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
Xinnate AB
32 participants
Jan 30, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- 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 Criteria6
- 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.
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Interventions
Topical gel
Placebo gel
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06594393