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    Summary
    EudraCT Number:2022-000666-17
    Sponsor's Protocol Code Number:RR37_21_01
    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:2022-07-07
    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 number2022-000666-17
    A.3Full title of the trial
    Phase II double-blind, randomised, placebo-controlled study of efficacy and safety of Vibrio alginolyticus collagenase administered to patients with Dupuytren contracture
    Studio di fase II, in doppio cieco, randomizzato, controllato con placebo, per la valutazione dell’efficacia e della sicurezza della collagenasi da Vibrio alginolyticus somministrata a pazienti con contrattura di Dupuytren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study with placebo to evaluate the efficacy and safety of bacterial collagenase administered in patients with Dupuytren's contracture
    Studio di fase II con placebo per valutare l’efficacia e la sicurezza della collagenasi batterica somministrata a pazienti con contrattura di Dupuytren
    A.3.2Name or abbreviated title of the trial where available
    Vibrio alginolyticus collagenase Phase II
    Vibrio alginolyticus collagenasi Fase II
    A.4.1Sponsor's protocol code numberRR37_21_01
    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 SponsorFIDIA FARMACEUTICI S.P.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFidia Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCross Research SA
    B.5.2Functional name of contact pointricerca clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia F.A. Giorgioli 14
    B.5.3.2Town/ cityArzo
    B.5.3.3Post codeCH-6864
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00410916300510
    B.5.5Fax number00410916300511
    B.5.6E-mailpatrick.santoro@croalliance.com
    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 nameVibrio alginolyticus collagenase
    D.3.2Product code [Vibrio alginolyticus collagenase]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001-12-1
    D.3.9.2Current sponsor codeVibrio alginolyticus collagenase
    D.3.9.3Other descriptive nameIOPHAGUS COLLAGENASE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number72
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboPowder and solvent for solution for injection/infusion
    D.8.4Route of administration of the placeboIntralesional use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dupuytren contracture
    Contrattura di Dupuytren
    E.1.1.1Medical condition in easily understood language
    Condition in which one or more fingers become permanently bent in a flexed position (called Dupuytren contracture)
    Condizione in cui una o più dita si piegano permanentemente in posizione flessa (chiamata contrattura di Dupuytren)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10013872
    E.1.2Term Dupuytren's contracture
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the efficacy of up to 3 injections of V. alginolyticus collagenase into the affected cord in the primary joint (MP or PIP) in terms of clinical success in the treatment of the Dupuytren contracture as compared to matching placebo.
    Valutare l’efficacia di un massimo di 3 iniezioni di collagenasi da V. alginolyticus nella corda interessata presente nell’articolazione primaria (MP o PIP) in termini di successo clinico del trattamento della contrattura di Dupuytren, rispetto al placebo corrispondente.
    E.2.2Secondary objectives of the trial
    1. to evaluate the efficacy of up to 3 injections of V. alginolyticus collagenase into the affected cord in the primary joint in terms of clinical improvement of the Dupuytren contracture as compared to matching placebo 2. to evaluate the mean number of injections of V. alginolyticus collagenase into the affected cord in the primary joint necessary to achieve clinical success as compared to matching placebo 3. to evaluate the median time (in days) to achieve and maintain clinical success after the last injection of V.alginolyticus collagenase into the affected cord in the primary joint as compared to matching placebo. 4. to determine the reduction from baseline in contracture degree after the last injection of V. alginolyticus collagenase into the affected cord in the primary joint as compared to matching placebo
    1.Valutare l’efficacia di un massimo di 3 iniezioni di collagenasi da V. alginolyticus nella corda interessata presente nell’articolazione primaria in termini di miglioramento clinico della contrattura di Dupuytren, rispetto al placebo corrispondente. 2.Valutare il numero medio di iniezioni di collagenasi da V. alginolyticus nella corda interessata presente nell’articolazione primaria necessarie a raggiungere il successo clinico, rispetto al placebo corrispondente. 3.Valutare il tempo mediano necessario a raggiungere e mantenere il successo clinico dopo l’ultima iniezione di collagenasi da V. alginolyticus nella corda interessata presente nell’articolazione primaria, rispetto al placebo corrispondente.4.Determinare la riduzione rispetto al basale del grado di contrattura dopo l’ultima iniezione di collagenasi da V. alginolyticus nella corda interessata presente nell’articolazione primaria, rispetto al placebo corrispondente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent: signed written informed consent before inclusion in the study
    2. Sex and Age: men/women, =18 year old inclusive
    3. Dupuytren contracture: diagnosis of Dupuytren contracture with a fixed flexion deformity =20° and =100°, if in a MP joint, or =20° and =80°, if in a PIP joint, of at least one finger, other than the thumb, caused by a palpable cord that, according to the investigator’s judgement, could benefit from treatment with collagenase
    4. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
    5. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception:
    a. Hormonal oral, implantable, transdermal or injectable contraceptives for at least 2 months before the screening visit
    b. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit
    c. A male sexual partner who agrees to use a male condom with spermicide
    d. A sterile sexual partner
    e. Sexual abstinence
    Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted.
    For all women of child-bearing potential, pregnancy test result must be negative at screening and Day 1 at pre-dose.
    1.Consenso informato: consenso informato scritto firmato prima dell’inclusione nello studio
    2.Sesso ed età: uomini/donne, età =18 anni inclusi
    3.Contrattura di Dupuytren: diagnosi di contrattura di Dupuytren con una deformità fissa in flessione =20° e =100°, se in un’articolazione MP, o =20° e =80°, se in un’articolazione PIP, di almeno un dito diverso dal pollice, causata da una corda palpabile che, secondo il giudizio dello sperimentatore, potrebbe trarre beneficio dal trattamento con la collagenasi
    4.Comprensione totale: capacità di comprendere l’intera natura e lo scopo dello studio, compresi i possibili rischi ed effetti indesiderati; capacità di collaborare con lo sperimentatore e di rispettare i requisiti dell’intero studio
    5.Contraccezione e fertilità (solo per le donne): le donne potenzialmente fertili devono utilizzare almeno uno dei seguenti metodi affidabili di contraccezione:
    a. Contraccettivi ormonali orali, impiantabili, transdermici o iniettabili per almeno 2 mesi prima della visita di screening
    b. Dispositivo intrauterino non ormonale o preservativo femminile con spermicida o spugna contraccettiva con spermicida o diaframma con spermicida o cappuccio cervicale con spermicida per almeno 2 mesi prima della visita di screening
    c. Un partner sessuale di sesso maschile che acconsenta a utilizzare un preservativo maschile con spermicida
    d. Un partner sessuale sterile
    e. Astinenza sessuale
    Saranno ammesse le donne non potenzialmente fertili o in post-menopausa da almeno un 1 anno.
    Per tutte le donne potenzialmente fertili, dovrà essere disponibile un risultato negativo del test di gravidanza allo screening e al giorno 1 prima della somministrazione della dose.
    E.4Principal exclusion criteria
    1. Previous Dupuytren contracture treatments: previous treatments of Dupuytren contracture including needle aponeurotomy (percutaneous needle fasciotomy) or injection of verapamil or interferon on the selected primary joint
    2. Previous Dupuytren contracture surgical treatments: previous fasciectomy or surgical fasciotomy in the primary joint hand
    3. Previous treatment with Clostridium histolyticum or Vibrio alginolyticus collagenase
    4. Hand disorders: chronic muscular, neurological or neuromuscular disorders affecting hands
    5. Bleeding and anticoagulants: history of bleeding or anticoagulant therapy within 7 days of the screening with the exception of daily intake of aspirin
    6. Allergy: ascertained or presumptive hypersensitivity to collagenase and/or formulation diluent and/or excipients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
    7. Diseases: significant history of cardiovascular diseases including known recent history of stroke or skin diseases, or endocrine or neurological diseases that affected the hands or of any other medical condition which in the investigator’s opinion may interfere with the aim of the study
    8. Medications: intake of tetracyclines, anthracycline derivatives, quinolones or fluoroquinolones within 14 days before the screening
    9. Investigative drug studies: participation in the evaluation of any investigational product for 30 days before this study
    10. Pregnancy (women of child-bearing potential only): positive or missing pregnancy test at screening or Day 1, pregnant or lactating women
    1.Trattamenti precedenti della contrattura di Dupuytren: trattamenti precedenti della contrattura di Dupuytren, incluse aponeurotomia con ago (fasciotomia percutanea con ago) o iniezione di verapamil o interferone nell’articolazione primaria selezionata
    2.Trattamenti chirurgici precedenti della contrattura di Dupuytren: fasciectomia o fasciotomia chirurgica precedente nella mano dell’articolazione primaria
    3.Trattamento precedente con collagenasi da Clostridium histolyticum o da Vibrio alginolyticus
    4.Disturbi della mano: disturbi cronici muscolari, neurologici o neuromuscolari a carico delle mani
    5.Sanguinamento e anticoagulanti: anamnesi di sanguinamento o terapia anticoagulante nei 7 giorni precedenti allo screening, fatta eccezione per l’assunzione giornaliera di aspirina
    6.Allergie: ipersensibilità accertata o presunta alla collagenasi e/o al diluente e/o agli eccipienti della formulazione; anamnesi di anafilassi dovuta a farmaci o reazioni allergiche in generale, che lo sperimentatore ritenga possano influire sull’esito dello studio
    7.Malattie: anamnesi significativa di malattie cardiovascolari, compresa anamnesi recente accertata di ictus oppure malattie cutanee o endocrine o neurologiche che abbiano avuto effetti sulle mani o di qualsiasi altra condizione medica che, secondo il parere dello sperimentatore, potrebbe interferire con l’obiettivo dello studio
    8.Farmaci: assunzione di tetracicline, derivati delle antracicline, chinoloni o fluorochinoloni nei 14 giorni precedenti allo screening
    9.Studi su farmaci sperimentali: partecipazione alla valutazione di qualsiasi prodotto sperimentale nei 30 giorni precedenti a questo studio
    10.Gravidanza (solo per le donne potenzialmente fertili): test di gravidanza positivo o non disponibile allo screening o al giorno 1, donne in gravidanza o che allattano al seno
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients who achieve clinical success defined as a reduction in contracture from baseline to >=5°

    In the evaluation of each endpoint, MP and PIP joints will be evaluated cumulatively and separated
    1.Percentuale di pazienti che raggiungono il successo clinico, definito come una riduzione della contrattura rispetto al basale fino a >=5°

    Nella valutazione di ogni endpoint, le articolazioni MP e PIP saranno valutate complessivamente e separatamente.
    E.5.1.1Timepoint(s) of evaluation of this end point
    in 30±3 days after the last injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint as measured by passive angle of finger extension
    dopo 30±3 giorni dall’ultima iniezione di collagenasi da V. alginolyticus o di placebo corrispondente nella corda presente nell’articolazione interessata primaria, come misurato in termini di angolo passivo di estensione delle dita
    E.5.2Secondary end point(s)
    Median time (in days) to achieve and maintain clinical success after the last injection of V. alginolyticus collagenase or matching placebo into the affected cord in the primary joint (MP or PIP); Percentage change from baseline in contracture degree as measured by passive finger extension; Change from baseline in the range of motion; Proportion of patients who achieve clinical success defined as a reduction in contracture from baseline to=5°; Proportion of patients who achieve a clinical improvement defined as a reduction from baseline in contracture by=50%; Change from baseline in patient-reported outcome measures; Overall safety profile of injection of V. alginolyticus collagenase or matching placebo; Immunogenicity after each injection of V. alginolyticus collagenase evaluated through assay of serum antidrug antibodies in all subjects; Mean number of injections of V. alginolyticus collagenase or matching placebo into the affected cord in the primary joint (MP or PIP) necessary to achieve clinical success; Proportion of patients who achieve a clinical improvement defined as a reduction from baseline in contracture by =50%
    Tempo mediano (in giorni) per raggiungere e mantenere il successo clinico dopo l’ultima iniezione di collagenasi da V. alginolyticus o di placebo corrispondente nella corda interessata presente nell’articolazione primaria (MP o PIP).; Variazione percentuale rispetto al basale del grado di contrattura, misurata in termini di estensione passiva delle dita; Variazione rispetto al basale del raggio di movimento; Percentuale di pazienti che raggiungono il successo clinico, definito come una riduzione della contrattura rispetto al basale fino a=5°; Percentuale di pazienti che raggiungono un miglioramento clinico, definito come una riduzione della contrattura rispetto al basale di=50%; Variazione rispetto al basale degli esiti riferiti dal paziente; Profilo di sicurezza generale dell’iniezione di collagenasi da V. alginolyticus o di placebo corrispondente; Immunogenicità dopo ogni iniezione di collagenasi da V. alginolyticus, valutata mediante test degli anticorpi anti-farmaco sierici in tutti i soggetti; Numero medio di iniezioni di collagenasi da V. alginolyticus o di placebo corrispondente nella corda interessata presente nell’articolazione primaria (MP o PIP), necessario per raggiungere il successo clinico; Percentuale di pazienti che raggiungono un miglioramento clinico, definito come una riduzione della contrattura rispetto al basale di =50%
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the study; in 30±3 days after the last injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint; in 30±3 days after the last injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint; in 30±3 days after each received injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint as measured by passive angle of finger extension; in 30±3 days after each received injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint as measured by passive angle of finger extension; in 30±3 days; after 3 and 6 month; 30±3 days post-dose.; during the study; in 30±3 days after the last injection of V. alginolyticus c
    durante lo studio; dopo 30±3 giorni dall’ultima iniezione di collagenasi da V. alginolyticus o di placebo corrispondente nella corda presente nell’articolazione primaria interessata.; dopo 30±3 giorni dall’ultima iniezione di collagenasi da V. alginolyticus o di placebo corrispondente nella corda presente nell’articolazione primaria interessata.; dopo 30±3 giorni da ogni iniezione somministrata di collagenasi da V. alginolyticus o di placebo corrispondente nella corda presente nell’articolazione interessata primaria, come misurato in termini di angolo passivo di estensione delle dita.; dopo 30±3 giorni da ogni iniezione somministrata di collagenasi da V. alginolyticus o di placebo corrispondente nella corda presente nell’articolazione interessata primaria, come misurato in termini di angol
    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 No
    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 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 Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Yes
    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
    LSLV
    LSLV
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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)
    na
    na
    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 Decision2022-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-28
    P. End of Trial
    P.End of Trial StatusOngoing
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