NCT06594393 A Phase 2 Study of TCP-25 Gel in Patients With Epidermolysis Bullosa, STEP-study
| NCT ID | NCT06594393 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Xinnate AB |
| Condition | Epidermolysis Bullosa (EB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 32 participants in total. It began in 2026-01-30 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06594393 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, studying Epidermolysis Bullosa (EB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06594393 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06594393 currently recruiting?
Yes, NCT06594393 is actively recruiting participants. Contact the research team at info@xinnate.com for enrollment information.
Where is the NCT06594393 trial being conducted?
This trial is being conducted at Paris, France, Athens, Greece, Thessaloniki, Greece, Rome, Italy and 5 additional locations.
Who is sponsoring the NCT06594393 clinical trial?
NCT06594393 is sponsored by Xinnate AB. The trial plans to enroll 32 participants.