Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study with 24-month Open-label Follow up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa - EASE study

Amryt Research Limited0 sites250 target enrollmentMarch 8, 2017

Overview

No summary available.

Registry

who.int

Start Date

March 8, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Amryt Research Limited

•A patient will be eligible for study participation only if all of the following criteria apply:
•1\. Male and female patients aged \=4 years with the following subtypes of inherited EB: JEB, DEB, and Kindler syndrome \[Note: Children \=21 days old and \<4 years may be included only after confirmation by the Independent Data Monitoring Committee (IDMC) upon review of the safety and bioanalytical data at the interim safety review stage]
•2\. Patients with an EB target wound (i.e., EB partial thickness wound of 10 cm2 to 50 cm2 in size aged \=21 days and \<9 months) outside of the anogenital region
•3\. Patient and/or his/her legal representative has/have been informed, has/have read and understood the patient information/informed consent form, and has/have given written informed consent
•4\. Patient and/or his/her legal representative must be able and willing to follow study procedures and instructions
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 171
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 72
•F.1\.3 Elderly (\>\=65 years) yes

•A patient will not be eligible to participate in this study if any of the
•following criteria apply:
•1\. Patient has EB subtype EBS
•2\. EB target wound that is \> 9 months old or has clinical signs of local infection
•3\. Use of systemic antibiotics for wound\-related infections within 7 days prior to enrolment
•4\. Administration of systemic or topical steroids (except for inhaled, ophthalmic or topical applications, such as budesonide suspension for oesophageal strictures \[e.g., Pulmicort Respules® 0\.25 mg/2 mL or 0\.5 mg/2 mL]) within 30 days before enrolment
•5\. Immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrolment
•6\. Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB
•7\. Current and/or former malignancy including basal cell carcinomas and squamous cell carcinomas
•8\. Enrolment in any interventional study or treated with any investigational drug for any disease within 4 weeks prior to study entry