as they are not on the list of medications not allowed by this study. If you choose to remain on your approved current medications, the study team will record them as part of the medical record at certain visits so we can keep track of everything safely.
- In period 1 of the study, you will receive either the investigational drug (IMVT-1402*) or a placebo (an injection with no active medication) - neither you nor the study staff will know which you receive. After completion of period 1, all participants will receive the IMVT-1402 in periods 2 and 3.
The study is being conducted at multiple clinical research sites in the United States.
Neither you nor your insurance will have to pay for study-related care or the medication.
Eligible participants may receive reimbursement for some, or all study related expenses, including travel expenses.
*IMVT-1402 is an investigational drug not approved for use by any regulatory authority in any jurisdiction.
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 or a caregiver and you want to learn more about clinical trials and other research opportunities that may be right for you or your family member living with lupus, sign up for the Lupus Foundation of America’s Research Accelerated by You (RAY®) online patient and caregiver registry, if you have not already done so. Compensation is available.