Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population. Children and adults may participate. The trial also looks at the safety of Oleogel-S10 gel. The main questions it will answer are: * Does Oleogel-S10 gel close wounds from JEB or DEB within 45 days or reduce the size of the wounds? * Are there any medical problems when using Oleogel-S10 gel? * How much of the drug ends up in your blood? The study has 2 parts. In Part 1, participants will: * Apply Oleogel-S10 gel to the EB wound dressings at least once every 4 days for 45 days. * Visit the clinic once every 2 weeks for checkups and tests. If participants complete Part 1, they may participate in Part 2 if they choose to. In Part 2, participants will continue to receive Oleogel-S10 gel until the product is available to buy in Japan or until the trial is stopped by the company.
• Male or female aged ≥ 21 days
• Confirmed diagnosis of either JEB or DEB
• Both biological parents and all 4 grandparents of Japanese descent
• At least 3 EB wounds that meet the following criteria at the time of enrollment:
‣ All are located outside of the anogenital region
⁃ All are distinguishable from any other wounds on the subject's body (separated by a minimum of 5 cm)
⁃ At least one has been present for a minimum of 21 days but less than 9 months AND is 10 cm2 to 50 cm2 in size
⁃ At least two have been present for a minimum of 21 days but less than 9 months AND/OR are 10 cm2 to 50 cm2 in size
• A female subject must meet one of the following criteria:
‣ If of childbearing potential, she must:
⁃ Have a negative pregnancy test result at Screening and Baseline Visits, AND
• Agree to use one of the following highly reliable methods of contraception from the day of the informed consent signature until the day after the last Oleogel- S10 application. The following methods are acceptable:
∙ Placement of an intrauterine device (IUD) or intrauterine releasing system (IUS)
‣ Combined (both estrogen and progestogen) hormonal contraception (oral) associated with inhibition of ovulation, supplemented with a barrier method (preferably male condom)
‣ Bilateral tubal occlusion
‣ Sexual abstinence, defined as refraining from heterosexual intercourse during the entire study period
‣ Partner vasectomy, provided that the partner is the sole sexual partner and has received medical verification of the surgical success
⁃ Be of non-childbearing potential, defined as one of the following:
• Pre-menarche, OR
∙ Post-menopausal (12 consecutive months of amenorrhea without an alternative medical cause), OR
∙ Permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy (supporting evidence required)
• Subject and/or subject's legal representative has been informed about the study, has read and understood the information provided, and has given written informed consent
• Subject and/or subject's legal representative is able and willing to follow all study procedures and instructions