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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Xinnate AB
Study ID
NCT06594393
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dystrophic Epidermolysis Bullosa
  • Epidermolysis Bullosa (EB)
  • Junctional Epidermolysis Bullosa

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TCP-25 gel — DRUG
    Topical gel
  • Vehicle (placebo) — DRUG
    Placebo gel

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Jan 30, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TCP-25
    Topical gel
  • Placebo Comparator: Vehicle
    Placebo gel

Primary Outcome Measure

Open wound area [ Time Frame: 56 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Dr. Kalyani Marathe, PI, MD
[email protected]

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By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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