Study to Test How Safe and Effective IMVT-1402 is in Adults with Active Subacute Cutaneous Lupus Erythematosus
Researchers are testing a drug called IMVT-1402 to see if it is safe and if it helps people with skin lupus (a type called subacute or chronic cutaneous lupus) with or without lupus that affects the whole body.
Why this Research Matters
This study will help us learn more about how to treat skin lupus. It may help people with skin lupus, with or without lupus that affects the whole body, in the future. The drug being tested is called investigational, which means it hasn’t been approved by the FDA for treating lupus yet.
What to Expect
If you join the study, in the first part, you will be placed into one of two groups. You won’t know which group you’re in, and neither will the study team. One group will get the study drug, IMVT-1402. The other group will get a placebo, which looks the same but has no active medicine. Both the study drug and the placebo will be given using an injection device. Each weekly dose includes two injection devices. You can give yourself the treatment at home, have a friend or family member help, or come to CU Anschutz once a week to get the treatment. In the second part of the study, everyone will get the study drug for 14 weeks. In the third part of the study, you’ll be placed into one of two groups again. One group will get 300 mg of the study drug, and the other group will get 600 mg. You and the study team won’t know which group you’re in. The last part of the study lasts 4 weeks. You won’t get any treatment during this time, but we’ll check your health and ask you questions. As part of the study, we will ask you for some personal information and look at your medical history. At the study visits, you’ll get a physical exam, and we’ll check your temperature, blood pressure, pulse, and breathing. We’ll do a skin biopsy, where a small piece of skin is removed, and take pictures of your skin. You’ll have a heart test called an ECG, which shows your heart rate and rhythm. We’ll also ask for blood and urine samples at different visits. You will fill out surveys at each visit to tell us how you’re feeling.
Study Duration
In the first part of the study, you will have 13 visits, and 6 of them will be in-person. In the second part, you will have 14 visits, with 4 in-person. In the third part, there will be 26 visits and 4 of those will be in-person. At the end of the study, you will have one final in-person visit. The study has four parts. The first part lasts 12 weeks, the second part lasts 14 weeks, the third part lasts 26 weeks, and the last part lasts 4 weeks. You must finish each part before moving on to the next part of the study. The whole study takes about 56 weeks to complete.
Who can Participate
You may be able to join this study if:
- You are 18 years old or older.
- You have a type of skin lupus called subacute or chronic cutaenous lupus, confirmed by a skin test (biopsy).
- You have tried a corticosteroid or antimalarial medicine for at least 12 weeks, but it didn't work, or you had to stop taking it because of side effects
You may not be able to join this study if:
- You have a type of lupus caused by certain medicines, or you have a condition called antiphospholipid syndrome, or have lupus that affects the brain.
- You have serious kidney problems.
- You have another skin condition (not skin lupus) that could make it hard to check your skin during the study.
- You are taking certain immune system medicines that:
- You started less than 3 months ago.
- You havent been on a steady dose for at least 1 month.
- You are taking more than the allowed amount of one of the following medicines: Prednisone over 20mg/day; Hydroxychloroquine over 400 mg/day; Quinacrine over 100mg/day; Chloroquine over 250mg/day; Azathioprine over 200mg/day; Dapsone over 150mg/day; Methotrexate over 25mg/day; 6-mercaptopurine over 1.5mg/kg/day; Mycophenolate mofetil over 3g/day; or Mycophenolate sodium over 2160mg/day.
Study ID
Protocol Number: 24-2239
Compensation Information
Meet the Team
Principal Investigator