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 range
28 Days – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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)
. Use of systemic antibiotics within 7 days before enrollment.