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    Summary
    EudraCT Number:2018-003171-35
    Sponsor's Protocol Code Number:IgPro20_3007
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-09-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003171-35
    A.3Full title of the trial
    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)
    Étude destinée à évaluer l'efficacité, la sécurité et la pharmacocinétique d'IgPro20 (immunoglobuline sous-cutanée, Hizentra®) chez les adultes atteints de dermatomyosite (DM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with dermatomyositis (DM)
    Étude visant à évaluer l'efficacité, la sécurité et la pharmacocinétique de l'IgPro20 chez l'adulte atteint de dermatomyosite (DM)
    A.4.1Sponsor's protocol code numberIgPro20_3007
    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 SponsorCSL Behring LLC
    B.1.3.4CountryUnited States
    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 supportCSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring GmbH
    B.5.2Functional name of contact pointTrial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressEmil-von-Behring-Strasse 76
    B.5.3.2Town/ cityMarburg
    B.5.3.3Post code35041
    B.5.3.4CountryGermany
    B.5.4Telephone number+1610878 4000
    B.5.6E-mailclinicaltrials@cslbehring.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 Yes
    D.2.1.1.1Trade name Hizentra
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring Gmbh
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namehuman immunoglobulin G
    D.3.2Product code IgPro20
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman immunoglobulin G
    D.3.9.2Current sponsor codeIgPro20
    D.3.9.3Other descriptive nameHizentra
    D.3.9.4EV Substance CodeSUB127300
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Yes
    D.3.11.7Plasma derived medicinal product Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dermatomyositis
    Dermatomyosite
    E.1.1.1Medical condition in easily understood language
    Dermatomyositis is an uncommon inflammatory disease marked by muscle weakness and a distinctive skin rash.
    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 LLT
    E.1.2Classification code 10001403
    E.1.2Term Adult dermatomyositis
    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
    The primary objective of this study is to assess the efficacy of IgPro20 SC doses in comparison to placebo in adult subjects with DM, as measured by responder status based on the Total Improvement Score (TIS) assessments.
    L'objectif principal de cette étude est l'évaluation de l'efficacité d'IgPro20 en dose SC hebdomadaire par rapport au placebo chez les patients adultes atteints de DM, mesurée par le statut de répondeur au Score d'amélioration totale (Total Improvement Score, TIS).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to assess the efficacy, with additional clinical outcome measures, of IgPro20 in comparison to placebo, the safety of IgPro20 in comparison to placebo, and the long-term safety and efficacy of IgPro20
    Les objectifs secondaires de l'étude sont : l'évaluation de l'efficacité, grâce à des mesures supplémentaires de résultats cliniques, de l'IgPro20 par rapport au placebo ainsi que la sécurité et l'efficacité à long terme de l'IgPro20.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    male or female subjects ≥ 18 years of age with diagnosis of at least probable (idiopathic inflammatory myopathies) IIM per EULAR/ACR Classification Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation, disease activity defined by presence of DM rash / manifestation or an objective disease activity measure, and disease severity defined by Physician global visual analog scale (VAS) with a minimum value of 2.0 cm on a 10 cm scale and MMT-8 ≤ 142 or CDASI total activity score ≥ 14.
    Patients (homme ou femme), âgés de 18 ans ou plus, ayant un diagnostic au moins probable de myopathie inflammatoire idiopathique (MII) selon les critères de classification ACR/EULAR qui comprennent la confirmation d'éruptions cutanées/manifestations de dermatomyosite (DM), une activité de la maladie définie par la présence d'éruptions cutanées/manifestations de DM, une mesure objective de l'activité de la maladie et un niveau de sévérité de la maladie définie par l'échelle visuelle analogique (EVA) globale du médecin atteignant au moins 2,0 cm sur 10 cm, ainsi qu'un score MMT-8 ≤ 142 et un score d'activité totale CDASI ≥ 14.
    E.4Principal exclusion criteria
    Cancer-associated myositis, evidence of active malignant disease or malignancies diagnosed within the previous 5 years, Physician Global Damage ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
    Myosite associée à un cancer, signes de maladies ou tumeurs malignes diagnostiquées dans les 5 années précédentes, score Physician Global Damage ≥ 3 ou amélioration clinique pertinente entre la visite de sélection et l'inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Responder rate
    Taux de répondeurs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 17, 21, and 25
    Semaines 17, 21, et 25
    E.5.2Secondary end point(s)
    1. Mean Total Improvement Score (TIS),
    2. Point estimates and 95% CI for mean difference (IgPro20 – placebo) in TIS,
    3. Mean changes from Baseline in Manual Muscle Testing (MMT-8),
    4. Point estimates and 95% CI for mean change difference (IgPro20 – placebo) in MMT-8,
    5. Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score,
    6. Point estimates and 95% CI for mean change difference (IgPro20 – placebo),
    7. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% ,
    8. Percentage and 95% CI of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
    9. Point estimates and 95% CI for the odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
    10. Mean TIS throughout the study,
    11. Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points,
    12. Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS,
    13. Percentage of subjects achieving TIS ≥ 20 points at the end of the study participation,
    14. Mean changes in individual CSMs except muscle enzymes and CDASI from Baseline,
    15. Mean changes in individual CSMs except muscle enzymes and CDASI from Week 25,
    16. Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice,
    17. Percentage of subjects meeting DOW at least once, twice, or > twice,
    18. Time to meeting DOW for the first time,
    19. Number of subjects meeting DOW and receiving rescue corticosteroid treatment,
    20. Percentage of subjects meeting DOW and receiving rescue corticosteroid treatment,
    21. Number of subjects who start oral corticosteroid dose taper,
    22. Percentage of subjects who start oral corticosteroid dose taper,
    23. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    24. Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    25. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    26. Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%,
    27. Percentage of subjects receiving rescue corticosteroid treatment,
    28. Percentage of subjects whose rescue corticosteroid treatment is tapered,
    29. Time to first intake of rescue corticosteroid treatment,
    30. Number of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L,
    31. Percentage of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L,
    32. Number of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25,
    33. Percentage of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25,
    34. Percentage of subjects with Treatment Emergent Adverse Events (TEAEs),
    35. Percentage of subjects with related TEAEs,
    36. Percentage of subjects with serious TEAEs,
    37. Rate of TEAEs per infusion,
    38. Rate of TEAEs per infusion, by severity,
    39. Rate of related TEAEs per infusion,
    40. Rate of serious TEAEs per infusion.
    1. Score d'amélioration totale moyen (TIS),
    2. Estimations aux points temps et IC à 95 % pour la différence moyenne (IgPro20 – placebo) dans le score TIS,
    3. Variations moyennes du score MMT-8 depuis l'inclusion,
    4. Estimations aux points temps et IC à 95 % pour la différence de variation moyenne (IgPro20 – placebo) du score MMT-8,
    5. Variations moyennes du score d'activité totale Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) depuis l'inclusion,
    6. Estimations aux points temps et IC à 95 % pour la différence de variation moyenne (IgPro20 – placebo),
    7. Nombres de patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %,
    8. Pourcentage et IC à 95 % des patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %,
    9. Estimations aux points temps et IC à 95 % pour le rapport de cotes (IgPro20 – Placebo) des patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %,
    10. Score TIS moyen pendant toute la durée de l'étude,
    11. Pourcentage de patients obtenant un score TIS ≥ 20, ≥ 40, et ≥ 60 points,
    12. Délai nécessaire pour obtenir pour la première fois un score TIS ≥ 20, ≥ 40, et ≥ 60 points,
    13. Pourcentage de patients obtenant un score TIS ≥ 20 points à la fin de leur participation à l'étude,
    14. Variations moyennes des mesures individuelles de base, à l'exception des enzymes musculaires et du score CDASI depuis l'inclusion,
    15. Variations moyennes des mesures individuelles de base, à l'exception des enzymes musculaires et du score CDASI, à partir de la semaine 25,
    16. Pourcentage de patients remplissant les conditions de la définition d'aggravation (Definition of Worsening, DOW), au moins une fois, deux fois ou plus de deux fois,
    17. Délai nécessaire pour remplir les conditions DOW pour la première fois,
    18. Nombre de patients remplissant les conditions DOW et recevant une corticothérapie de secours,
    19. Pourcentage de patients remplissant les conditions DOW et recevant une corticothérapie de secours,
    21. Nombre de patients commençant à diminuer la dose de corticoïde oral,
    22. Pourcentage de patients commençant à diminuer la dose de corticoïde oral,
    23. Nombre de patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %, 50 %, 75 %,
    24. Nombre de patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %, 50 %, 75 %,
    25. Pourcentage de patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %, 50 %, 75 %,
    26. Pourcentage de patients susceptibles de diminuer la dose de corticoïde oral d'au moins 25 %, 50 %, 75 %,
    27. Pourcentage de patients recevant une corticothérapie de secours,
    28. Pourcentage de patients dont la corticothérapie de secours a diminué,
    29. Délai avant la première prise de la corticothérapie de secours,
    30. Nombre de patients connaissant une amélioration d'au moins 1 niveau, 2 niveaux et plus de 2 niveaux de leur mobilité, leurs soins personnels et leurs activités quotidiennes depuis l'inclusion selon l'EQ-
    5D-5L,
    31. Pourcentage de patients connaissant une amélioration d'au moins 1 niveau, 2 niveaux et plus de 2 niveaux de leur mobilité, leurs soins personnels et leurs activités quotidiennes depuis l'inclusion selon l'EQ-5D-5L,
    32. Nombre de patients ne connaissant aucune diminution des niveaux, d'au moins 1 niveau, 2 niveaux et plus de 2 niveaux d'amélioration de leur mobilité, leurs soins personnels et leurs activités quotidiennes selon l'EQ-5D-5L depuis la semaine 25,
    33. Pourcentage de patients ne connaissant aucune diminution des niveaux d'au moins 1 niveau, 2 niveaux et plus de 2 niveaux d'amélioration de leur mobilité, leurs soins personnels et leurs activités quotidiennes selon l'EQ-5D-5L depuis la semaine 25,
    34. Pourcentage de patients présentant des EI survenus en cours de traitement (EIt),
    35. Pourcentage de patients présentant des EI apparentés aux EI survenus sous traitement (EIt),
    36. Pourcentage de patients présentant des EI graves survenus sous traitement,
    37. Taux d'EI graves survenus sous traitement, par perfusion,
    38. Taux d'EI graves survenus sous traitement, par perfusion, selon la gravité,
    39. Taux d'EI apparentés aux EI survenus sous traitement (EIt) par perfusion,
    40. Taux d'EI graves survenus sous traitement, par perfusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Week 25,
    2. Up to Week 25,
    3. Up to Week 25,
    4. Up to Week 25,
    5. Up to Week 25,
    6. Up to Week 25,
    7. Up to Week 25,
    8. Up to Week 25,
    9. Up to Week 25,
    10. Baseline up to Week 53,
    11. Up to Week 53,
    12. Up to Week 53,
    13. Up to Week 53,
    14. Up to Week 25,
    15. Week 25 to Week 53,
    16. Week 9 up to Week 25,
    17. Week 9 up to Week 25,
    18. Week 9 up to Week 25,
    19. Week 9 up to Week 25,
    20. Week 9 up to Week 25,
    21. Up to Week 25,
    22. Up to Week 25,
    23. Up to Week 25,
    24. Up to Week 53,
    25. Up to Week 25,
    26. Up to Week 53,
    27. Week 9 up to Week 25,
    28. Week 9 up to Week 25,
    29. Week 9 up to Week 25,
    30. Up to Week 25,
    31. Up to Week 25,
    32. Up to Week 53,
    33. Week 25 up to Week 53,
    34-40. Up to Week 56.
    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 Yes
    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) 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Canada
    European Union
    Japan
    Mexico
    Russian Federation
    Switzerland
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    Dernière visite dernier patient
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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: 94
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 126
    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)
    None
    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 Decision2019-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-24
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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