Phase III Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa

Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Age Range:Any
Start Date:March 29, 2017
End Date:February 2022
Contact:Head of Clinical Development

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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

This is a Phase III, Efficacy and Safety Study of Oleogel-S10 in Participants with Inherited
Epidermolysis Bullosa (EB).

EB is a rare group of genetic skin fragility disorders characterised by blistering of the
skin in response to minor injury. In most cases, onset of EB is at birth or shortly after.
All participants affected by any type of EB share the main characteristic of repeatedly
developing painful wounds that take days to months to heal. Current treatment of EB is
primarily preventative and supportive including protection from mechanical forces by avoiding
rubbing, early treatment of wounds to prevent infections, and protection of the wound with
adequate non-adhesive dressings to enable healing.

Oleogel-S10 was authorised in 2016 in the European Union for treatment of partial thickness
wounds in adults under the brand name Episalvan®. The active pharmaceutical ingredient in
Oleogel-S10 is a refined birch bark extract, quantified to 72 to 88% betulin.

This clinical study of Oleogel-S10 in patients with inherited EB has been initiated to
investigate whether Oleogel-S10 is effective for treatment of EB wounds and safe in the long
term use.

Oleogel-S10 will be compared to a vehicle gel placebo. The placebo is an identical looking
sunflower oil gel that does not contain any active substance. The participant will receive
either Oleogel-S10 or vehicle gel for a double-blind study phase of 90 days. The probability
that the participant will receive Oleogel-S10 is 50%, which means that they have a 1 in 2
chance of receiving Oleogel-S10. However, in the follow-up phase of the study all
participants will be treated with Oleogel S10 for a period of 24 months.

This clinical study will be performed in several countries; in total, about 250 participants
are expected to participate.

Inclusion Criteria:

- Male and female patients with the following subtypes of inherited EB: junctional EB
(JEB), dystrophic EB (DEB), and Kindler syndrome aged ≥21 days,

- 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),

- 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,

- Patient and/or his/her legal representative must be able and willing to follow study
procedures and instructions.

Exclusion Criteria:

- Patient has EB simplex

- EB target wound with clinical signs of local infection,

- Use of systemic antibiotics for wound-related infections within 7 days prior to

- 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,

- Immunosuppressive therapy or cytotoxic chemotherapy within 60 days prior to enrolment,

- Patient has undergone stem cell transplant or gene therapy for the treatment of
inherited EB,

- Current and/or former malignancy including basal cell carcinomas and squamous cell

- Enrolment in any interventional study or treated with any investigational drug for any
disease within 4 weeks prior to study entry,

- Factors present in the patient and/or his/her legal representative that could
interfere with study compliance such as inability to attend scheduled study visits or
compliance with home dressing changes,

- Pregnant or nursing women and women of childbearing potential including postmenarchal
female adolescents not willing to use an effective form of birth control with failure
rates <1% per year (e.g., implant, injectable, combined oral contraceptive,
intrauterine contraceptive device, sexual abstinence, vasectomised partner) during
participation in the study (and at least 3 months thereafter),

- Patient is a member of the investigational team or his/her immediate family,

- Patient lives in the same household as a study participant.
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