A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With … (NCT06917690) | Clinical Trial Compass
RecruitingPhase 3
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
Japan6 participantsStarted 2025-04-18
Plain-language summary
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.
Who can participate
Age range21 Days
SexALL
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Inclusion criteria
✓. 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:
✓. A female subject must meet one of the following criteria:
✓. 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:
✓. 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
Exclusion criteria
✕. Hypersensitivity to Oleogel-S10 or any of its excipients
✕. Diagnosis of EB subtypes simplex or Kindler EB
✕. Receipt of systemic antibiotics for wound-related infections within 7 days prior to enrollment
✕. Receipt of systemic or topical (on EB wounds) steroids within 30 days prior to enrollment Exceptions: Inhaled, ophthalmic, or mucosal applications, such as budesonide suspension for esophageal strictures
✕. Receipt of immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrollment Note: Dupilumab to manage pruritis is allowed if the subject has been on a stable dose for more than 3 months prior to baseline
✕. Receipt of systemic gene therapy for the treatment of inherited EB
✕. Receipt of short-acting stem cell therapy (infusion of Muse cells, allogeneic adipocyte-derived MSC sheet (topically applied), TEMCELL (allogeneic MSCs, subcutaneous injection)) within 6 months prior to study enrollment
✕. Receipt of topical gene therapy for the treatment of inherited EB (e.g., beremagene geperpavec) within 3 months prior to enrollment