Study to Evaluate the Long-term Safety of Zorblisa in Patients with Epidermolysis Bullosa
Research type
Research Study
Full title
An Open Label, Multi-center, Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients with Epidermolysis Bullosa
IRAS ID
174438
Contact name
Anna Martinez
Contact email
Sponsor organisation
Scioderm, INC
Eudract number
2014-005679-96
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
This investigation is being conducted to look into the long-term safety of the study drug, ZORBLISA (SD101-6.0), to treat patients suffering with Epidermolysis Bullosa (EB), for which there is currently no cure. EB is a group of rare inherited diseases characterised by fragile skin that can become damaged by mild friction, causing severe blistering.
The study cream, SD101, is known to help facilitate healing of wounds by affecting the various processes associated with wound healing.
All patients participating in the SD-006 study will receive the SD101 cream. This is an extension to the SD-005 study meaning that all patients that completed the SD-005 study will be offered to participate in SD-006. Those who enrolled into SD-005 but did not complete will not be permitted to take part in the SD-006 study.
Approximately 130 subjects will participate worldwide, with each patient using the cream for a period of 360 days. The study period will consist of screening, treatment, visits to the clinic at 1,3,6 and 9 months and a final visit/early termination visit.
SD-101-6.0 cream will be applied once a day, to the entire body, for a period of 360 days. Patients will come into the study site to have 1 target wound selected at baseline. The safety of SD-101-6.0 will be assessed by monitoring the tolerability, adverse events (AEs), and physical examinations.
For target wounds that are not closed by the end of the SD-005 study, the ARANZ picture and target wound area at the final SD-005 visit will be used as the baseline target wound for SD-006. These unhealed target wounds willbe assessed using the ARANZ SilhouetteStarat each scheduled visit until the target wound is documented as closed.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0385
Date of REC Opinion
10 Mar 2015
REC opinion
Favourable Opinion