An Open Label Multi-Center Extension Study to Evaluate the Long-term Safety of Zorblisa<br>(SD-101-6.0) in Patients with Epidermolysis Bullosa<br>
Phase 3
Completed
- Conditions
- Inherited connective tissue disease10014982Genetic skin disorder
- Registration Number
- NL-OMON43935
- Lead Sponsor
- Scioderm Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
1. Informed Consent form signed by the subject or subject's legal representative; if the subject
is under the age of 18 but capable of providing assent, signed assent from the subject.
2. Subject (or caretaker) must be willing to comply with all protocol requirements.
3. Patients who completed the SD-005 study (on study drug at Visit 5).
Exclusion Criteria
1. Patients who do not meet the entry criteria outlined above.
2. Pregnancy or breastfeeding during the study. (A urine pregnancy test will be performed at
the final visit for SD-005 for female patients of childbearing potential)
3. Females of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective is to demonstrate the longterm safety of ZORBLISA in<br /><br>patients, with Simplex, Recessive Dystrophic, and Junctional non-Herlitz<br /><br>Epidermolysis Bullosa.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objectives are to assess the efficacy of ZORBLISA in terms of the<br /><br>change in Body Surface Area (BSA) of lesional skin and wound<br /><br>burden; as well as closure of unhealed target wounds from the SD-005 study.</p><br>