IMVT-1402-2701 - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called IMVT-1402 (the study drug) can help control cutaneous lupus erythematosus (CLE). We want to know how well the study drug works in comparison to a placebo (inactive substance that has no drug in it).
Cutaneous Lupus Erythematosus (CLE)
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with sub-acute or chronic CLE that is confirmed by biopsy (can be done at screening, if necessary)
- Have a total CLASI-A score of ≥ 10 at screening and beginning of Period 1
- Are positive for at least one of the following at screening: ANA, elevated anti-double-stranded DNA, anti-Ro/SSA, anti-La/SSB, anti-Sm, anti-RNP, or IgG deposition in a skin biopsy
For more information, contact the study team at erin.campo@duke.edu.
What is Involved?
If you choose to join this study, you will take part for up to 61 weeks.
This study is broken down into 5 periods:
- Screening period
- Period 1
- Period 2
- Period 3
- Safety follow-up
During your time in the study, you will have the following tests and procedures at some or all of your visits:
- Vital signs
- Exámenes físicos
- Extracción de sangre
- Urine tests
- Electrocardiograms
- Skin biopsy
In Periods 1, 2, and 3, you will get a dose of the study drug weekly under the skin using an injection device. Each weekly dose will require 2 injections. The injections will be given in the abdomen, upper arm, or thigh with one injection given on the right side of the body, and the second into the corresponding body part on the left.
Period 1 is placebo-controlled, which means you will get a random assignment (like a coin flip) to receive either a 600 mg study drug or placebo injection once weekly for 12 weeks.
Period 2 is open-label. This means that all participants will get a 600mg dose of the study drug weekly for 14 weeks.
During period 3, you will get a random assignment (like a coin flip) to receive either a 300 mg or 600 mg of the study drug once weekly for 26 weeks.
During the safety follow-up, you will have one final clinic visit about 4 weeks after the last injection of the study drug in period 3.
Study Details
