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

NCT06917690 | Recruiting Phase 3

• 1 other identifier: CLI-FILSVAA2-01
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

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

Keywords

Filsuvez; Birch Bark extract

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of Oleogel-S10 in Part I

  The number and percentage of closed wounds within Part I (up to Day 45).

  Enrollment to 45 days

Secondary Outcomes (3)

• To continue to evaluate the efficacy of Oleogel-S10 up to Day 90 in Part II

  Enrollment to 90 days

• To evaluate the safety and tolerability of Oleogel-S10 in Part I and Part II

  Enrollment through study completion, which is estimated for 2029

• To evaluate the extent of systemic exposure to betulin

  Enrollment to 45 days

Study Arms (1)

Oleogel-S10

EXPERIMENTAL

Drug: Oleogel-S10

Interventions

Oleogel-S10 DRUG

Topical gel

Oleogel-S10

Eligibility Criteria

• Age: 21 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (6)

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

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous

Central Study Contacts

Chiesi Clinical Trials

CONTACT

+3905212791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 8, 2025
• Study Start: April 18, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (6)