Oleogel-S10 gel for healing skin wounds in Japanese patients with epidermolysis bullosa.

Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)

We will try Oleogel‑S10 gel to see if it closes or shrinks wounds in Japanese children and adults with junctional or dystrophic epidermolysis bullosa.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 21 Days and up
• Sex: All
• Sponsor: Chiesi Farmaceutici S.p.A. (Industry-sponsored)
• Drugs / interventions: Dupilumab, chemotherapy
• Locations: 6 sites (Fukuoka and 5 other locations)
• Trial ID: NCT06917690 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial asks enrolled Japanese patients to apply Oleogel‑S10 to qualifying EB wounds at least once every four days for a 45‑day treatment period, with clinic visits about every two weeks for checks and tests. The study measures wound closure within 45 days, change in wound size, safety events, and how much drug appears in the blood (pharmacokinetics). After completing Part 1, participants may opt into Part 2 to continue receiving the gel until it becomes commercially available in Japan or the study ends. Enrollment requires genetically confirmed junctional or dystrophic EB, specific wound size/duration criteria, and strict Japanese ancestry requirements.

Who should consider this trial

Good fit: Japanese individuals (age ≥21 days) with genetically confirmed junctional or dystrophic EB who have at least three qualifying wounds—including at least one 10–50 cm² wound present 21 days to 9 months—are the intended participants.

Not a fit: People without JEB or DEB, those whose wounds do not meet the size/duration or location criteria, or those who do not meet the strict Japanese ancestry or other eligibility rules are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, Oleogel‑S10 could speed wound closure and reduce wound size, potentially lowering pain and infection risk for people with JEB or DEB.

How similar studies have performed: Earlier trials of Oleogel‑S10 (Filsuvez), a birch‑bark extract, have shown encouraging wound‑healing and safety signals in non‑Japanese EB and other wound settings, though use in Japanese patients is being specifically tested here.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged ≥ 21 days
2. Confirmed diagnosis of either JEB or DEB
3. Both biological parents and all 4 grandparents of Japanese descent
4. 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
5. A female subject must meet one of the following criteria:

   * If of childbearing potential, she must:

     1. Have a negative pregnancy test result at Screening and Baseline Visits, AND
     2. 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)
6. 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
7. Subject and/or subject's legal representative is able and willing to follow all study procedures and instructions

Exclusion Criteria:

1. Hypersensitivity to Oleogel-S10 or any of its excipients
2. Diagnosis of EB subtypes simplex or Kindler EB
3. Receipt of systemic antibiotics for wound-related infections within 7 days prior to enrollment
4. 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
5. 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
6. Receipt of systemic gene therapy for the treatment of inherited EB
7. 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
8. Receipt of topical gene therapy for the treatment of inherited EB (e.g., beremagene geperpavec) within 3 months prior to enrollment
9. Receipt of a JACE® skin graft on any of the target wounds
10. Current and/or former malignancy, including skin malignancies such as basal cell carcinoma and squamous cell carcinoma
11. Females: Pregnant or lactating, or of childbearing potential with a fertile male partner and unwilling to use a highly reliable method of contraception from the informed consent signature until study participation ends
12. Enrollment in any other interventional study or treated with any other investigational drug for any disease within 4 weeks prior to enrollment
13. Presence of any factor in the subject and/or legal representative that could interfere with study compliance, such as the ability to attend the scheduled study visits or to properly manage the dressing changes at home

Where this trial is running

Fukuoka and 5 other locations

• Fukuoka Children's Hospital - Dermatology — Fukuoka, Japan (Recruiting)
• Kurume University Hospital — Fukuoka, Japan (Recruiting)
• Kobe University Hospital — Kobe, Japan (Recruiting)
• Niigata University Medical and Dental Hospital — Niigata, Japan (Recruiting)
• Toho University Omori Medical Center — Ōta-ku, Japan (Recruiting)
• Hokkaido University Hospital — Sapporo, Japan (Recruiting)

Study contacts

• Study coordinator: Chiesi Clinical Trials

Conditions Epidermolysis Bullosa; Junctional Epidermolysis Bullosa; Epidermolysis Bullosa, Dystrophic; Epidermolysis Bullosa, Junctional; Skin Abnormalities; Connective Tissue Disease; Collagen Diseases; Skin Diseases