A Phase 2 Study of TCP-25 Gel in Patients with Epidermolysis Bullosa, STEP-study

Launched by XINNATE AB · Sep 10, 2024

Keywords

ClinConnect Summary

This clinical trial, called the STEP-study, is investigating a new treatment called TCP-25 gel for patients with a rare skin condition known as Epidermolysis Bullosa (EB), specifically two types called Dystrophic EB (DEB) and Junctional EB (JEB). The goal is to see how well this gel works, how safe it is, and how well patients tolerate it. During the study, participants will have pairs of wounds on their skin, and one will be treated with the TCP-25 gel while the other will receive a placebo gel (which looks the same but has no active ingredients).

To be eligible for this study, patients must be at least 4 years old and have a confirmed diagnosis of DEB or JEB through genetic testing or a skin biopsy. However, initially, only those aged 12 and older will be enrolled until the safety of the gel is confirmed in younger patients. People with other types of EB or those currently taking certain medications, like systemic antibiotics or high doses of corticosteroids, will not be able to participate. It's important to note that this trial is not yet recruiting participants, so there will be more information available soon about how to join if you meet the eligibility criteria.

Gender

ALL

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.