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

Study acronym: STEP
StatusRecruiting
PhasePhase 2
SponsorXinnate AB
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 9 to 10v6
  2. Trial sites expanded: 6 → 9 locationsv5
  3. Study sites: 5 to 6v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 1, 2025 to Jan 30, 2026
    • Enrollment target: 26 to 32
    • Study sites: 1 to 5
    v3
  5. Primary and study completion dates: Jun 30, 2026 to Jun 30, 2027
    • Start date: Mar 31, 2025 to Dec 1, 2025
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06594393
Lead Sponsor Xinnate AB
Conditions
(from sponsor)		 Epidermolysis Bullosa (EB), Dystrophic Epidermolysis Bullosa, Junctional Epidermolysis Bullosa
Related terms Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov