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.
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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 …
Contacts

Kathleen Watts

352-586-4083

Cure@Kapadi.com

CONTACT

Robert P Ryan, PhD

919-274-0703

rryan@paradigmtherapeutics.com

CONTACT