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
EU CTIS ID: 2024-515172-12-00
What this study is testing
Evaluate efficacy of TCP-25 gel in promoting wound healing and improving EB symptoms in patients with DEB or JEB Safety Objective: Evaluate safety and tolerability, including local tolerability of TCP-25 gel in patients with DEB or JEB
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping. • Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use. • The patient has the presence of a well-matched index wound pair which will be included in two respective treatment areas, with a minimum distance of at least 5 cm (2 inches) between the treatment areas.
You likely can't join if
- • The patient has any subtype of EB other than DEB or JEB. • The patient is currently being treated or planned to be treated with systemic antibiotics. Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited. • Use of systemic corticosteroids >0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit. Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted. • The patient has a history of any of the following treatments: a. Local topical Filsuvez on the study treatment areas within 1 month before the Screening Visit, b. Local topical gene therapy with Vyjuvek on the study treatment areas within 3 months before the Screening Visit, c. Systemic mesenchymal stem cell treatment, including Ebesenar, within 6 months before the Screening Visit, or d. Cell-gene (graft) therapy, Zevaskyn, for the treatment of EB affecting the treatment areas any time before the Screening Visit. • The patient has a history of or current malignancy over any study treatment area, eg, basal cell carcinoma or squamous cell carcinoma.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.