Status:
RECRUITING
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Epidermolysis Bullosa
Junctional Epidermolysis Bullosa
Eligibility:
All Genders
21+ years
Phase:
PHASE3
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 Japa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06917690
Start Date
April 18 2025
End Date
September 1 2029
Last Update
December 22 2025
Active Locations (6)
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1
Fukuoka Children's Hospital - Dermatology
Fukuoka, Japan
2
Kurume University Hospital
Fukuoka, Japan
3
Kobe University Hospital
Kobe, Japan
4
Niigata University Medical and Dental Hospital
Niigata, Japan