Topical TCP-25 gel to help heal wounds in epidermolysis bullosa

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

This trial tests whether applying TCP-25 gel to matched skin wounds helps improve healing in children and adults with dystrophic or junctional epidermolysis bullosa.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 4 Years and up
• Sex: All
• Sponsor: Xinnate AB (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 6 sites (Paris and 5 other locations)
• Trial ID: NCT06594393 on ClinicalTrials.gov

What this trial studies

This Phase 2, double-blind, randomized, vehicle-controlled study uses intrasubject randomization where paired index wounds on the same patient are randomized to receive TCP-25 gel or matching vehicle. Treatment is applied over a 56-day period with clinic visits at baseline and every two weeks through Day 56, and a safety follow-up conducted by telephone or video about two weeks after the last dose. Wound healing is measured by trained clinicians using 3D digital photography and specialized software for wound area quantification, alongside safety, tolerability, and pharmacokinetic assessments. The trial initially enrolls patients 12 years and older with genetically or biopsy-confirmed dystrophic or junctional EB, with enrollment of 4–11 year olds planned after a safety review.

Who should consider this trial

Good fit: Ideal candidates are patients aged ≥12 years (initially) with genetically or biopsy-confirmed dystrophic or junctional EB who have at least one pair of comparable wounds and are not receiving systemic antibiotics.

Not a fit: Patients with other EB subtypes, those currently treated with systemic antibiotics, or those who used topical antibiotics on the index wounds within seven days before baseline may not benefit or be eligible.

Why it matters

Potential benefit: If successful, TCP-25 gel could speed wound closure and reduce infection and pain for patients with DEB or JEB.

How similar studies have performed: Topical peptide and antimicrobial wound therapies for EB are limited and this specific TCP-25 gel approach is relatively novel with only limited prior controlled data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 or current malignancy over the index wound, eg, basal cell carcinoma or squamous cell carcinoma.

Where this trial is running

Paris and 5 other locations

• Hopital St Louis — Paris, France (Recruiting)
• Andreas Syngros Hospital of Veneral & Dermatological Diseases — Athens, Greece (Recruiting)
• Hospital Of Skin And Venereal Diseases of Thessaloniki — Thessaloniki, Greece (Recruiting)
• Hospital Clinic de Barcelona — Barcelona, Spain (Recruiting)
• Hospital Univ La Paz — Madrid, Spain (Recruiting)
• University hospital — Lund, Skåne County, Sweden (Not_yet_recruiting)

Study contacts

• Study coordinator: Head of Clinical Development

Conditions Epidermolysis Bullosa; Dystrophic Epidermolysis Bullosa; Junctional Epidermolysis Bullosa; epidermolysis bullosa; topical treatment