Epidermolysis BullosaPhase 3REVIVENCT06917690
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
A Phase 3 study testing Oleogel-S10 in people with Epidermolysis Bullosa and Junctional Epidermolysis Bullosa, run by Chiesi Farmaceutici S.p.A. at 6 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 days and older
- Conditions the study is for
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic
- What is being tested?
- Oleogel-S10
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 6 sitesJapan
- Study dates
- 18 Apr 2025to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Japan6 sites, 6 recruiting
- Recruiting
Fukuoka Children's Hospital - Dermatology
Fukuoka
Chiesi Clinical Trials, clinicaltrials_info@chiesi.com
- Recruiting
Kurume University Hospital
Fukuoka
Chiesi Clinical Trials, clinicaltrials_info@chiesi.com
- Recruiting
Kobe University Hospital
Kobe
Chiesi Clinical Trials, clinicaltrials_info@chiesi.com
- Recruiting
Niigata University Medical and Dental Hospital
Niigata
Chiesi Clinical Trials, clinicaltrials_info@chiesi.com
- Recruiting
Toho University Omori Medical Center
Ōta-ku
Chiesi Clinical Trials, clinicaltrials_info@chiesi.com
- Recruiting
Hokkaido University Hospital
Sapporo
Chiesi Clinical Trials, clinicaltrials_info@chiesi.com
About this study
Official title: Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)
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?
Read more
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
- Being tested
- Oleogel-S10
- Keywords
- Filsuvez, Birch Bark extract
- Medical subject headings
- Epidermolysis Bullosa, Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica, Skin Abnormalities, Connective Tissue Diseases, Collagen Diseases, Skin Diseases, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oleogel-S10Drug
Topical gel
| Study group | Role | What they receive |
|---|---|---|
| Oleogel-S10 | Experimental | Not described Receives: Drug: Oleogel-S10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of Oleogel-S10 in Part I
The number and percentage of closed wounds within Part I (up to Day 45).
Measured: Enrollment to 45 days
Secondary outcomes (3)
To continue to evaluate the efficacy of Oleogel-S10 up to Day 90 in Part II
Evaluations will include the proportion of participants achieving complete wound closure of at least one target wound, the change in surface area of the wound, patient and clinician impression of improvement, frequency of dressing changes, and incidence of wound infections.
Measured: Enrollment to 90 days
To evaluate the safety and tolerability of Oleogel-S10 in Part I and Part II
Safety will be assessed through monitoring of adverse events, physical examinations, clinical laboratory tests (blood and urine samples), and vital signs from baseline up to study completion.
Measured: Enrollment through study completion, which is estimated for 2029
To evaluate the extent of systemic exposure to betulin
The concentration of betulin in blood at baseline and on Day 45.
Measured: Enrollment to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start18 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidermolysis BullosaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917690
- Sponsor's protocol ID
- CLI-FILSVAA2-01
- Acronym
- REVIVE
- Status last verified
- Dec 2025
- First submitted
- 17 Mar 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)
- ClinicalTrials.gov ID
- NCT06917690
- Acronym / sponsor ID
- REVIVE / CLI-FILSVAA2-01
- Conditions
- Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional, Skin Abnormalities, Connective Tissue Disease
- Keywords
- Filsuvez, Birch Bark extract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oleogel-S10 | Experimental | Drug: Oleogel-S10 |
Who may qualify
- Ages
- 21 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- A female subject must meet one of the following criteria:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oleogel-S10Topical gel | Drug | Oleogel-S10 |
Primary outcome
To evaluate the efficacy of Oleogel-S10 in Part I
Time frame: Enrollment to 45 days
The number and percentage of closed wounds within Part I (up to Day 45).
3 secondary outcomes
To continue to evaluate the efficacy of Oleogel-S10 up to Day 90 in Part II
Time frame: Enrollment to 90 days
To evaluate the safety and tolerability of Oleogel-S10 in Part I and Part II
Time frame: Enrollment through study completion, which is estimated for 2029
To evaluate the extent of systemic exposure to betulin
Time frame: Enrollment to 45 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oleogel-S10 in people with Epidermolysis Bullosa and Junctional Epidermolysis Bullosa, run by Chiesi Farmaceutici S.p.A. at 6 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiesi Clinical Trials (+3905212791, clinicaltrials_info@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of Oleogel-S10 in Part I (time frame: Enrollment to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.