Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa (NCT07482787) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
80 participantsStarted 2026-05-15
Plain-language summary
The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).
Who can participate
Age range28 Days – 12 Years
SexALL
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Inclusion criteria
✓. Informed Consent (ICF) form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient's legal representative will be required.
✓. Patient (or caretaker) must be willing to comply with all protocol requirements.
✓. Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH EB.
✓. Patient must have 1 target wound (size 10 to 50 cm2).
✓. Patients must be between 28 days to 12 years at study entry
✓. Target wound must be present for 21 days or more.
✓. Patients must have wound burden based on BSA of ≥5% at baseline
Exclusion criteria
✕. Patients who do not meet the entry criteria outlined above.
✕. Selected target wound cannot have clinical evidence of local infection.
✕. Use of any investigational drug or approved EB therapy within 30 days before enrollment.
✕. Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
✕. Use of systemic or topical steroidal therapy within 30 days before enrollment. (Inhaled steroids and ophthalmic drops containing steroids are allowed)