Trials / Recruiting
RecruitingNCT06594393
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients With Epidermolysis Bullosa
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Xinnate AB · Industry
- Sex
- All
- Age
- 4 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 2, double-blind, randomized, vehicle-controlled study designed to evaluate efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed DEB or JEB. The study will implement intrasubject randomization, ie, a pair of matching index wounds will be randomly assigned to be treated with a local application of either TCP 25 gel or vehicle gel.
Detailed description
The study will include a Screening Period, a Treatment Period (Days 1 to 56, with study visits conducted every 2 weeks, including the baseline \[Day 1\], Day 14, Day 28, Day 42, and Day 56 visits) and a Safety Follow-up conducted via a telephone/video call at approximately 14 days after the last dose of the IMP. Patients will undergo efficacy, safety, tolerability, and PK assessments at scheduled visits. For evaluation of the primary efficacy endpoint, a trained clinician will take the images of the index wounds at all scheduled visits from baseline through Day 56 (Visit 6) using 3D digital photography and software for wound measurement.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TCP-25 gel | Topical gel |
| DRUG | Vehicle (placebo) | Placebo gel |
Timeline
- Start date
- 2026-01-30
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
- First posted
- 2024-09-19
- Last updated
- 2026-01-29
Locations
6 sites across 4 countries: France, Greece, Spain, Sweden
Source: ClinicalTrials.gov record NCT06594393. Inclusion in this directory is not an endorsement.