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

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Brief Title

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

Official Title

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

Brief Summary

      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 control gel. The control gel is an identical looking
      sunflower oil gel that does not contain any active substance. The participant will receive
      either Oleogel-S10 or control 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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of patients with first complete closure of the EB target wound within 45 days of treatment

Secondary Outcome

 Time to first complete closure of the EB target wound as evidenced by clinical assessment until EDBP (D90±7)

Condition

Epidermolysis Bullosa

Intervention

Oleogel-S10

Study Arms / Comparison Groups

 Oleogel-S10
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

223

Start Date

March 29, 2017

Completion Date

July 2022

Primary Completion Date

June 11, 2020

Eligibility Criteria

        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
             enrolment,

          -  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
             carcinomas,

          -  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.
      

Gender

All

Ages

21 Days - N/A

Accepts Healthy Volunteers

No

Contacts

Johannes S Kern, MD PhD, , 

Location Countries

Argentina

Location Countries

Argentina

Administrative Informations


NCT ID

NCT03068780

Organization ID

BEB-13

Secondary IDs

2016-002066-32

Responsible Party

Sponsor

Study Sponsor

Amryt Research Limited


Study Sponsor

Johannes S Kern, MD PhD, Principal Investigator, Melbourne Health


Verification Date

March 2022