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

Study Identifier:

CLI-FILSVAA2-01

ClinicalTrials.gov Identifier:

NCT06917690

EudraCT Identifier:

N/A

EU CT ID:

N/A

Study Contact Information:

+3905212791 or [email protected]

Recruiting

Study Details

Medical Condition

Epidermolysis Bullosa
Unmapped

Study Drug

Drug: Oleogel-S10

Date

Apr 2025 - Mar 2026

Phase 1

Phase 2

Phase 3

Phase 4

N/A

Patient Requirements

Sex: Female & Male

Age: 21+ days

Requirements Information

Inclusion and Exclusion Criteria

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:
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

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
Receipt of a JACE® skin graft on any of the target wounds
Current and/or former malignancy, including skin malignancies such as basal cell carcinoma and squamous cell carcinoma
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
Enrollment in any other interventional study or treated with any other investigational drug for any disease within 4 weeks prior to enrollment
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

Healthy Volunteers

Protocol 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.

Study Locations

Location

Status

Location

Fukuoka Children's Hospital - Dermatology

Fukuoka, Japan