Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Recruiting
Phase 3
Interventional Study
Epidermolysis Bullosa (EB)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 28 Days – 12
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Paradigm Therapeutics · Industry
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About This Trial
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 st…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 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.
2. Patient (or caretaker) must be willing to comply …
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