A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa

NCT ID: NCT06917690

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-18
• Study Completion Date: 2029-09-30

Brief 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.

Conditions

Epidermolysis Bullosa; Junctional Epidermolysis Bullosa; Epidermolysis Bullosa, Dystrophic; Epidermolysis Bullosa, Junctional; Skin Abnormalities; Connective Tissue Disease; Collagen Diseases; Skin Diseases; Genetic Diseases, Inborn; Congenital Abnormalities

Keywords

Filsuvez; Birch Bark extract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oleogel-S10

Group Type: EXPERIMENTAL

Oleogel-S10

Intervention Type: DRUG

Topical gel

Interventions

Oleogel-S10

Topical gel

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fukuoka Children's Hospital - Dermatology

Fukuoka, , Japan

Site Status: RECRUITING

Kurume University Hospital

Fukuoka, , Japan

Site Status: RECRUITING

Kobe University Hospital

Kobe, , Japan

Site Status: RECRUITING

Niigata University Medical and Dental Hospital

Niigata, , Japan

Site Status: RECRUITING

Toho University Omori Medical Center

Ōta-ku, , Japan

Site Status: RECRUITING

Hokkaido University Hospital

Sapporo, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Chiesi Clinical Trials

Role: CONTACT

Phone: +3905212791

Email: clinicaltrials_info@chiesi.com

Facility Contacts

Chiesi Clinical Trials

Role: primary

Chiesi Clinical Trials

Role: primary

Chiesi Clinical Trials

Role: primary

Chiesi Clinical Trials

Role: primary

Chiesi Clinical Trials

Role: primary

Chiesi Clinical Trials

Role: primary

Other Identifiers

CLI-FILSVAA2-01

Identifier Type: -

Identifier Source: org_study_id