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    Summary
    EudraCT Number:2020-005271-12
    Sponsor's Protocol Code Number:MetForMe
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-16
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005271-12
    A.3Full title of the trial
    Rediscovery of metformin for the chronic disabling auto-inflammatory disease hidradenitis suppurativa
    Herontdekking van metformine als behandeling voor de chronische huidziekte hidradenitis suppurativa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metformin for the treatment of HS
    Metformine voor de behandeling van HS
    A.3.2Name or abbreviated title of the trial where available
    Metformin in HS
    Metformine voor HS
    A.4.1Sponsor's protocol code numberMetForMe
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorErasmus MC, Department of Dermatology
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC, Department of Dermatology
    B.5.2Functional name of contact pointCoördinating investigator
    B.5.3 Address:
    B.5.3.1Street Addressdr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015CA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310707040110
    B.5.6E-mailk.vanstraalen@erasmusmc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Metformin
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMetformin
    D.3.2Product code RVG 10500
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hidradenitis suppurativa
    Hidradenitis suppurativa
    E.1.1.1Medical condition in easily understood language
    Hidradenitis suppurativa
    Hidradenitis suppurativa
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the clinical efficacy of doxycycline and metformin compared with the standard treatment with doxycycline alone after 24 weeks of treatment.
    Het primaire doel van dit onderzoek is om te klinische effectiviteit van de combinatie van doxycycline en metformine te bepalen ten opzichte van doxycycline monotherapie na 24 weken behandeling.
    E.2.2Secondary objectives of the trial
    - patient reported outcome measures: NRS-pain, flares, QoL (DLQI + EQ-5D-5L), treatment satisfaction and recommendation.
    - clinical effecacy: lesion count, HiSCR, HS-PGA.
    Insulin resistance and metabolic syndrome: HOMA-IR, Hba1c, (waist circumference, blood pressure, HDL cholesterol, and triglycerides).
    - Cost-effectiveness
    - Biomarker: calprotectin
    - Safety and tolerability: incidence and severity of all adverse events
    - patient gerapporteerde uitkomstmaten: NRS-pijn, opvlammingen, kwalitieit van leven (DLQI + EQ-5D-5L), behandeltevredenheid
    - klinische effectiviteit: verandering in aantal lesie's, HiSCR, HS-PGA.
    - insuline resistentie en het metabole syndroom: HOMA-IR, HbA1c, (taille omvang, bloeddruk, HDL cholesterol, en triglyceriden)
    - kosteneffectiviteit
    - biomarker: calprotectine
    veiligheid en verdraagzaamheid: incidentie en ernst van alle adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 years at baseline
    • A diagnosis of HS for at least 1 year prior to baseline
    • mild to moderately active disease defined by a HS Physician Global Assessment (HS-PGA)
    score of 2-3 and the Refined Hurley classification of mild to moderate at baseline
    • Indication for systemic therapy; i.e. uncontrolled disease under conventional topical therapy.
    • Able and willing to give written informed consent and to comply with the study requirements.
    • Leeftijd ≥18 jaar op baseline
    • Een diagnose van HS voor minimaal 1 jaar voor baseline
    • mild tot matige actieve ziekte gedifinieerd als een HS Physician Global Assessment (HS-PGA)
    score van 2-3 en een Refined Hurley classificatie vanmild of matig op baseline
    • Indicatie voor systemische therapie; ongecontroleerde ziekte onder conventionele topicale
    therapie.
    • Bereid om geschrevne informed concent te geven en zich te houden aan de studie regels.
    E.4Principal exclusion criteria
    • Pregnant and lactating women
    • Concomitant diabetes mellitus
    • Use of oral antibiotics within 14 days prior to baseline
    • Use of immunosuppressing/modulating therapies within 28 days prior to baseline
    • A known allergy to metformin or doxycycline or any of the ingredients metformin or doxycycline
    • Zwangere vrouwen of vrouwen die borstvoeding geven
    • Bekend met diabetes mellitus
    • Gebruik van orale antibiotica binnen 14 dagen voor baseline
    • Gebruik van immunomodulerende of immuunsysteem onderdrukkende medicatie binnen 28
    dagen voor baseline
    • Bekende allergie voor metformine of doxyxycline of een van de ingredienten voor metformine
    of doxycycline.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in International Hidradenitis Suppurativa Severity Score System (IHS4) between the groups
    Het primaire eindpunt is het verschil in International Hidradenitis Suppurativa Severity Score System (IHS4) tussen de twee groepen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    week 24
    E.5.2Secondary end point(s)
    Patient reported outcome measures:
    • Change in skin related pain on a numerical rating scale from baseline and differences between the groups at week 12 and 24.
    • Change in self-reported frequency of flares from baseline and differences between the groups at week 12 and 24.
    • Change in quality of life measures with the DLQI and EQ-5D-5L from baseline and differences between the groups at week 12 and 24.
    • Treatment satisfaction and recommendation on a 5- and 3-point Likert scale respectively after 12 and 24 weeks

    Clinical efficacy
    • Change in lesion count from baseline and differences between the groups at week 12 and 24.
    • The percentage of HiSCR achievers after 12 and 24 weeks
    • The percentage of modified HiSCR achievers after 12 and 24 weeks
    • The percentage of patients with a reduction in HS-PGA from baseline and differences between the groups at week 12 and 24. after 12 and 24
    weeks

    Insulin resistance and metabolic syndrome
    • Change in insulin resistance measured with the HOMA-IR from baseline and differences between the groups at week 12 and 24.
    • Change in HbA1c after from baseline and differences between the groups at week 12 and 24.
    • Change in parameters of metabolic syndrome (waist circumference, blood pressure, HDL cholesterol, and triglycerides) from baseline and
    differences between the groups at week 12 and 24.

    Cost-effectiveness
    • Cost-effectiveness of both treatments

    Biomarker:
    • The correlation between baseline calprotectin levels and baseline disease severity.
    • The correlation between calprotectin levels and treatment response at week 12 and 24.

    Safety and tolerability:
    • Incidence and severity of all adverse events throughout the study
    Patient gerapporteerde uitkomstmaten:
    • Verandering in huid gerelateerde pijn ten opzichte van baseline en het verschil tussen de groepen op week 12 en 24.
    • Verandering in zelf-geraporteerde frequentie van opvlammingen ten opzichte van baseline en het verschil tussen de groepen op week 12 en
    24.
    • Verandering inkwaliteit van leven gemten middels de DLQI en EQ-5D-5L ten opzichte van baseline en het verschil tussen de groepen op week
    12 en 24.
    • Behandeltevredenheid en in wekle amte pateinten de behandeling zouden aanraden, respectievelijk op een 5- and 3-punts schaa, na 12 en
    24 weken.

    Klinische effectiviteit
    • Vernadering in aantal leasies ten opzichte van baseline en het verschil tussen de groepen op week 12 en 24.
    • Het percentage HiSCR achievers en het verschil tussen de groepen op week 12 en 24.
    • Het percentage modified HiSCR achievers en het verschil tussen de groepen op week 12 en 24.
    • De verandering in HS-PGA ten opzichte van baseline en het verschil tussen de groepen op week 12 en 24.

    Insulin resistance and metabolic syndrome
    • Verandering in insuline resistentie gemeten met de HOMA-IR ten opzichte van baseline en het verschil tussen de groepen op week 12 en 24.
    • Verandering in HbA1c ten opzichte van baseline en het verschil tussen de groepen op week 12 en 24.
    • Verandering in de parameters of metabool syndroom (taille omvang, bloeddruk, HDL cholesterol, en triglyceriden) ften opzichte van baseline
    en het verschil tussen de groepen op week 12 en 24.

    Kosteneffectiviteit
    • Kosteneffectiviteit van beide behandelingen.

    Biomarker:
    • De correlatie tussen baseline calprotectine levels en baseline ziekte ernst.
    • De correlatie tussen calprotectin levels en behandel effec na 12 en 24 weken.

    Veiligheid en verdraagzaamheid
    • De incidenctie en ernst van alle adverse vents gedurende de studie.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints for patient reported outcomes, clinical effecacy, insulin resistance and metabolic syndrome and biomarker will be 12 and 24 weeks. cost-effectivenes and safety and tolerability will be measured throughout the study and evaluated at 24 weeks.
    De eindkomstmaten voor patient gerapporteerde uitkomstmaten, klinische effectiviteit, insuline resistentie en het metabole syndroom en de biomoarker zullen op 12 en 24 weken worden bekeken. de kosteneffectiviteit en veiligheid en verdraagzaamheid zullen door de studie heen bijgehouden worden en op week 24 geevalueerd.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state62
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    patients will be treated in accordance with general practice
    patienten zullen behandeld worden volgens de huidige standaard zorg
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-22
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