Status:
NOT_YET_RECRUITING
A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
Lead Sponsor:
Xinnate AB
Conditions:
Epidermolysis Bullosa (EB)
Eligibility:
All Genders
4+ years
Phase:
PHASE2
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06594393
Start Date
December 1 2025
End Date
June 30 2027
Last Update
August 28 2025
Active Locations (1)
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1
University hospital
Lund, Skåne County, Sweden, 23735