Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa

• Status: Terminated
• Trial end date: 2018-09-03
• Target enrollment: 0
• Participant gender: All

Summary

The study aimed to assess the long-term safety of topical use of Zorblisa (SD-101-6.0) in participants with Epidermolysis Bullosa (EB).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scioderm, Inc.
• Collaborators: Amicus Therapeutics; Amicus Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Informed Consent Form signed by the participant or participant's legal representative; if the participant was under the age of 18 but capable of providing assent, signed assent from the participant.

• Participant (or caretaker) must have been willing to comply with all protocol requirements.

• Participants who completed the SD-005 study (on study drug at Visit 5, approximately 90 days from baseline).

Exclusion Criteria:

• Participants who did not meet the entry criteria outlined above.

• Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at the final visit for Study SD-005 for female participants of childbearing potential and repeated at screening/baseline visit of Study SD-006 if these visits did not occur on the same day).

• Female participants of childbearing potential who were not abstinent or not practicing a medically acceptable method of contraception.