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    Summary
    EudraCT Number:2021-001826-23
    Sponsor's Protocol Code Number:MMP-Clob1
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-001826-23
    A.3Full title of the trial
    A prospective, non controlled, phase 2 pilot study to assess the safety and efficacy of a new topical formulation of clobetasol 0.05% for mucosal use in patients with mucous membrane pemphigoid
    Studio pilota di fase II, prospettico, non controllato, per valutare sicurezza ed efficacia di una nuova formulazione topica per uso mucoso a base di clobetasolo 0.05% in pazienti con pemfigoide delle mucose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to assess the safety and efficacy of a new topical formulation of clobetasol 0.05% for mucosal use in patients with mucous membrane pemphigoid
    Studio clinico per valutare sicurezza ed efficacia di una nuova formulazione topica per uso mucoso a base di clobetasolo 0.05% in pazienti con pemfigoide delle mucose
    A.3.2Name or abbreviated title of the trial where available
    Topical clobetasol for patients with mucous membrane pemphigoid
    Studio su clobetasolo topico in pazienti con pemfigoide delle mucose
    A.4.1Sponsor's protocol code numberMMP-Clob1
    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 SponsorDipartimento di Scienze della Salute dell'Università degli Studi di Firenze
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEmiliano Antiga
    B.5.2Functional name of contact pointDSS UniFi
    B.5.3 Address:
    B.5.3.1Street AddressViale Pieraccini 6
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50139
    B.5.3.4CountryItaly
    B.5.6E-mailemiliano.antiga@unifi.it
    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 No
    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 nameclobetasolo propionato
    D.3.2Product code [clobetasolo propionato]
    D.3.4Pharmaceutical form Oromucosal gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 25122-46-7
    D.3.9.2Current sponsor codeclobetasolo propionato
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mucous membrane pemphigoid
    Pemfigoide delle mucose
    E.1.1.1Medical condition in easily understood language
    Mucous membrane pemphigoid
    Pemfigoide delle mucose
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.0
    E.1.2Level LLT
    E.1.2Classification code 10004296
    E.1.2Term Benign mucous membrane pemphigoid without mention of ocular involvement
    E.1.2System Organ Class 100000004858
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 25.0
    E.1.2Level LLT
    E.1.2Classification code 10004294
    E.1.2Term Benign mucous membrane pemphigoid
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the safety of a 0.05% clobetasol topical formulation (number, entity, severity and nature of possible side effects)
    Valutazione della sicurezza della formulazione per uso oromucosale a base di clobetasolo 0.05% (numero ed entità, serietà e natura di eventuali effetti avversi)
    E.2.2Secondary objectives of the trial
    Evaluation of tolerability (patients compliance, number of patients who complete the course of therapy) and response to treatment (reduction of clinical objective and subjective score of disease activity)
    Valutazione della tollerabilità (compliance dei pazienti, numero di pazienti che completano il ciclo terapeutico) e della risposta al trattamento (riduzione di score clinici soggettivi ed oggettivi relativi alla gravità di malattia)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female from 18 to 90 years old
    - Clinical and immunopathological diagnosis of mucous membrane pemphigoid with active lesions on oral mucosa
    - Dental hygiene treatment before the beginning of the study
    - Stable disease activity: stable immunosuppressive therapy in the last 8 weeks and/or stable systemic steroids therapy (prednisone or comparable steroid) 10 mg/die or lower
    - Ability to comprehend all the clinical criteria, to give informed consent and to perform all the clinical procedure
    - Pazienti di entrambi i sessi di età compresa tra i 18 e i 90 anni
    - Diagnosi clinica e immunopatologia di pemfigoide delle mucose con presenza di lesioni attive localizzate a livello del cavo orale
    - Esecuzione di trattamento di igiene dentale preventiva
    - Paziente in situazione clinica stabile, ovvero in terapia immunosoppressiva stabile da almeno 8 settimane e/o in terapia cortisonica sistemica con dosaggio di prednisone o equivalente costante nelle ultime 4 settimane e minore o uguale a 10 mg/die
    - Capacità di comprendere i requisiti dello studio, accordare il consenso informato e di aderire alle procedure previste dal protocollo dello studio
    E.4Principal exclusion criteria
    - Under 18 years of age or over 90
    - Modification in immunosuppressive treatments in the last 8 weeks before the beginning of the study
    - Treatment with rituximab in the 6 moths before the study
    - Hypersesitivity to clobetasol
    - Pregnancy of brestfeeding or women planning a pregnancy
    - Partecipation to other clinical trial in the 3 moths before the beginning of the study
    - Età inferiore ai 18 anni o superiore ai 90
    - Variazione del dosaggio di terapia immunosoppressiva nelle 8 settimane precedenti all’inizio dello studio
    - Infusione di rituximab nei 6 mesi precedenti all’inizio dello studio
    - Nota ipersensibilità al principio attivo
    - Donne in gravidanza o in allattamento o che prevedono di iniziare una gravidanza durante lo studio
    - Paziente che ha partecipato ad altro studio clinico negli ultimi 3 mesi dalla visita al basale
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the safety of the product (number, entity, severity and nature of possible side effects whit CTCAE scale)
    Sicurezza del prodotto in uso (mediante valutazione del numero e dell'entità, serietà e natura di eventi avversi o effetti collaterali mediante scala CTCAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the beginning to the end of the study
    Tutta la durata dello studio
    E.5.2Secondary end point(s)
    Tolerability (number of patients who complete the course of therapy, administration of questionnaires); Change in MMPDAI score in V0, after 30, 60 and 90 days; Change in VAS pain score in V0, after 30, 60 and 90 days; Change of VAS burn score in V0, after 30, 60 and 90 days; Change of DLQUI score in V0, after 30, 60 and 90 days; Improvement of CGIC score; Improvement of PGIC; Days needed to heal oral lesions
    Tollerabilità (numero di pazienti che completano la terapia, utilizzo di questionari da somministrare ai pazienti); Variazione rispetto al punteggio ottenuto al basale (V0) dopo 30, 60 e 90 giorni dall'inizio dello studio dei punteggi di MMPDAI; Variazione rispetto al punteggio ottenuto al basale (V0) dopo 30, 60 e 90 giorni dall'inizio dello studio dei punteggi di VAS dolore; Variazione rispetto al punteggio ottenuto al basale (V0) dopo 30, 60 e 90 giorni dall'inizio dello studio dei punteggi di VAS bruciore; Variazione rispetto al punteggio ottenuto al basale (V0) dopo 30, 60 e 90 giorni dall'inizio dello studio dei punteggi di DLQI; Miglioramento clinico globale secondo il clinico (CGIC); Miglioramento clinico globale secondo il paziente (PGIC); Tempo di riepitelizzazione delle lesioni (in giorni)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the beginning to the end of the study; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60 and day 90; Day 1 (V0), day 30, day 60, day 90; Day 30, 60 and 90; Day 30, 60, 90; Day 30, 60, 90
    Tutta la durata dello studio; Giorno 1 (V0), giorno 30, giorno 60 e giorno 90; Giorno 1 (V0), giorno 30, giorno 60 e giorno 90; Giorno 1 (V0), giorno 30, giorno 60 e giorno 90; Giorno 1 (V0), giorno 30, giorno 60, giorno 90; Giorno 30, 60, 90; Giorno 30, 60, 90; Giorno 30, 60, 90
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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 followed up as per clinical practice
    I pazienti proseguiranno con il consueto monitoraggio clinico
    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 Decision2023-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-31
    P. End of Trial
    P.End of Trial StatusOngoing
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