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Tests treatment safety and results for Epidermolysis Bullosa
Official title A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
ClinicalTrials.gov ID: NCT06917690
What this study is testing
What is Oleogel-S10?
Oleogel-S10 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for epidermolysis bullosa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join 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
You likely can't join 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...
- Receipt of immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrollment Note: Dupilumab to manage pruritis is allowed if...
- Receipt of systemic gene therapy for the treatment of inherited EB
See the full eligibility 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
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Fukuoka, Japan
- Kobe, Japan
- Niigata, Japan
- Ōta-ku, Japan
- Sapporo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 days and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fukuoka, Japan; Kobe, Japan; Niigata, Japan; Ōta-ku, Japan; Sapporo, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.