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

NCT06594393 | Recruiting Phase 2 DMC

• 1 other identifier: TCP25-002
• Study Type: interventional
• Target: 32
• Locations: 4 countries
• Sites: 6

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.

Conditions

Epidermolysis Bullosa (EB); Dystrophic Epidermolysis Bullosa; Junctional Epidermolysis Bullosa

Keywords

epidermolysis bullosa; topical treatment

Outcome Measures

Primary Outcomes (1)

• Open wound area

  56 days

Secondary Outcomes (8)

• Frequency, intensity, and seriousness of Adverse Events in all treated patients until end of treatment

  56 days

• Change in procedural pain using the Wong Baker FACES® Pain Rating Scale (0 min -10 max)

  56 days

• Change from baseline in clinical impression of overall treatment area

  56 days

• TCP-25 plasma concentrations

  56 days

• Number of participants with treatment-related local tolerability assessment at the area of IMP application assessed on a 4-point scale

  56 days

Study Arms (2)

TCP-25

EXPERIMENTAL

Topical gel

Drug: TCP-25 gel

Vehicle

PLACEBO COMPARATOR

Placebo gel

Drug: Vehicle (placebo)

Interventions

TCP-25 gel DRUG

Topical gel

TCP-25

Vehicle (placebo) DRUG

Placebo gel

Vehicle

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinnate AB: lead

Study Sites (6)

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, 23735, Sweden

NOT YET RECRUITING

Related Publications (1)

• Lundgren S, Wallblom K, Fisher J, Erdmann S, Schmidtchen A, Saleh K. Study protocol for a phase 1, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of ascending topical doses of TCP-25 applied to epidermal suction blister wounds in healthy male and female volunteers. BMJ Open. 2023 Feb 22;13(2):e064866. doi: 10.1136/bmjopen-2022-064866.

  PMID: 36813496 BACKGROUND

MeSH Terms

Conditions

Epidermolysis Bullosa; Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Collagen Diseases; Connective Tissue Diseases

Central Study Contacts

Head of Clinical Development

CONTACT

46462756000; info@xinnate.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intra-subject control

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: January 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

SE (1); ES (2); FR (1); GR (2)