Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06917690

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

Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
6 (estimated)
Sponsor
Chiesi Farmaceutici S.p.A. · Industry
Sex
All
Age
21 Days
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGOleogel-S10Topical gel

Timeline

Start date
2025-04-18
Primary completion
2026-03-01
Completion
2029-09-01
First posted
2025-04-08
Last updated
2025-12-22

Locations

6 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT06917690. Inclusion in this directory is not an endorsement.