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SNCTP000002687 | NCT03068780 | BASEC2017-00764

Doppelblinde, randomisierte, vehikelkontrollierte Wirksamkeits- und Sicherheitsstudie der Phase III mit 24-monatiger offener Nachbeobachtung zu Oleogel-S10 bei Patienten mit erblicher Epidermolysis bullosa

Data source: BASEC (Imported from 28.03.2024), WHO (Imported from 20.03.2024)
Changed: Dec 23, 2023, 4:55 PM
Disease category: Skin and Connective Tissues diseases (non cancer)

Brief description of trial (Data source: BASEC)

Der Zweck dieser klinischen Studie von Oleogel-S10 an Patienten mit erblicher Epidermolysis bullosa besteht darin, zu untersuchen, ob Oleogel-S10 bei Langzeitanwendung wirksam und sicher ist. Dazu erhalten alle Patienten in der Behandlungsphase 3 Monate lang entweder Oleogel-S10 oder ein Gel ohne Wirkstoff. Wenn Sie teilnehmen, wird per Zufall bestimmt, welche Behandlung Sie erhalten, so als wenn man eine Münze werfen würde. Weder Sie noch Ihr Arzt wissen welche Behandlung Sie bekommen. In einer 2-jährigen Nachbeobachtungsphase erhalten Sie dann Oleogel-S10 in jedem Fall. Insgesamt haben Sie im Verlauf dieser Studie 10 planmäßige Besuche und einen (1) flexiblen Besuch. Während der Behandlungsphase haben Sie 7 planmäßige Besuche. In der Nachbeobachtungsphase müssen Sie 3-mal zu einem Besuch in das Krankenhaus kommen.

Health conditions investigated(Data source: BASEC)

Epidermolysis bullosa

Health conditions (Data source: WHO)

Epidermolysis Bullosa

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Anwendung von Oleogel-10 auf sogenannten ‚Zielwunden‘ sowie allen anderen Wunden, die der ‚Zielwunde‘ ähnlich sind.

Interventions (Data source: WHO)

Drug: Oleogel-S10;Drug: Control gel

Criteria for participation in trial (Data source: BASEC)

1. Männliche und weibliche Patienten ab einem Alter von 4 Jahren mit den folgenden Subtypen angeborener EB: Junktionale EB (JEB), Dystrophe EB (DEB) und Kindler Syndrom (KS);
2. Patienten mit einer oberflächliche EB-Wunde von 10 bis 50 cm2 und einem Alter von mindestens 21 Tagen aber nicht mehr als 9 Monaten;
3. Der Patient und/oder der gesetzliche Vertreter ist/sind in der Lage und bereit, die Studienabläufe und -anweisungen einzuhalten.

Exclusion criteria (Data source: BASEC)

1. Patienten mit dem Subtyp EB simplex (EBS);
2. EB-Zielwunde mit Anzeichen einer Infektion auf der Wunde sowie Behandlung von Wundinfektionen mit nicht direkt auf der Wunde angewendeten Antibiotika in den 7 Tagen vor dem Einschluss;
3. Anwendung von Steroiden (ausgenommen zur Inhalation, Anwendung am Auge oder Anwendung auf der Haut, wie beispielsweise eine Budesonid-Suspension bei Speiseröhrenverengung) in den 30 Tagen vor dem Einschluss oder Behandlung mit Medikamenten, die die Immunantwort hemmen oder zytotoxische Chemotherapie in den 60 Tagen vor dem Einschluss.

Inclusion/Exclusion Criteria (Data source: WHO)


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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03068780

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03068780
Further information on trial

Date trial registered

Feb 27, 2017

Incorporation of the first participant

Mar 29, 2017

Recruitment status

Completed

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).

Phase (Data source: WHO)

Phase 3

Primary end point (Data source: WHO)

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

Secundary end point (Data source: WHO)

Time to first complete closure of the EB target wound as evidenced by clinical assessment until EDBP (D90±7);Proportion of patients with first complete closure of the EB target wound at D90±7 based on clinical assessment by the investigator until Day 90±7.;The incidence of wound infection between baseline (DBP D0) and D90±7 as evidenced by AEs and/or use of topical and/or systemic antibiotics (related to wound infection);The maximum severity of wound infection between baseline (DBP D0) and D90±7 as evidenced by AEs and/or use of topical and/or systemic antibiotics (related to wound infection);Change from baseline (DBP D0) in total body wound burden as evidenced by clinical assessment using Section I (assessment of the skin except for the anogenital region) of the 'EB Disease Activity and Scarring Index' (EBDASI) at D90±7;Change from baseline (DBP D0) in itching using the 'Itch Man Scale' in patients = 4 years and up to 13 years of age and the 'Leuven Itch Scale' in patients = 14 years of age before wound dressing changes at D90±7

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Bern

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Croatia, Czechia, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Ukraine, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Dr. Carolina Gouveia
+41 (0)31 632 78 20
Studynurse.Derma@insel.ch

Contact for general information (Data source: WHO)

Johannes S Kern, MD PhD
Melbourne Health

Contact for scientific information (Data source: WHO)

Johannes S Kern, MD PhD
Melbourne Health

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Bern

Date of authorisation by the ethics committee

06.12.2017

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2017-00764

Secondary ID (Data source: WHO)

2016-002066-32
BEB-13
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