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    Summary
    EudraCT Number:2022-000666-17
    Sponsor's Protocol Code Number:RR37_21_01
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-05-05
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-000666-17
    A.3Full title of the trial
    A Phase II double-blind, randomised, placebo-controlled study of efficacy and safety of Vibrio alginolyticus collagenase administered to patients with Dupuytren contracture
    Eine doppelblinde, randomisierte, placebokontrollierte Phase-2-Studie zur Beurteilung der Wirksamkeit und Sicherheit der Anwendung von Kollagenase aus Vibrio alginolyticus bei Patienten mit Dupuytren-Kontraktur
    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
    A.3.2Name or abbreviated title of the trial where available
    Vibrio alginolyticus collagenase Phase 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 Spa
    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 Spa
    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 pointClinical Research
    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.5.3.4CountryItaly
    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.3.4Pharmaceutical form Lyophilisate and solvent for solution for injection
    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.3.8INN - Proposed INNVibrio alginolyticus collagenase
    D.3.9.1CAS number 9001-12-1
    D.3.9.3Other descriptive nameIOPHAGUS COLLAGENASE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 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 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 placeboLyophilisate and solvent for solution for injection
    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
    Dupuytren-Kontraktur
    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)
    Zustand, bei dem ein oder mehrere Finger in einer gebeugten Position dauerhaft gebogen werden (sogenannte Dupuytren-Kontraktur)
    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.
    Evaluierung der Wirksamkeit von bis zu 3 Injektionen von Kollagenase aus V. alginolyticus in den betroffenen Strang des Primärgelenks (MP oder PIP) in Hinblick auf den klinischen Erfolg der Behandlung der Dupuytren-Kontraktur im Vergleich zu einem entsprechenden Placebo.
    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.
    1. Evaluierung der Wirksamkeit von bis zu 3 Injektionen von Kollagenase aus V. alginolyticus in den betroffenen Strang des Primärgelenks in Hinblick auf eine klinische Verbesserung der Dupuytren-Kontraktur im Vergleich zu einem entsprechenden Placebo 2. Evaluierung der zum Erzielen eines klinischen Erfolgs erforderlichen durchschnittlichen Anzahl an Injektionen von Kollagenase aus V. alginolyticus in den betroffenen Strang des Primärgelenks im Vergleich zu einem entsprechenden Placebo
    3. Evaluierung der erforderlichen medianen Zeit, die zum Erzielen und Aufrechterhalten eines klinischen Erfolgs nach der letzten Injektion von Kollagenase aus V. alginolyticus in den betroffenen Strang des Primärgelenks erforderlich ist, im Vergleich zu einem entsprechenden Placebo.
    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. Informierte Einwilligung: unterzeichnete schriftliche Einwilligungserklärung vor dem Einschuss in die Studie
    2. Geschlecht und Alter: Männer/Frauen, ≥ 18 Jahre
    3. Dupuytren-Kontraktur: Diagnose einer Dupuytren-Kontraktur mit fixierten Beugedefizit ≥ 20° und ≤ 100°, wenn es sich um ein MP-Gelenk handelt, oder ≥ 20° und ≤ 80°, wenn es sich um ein PIP-Gelenk handelt, an mindestens einem Finger, Daumen ausgenommen, verursacht durch einen tastbaren Strang, der nach Einschätzung des Prüfarztes positiv auf die Behandlung mit Kollagenase ansprechen könnte
    4. Völliges Verständnis: Fähigkeit, die Art und den Zweck der Studie, einschließlich der möglichen Risiken und Nebenwirkungen, vollständig zu verstehen; Fähigkeit, mit dem Prüfarzt zu kooperieren und den Anforderungen der gesamten Studie zu entsprechen
    5. Empfängnisverhütung und Fruchtbarkeit (nur Frauen): Gebärfähige Frauen müssen mindestens eine der folgenden zuverlässigen Verhütungsmethoden anwenden:
    a. Orale, implantierbare, transdermale oder injizierbare hormonelle Verhütungsmittel für mindestens 2 Monate vor dem Screening-Termin
    b. Ein nicht-hormonelles Intrauterinpessar (IUD) oder ein Frauenkondom mit Spermizid oder einen Verhütungsschwamm mit Spermizid oder ein Diaphragma mit Spermizid oder eine Portiokappe mit Spermizid für mindestens 2 Monate vor dem Screening-Termin
    c. Männlicher Sexualpartner, der einverstanden ist, ein Männerkondom mit Spermizid zu verwenden
    d. Steriler Sexualpartner
    e. Sexuelle Enthaltsamkeit
    Nicht-gebärfähige Frauen oder Frauen, die sich seit mindestens einem Jahr in der Postmenopause befinden, können in die Studie aufgenommen werden.
    Für alle gebärfähigen Frauen muss beim Screening und an Tag 1, vor der Dosisgabe, ein negativer Schwangerschaftstest vorliegen.
    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. Frühere Behandlungen der Dupuytren-Kontraktur: frühere Behandlungen der Dupuytren-Kontraktur einschließlich Nadelaponeurotomie (perkutane Nadelfasziotomie) oder Injektion von Verapamil oder Interferon in das ausgewählte Primärgelenk
    2. Frühere chirurgische Behandlungen der Dupuytren-Kontraktur: frühere Fasziektomie oder chirurgische Fasziotomie an der Hand des primären Gelenks
    3. Frühere Behandlung mit Kollagenase aus Clostridium histolyticum oder Vibrio alginolyticus
    4. Erkrankungen der Hand: chronische muskuläre, neurologische oder neuromuskuläre Erkrankungen der Hände
    5. Blutungen und Antikoagulanzien: Vorgeschichte von Blutungen oder Behandlung mit Antikoagulanzien in den 7 Tagen vor dem Screening, unter Ausnahme der täglichen Einnahme von Aspirin
    6. Allergie: nachgewiesene oder vermutete Überempfindlichkeit gegenüber Kollagenase und/oder dem Verdünnungsmittel der Zubereitung und/oder Hilfsstoffen; Vorgeschichte einer anaphylaktischen Reaktion auf Arzneimittel oder allergischer Reaktionen im Allgemeinen, die sich nach Ansicht des Prüfarztes auf das Ergebnis der Studie auswirken könnten
    7. Krankheiten: signifikante Vorgeschichte kardiovaskulärer Erkrankungen, einschließlich einer bekannten rezenten Vorgeschichte von Schlaganfall oder Hauterkrankungen, oder endokriner oder neurologischer Krankheiten, welche die Hände betreffen, oder anderer medizinischer Umstände, die sich nach Ansicht des Prüfarztes störend auf das Studienziel auswirken könnten
    8. Medikamentöse Behandlungen: Einnahme von Tetracyclinen, Anthracyclinderivaten, Chinolon- oder Fluorchinolon-Antibiotika in den 14 Tagen vor dem Screening
    9. Arzneimittelprüfstudien: Teilnahme an der Evaluierung von Prüfpräparaten in den 30 Tagen vor dieser Studie
    10. Schwangerschaft (gilt nur für gebärfähige Frauen): positives Ergebnis oder Fehlen eines Schwangerschaftstests beim Screening oder an Tag 1, schwangere oder stillende Frauen.
    E.5 End points
    E.5.1Primary end point(s)
    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.
    Anteil der Patienten, bei denen ein klinischer Erfolg erzielt wird, bestehend in einer Verringerung der Kontraktur von der Baseline auf ≤5°

    Bei der Evaluierung der einzelnen Endpunkte werden das MP- und das PIP- Gelenk kumulativ und getrennt bewertet.
    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
    innerhalb 30±3 Tagen nach der letzten Injektion von Kollagenase aus V. alginolyticus oder einem entsprechenden Placebo in den Strang des betroffenen Primärgelenks und gemessen am passiven Winkel der Fingerstreckung
    E.5.2Secondary end point(s)
    Proportion of patients who achieve a clinical improvement defined as a reduction from baseline in contracture by ≥50%
    Anteil der Patienten, bei denen eine klinische Verbesserung erzielt wird, bestehend in einer Verringerung der Kontraktur von der Baseline um ≥ 50 %
    E.5.2.1Timepoint(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
    innerhalb 30±3 Tagen nach der letzten Injektion von Kollagenase aus V. alginolyticus oder einem entsprechenden Placebo in den Strang des betroffenen Primärgelenks und gemessen am passiven Winkel der Fingerstreckung.
    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 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 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 concerned2
    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 No
    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
    The study will be considered terminated at the date of LSLV or upon completion of any followup procedure described in protocol.
    Die Studie gilt zum Zeitpunkt der LSLV oder nach Abschluss eines im Protokoll beschriebenen Nachsorgeverfahrens als beendet.
    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 state12
    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
    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 Decision2022-07-30
    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 StatusCompleted
    P.Date of the global end of the trial2023-11-10
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