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    Summary
    EudraCT Number:2021-004706-22
    Sponsor's Protocol Code Number:ImlifidARDSe.01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-09-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2021-004706-22
    A.3Full title of the trial
    Imlifidase in ANCA-associated vasculitis
    Imlifidase in der Behandlung der ANCA-assoziierten Vaskulitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imlifidase for the treatment of autoimmune-mediated small blood vessel inflammation
    Imlifidase zur Behandlung von autoimmun-vermittelter Entzündung der kleinen Blutgefäße
    A.3.2Name or abbreviated title of the trial where available
    ImlifidARDSe
    ImlifidARDSe
    A.4.1Sponsor's protocol code numberImlifidARDSe.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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportHansa Biopharma
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointMedizinische Klinik mit Schwerpunkt
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450665277
    B.5.6E-mailadrian.schreiber@charite.de
    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 Idefirix
    D.2.1.1.2Name of the Marketing Authorisation holderHansa Biopharma
    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 nameIdefirix
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNImlifidase
    D.3.9.3Other descriptive nameImmunoglobulin G cleaving cystein protease derived from E. coli
    D.3.9.4EV Substance CodeSUB194312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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 No
    D.3.11.9Recombinant medicinal product Yes
    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
    Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis with severe diffuse alveolar hemorrhage
    Anti-Neutrophile cytoplasmatische Antikörper (ANCA) assoziierte Vaskulitis mit schwerer diffuser alveolärer Hämorrhagie
    E.1.1.1Medical condition in easily understood language
    Auto-immune inflammation of the lungs with severe bleeding
    Auto-immun vermittelte Entzündung der Lunge mit schwerer Blutung
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10072579
    E.1.2Term Granulomatosis with polyangiitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10063344
    E.1.2Term Microscopic polyangiitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10037314
    E.1.2Term Pulmonary alveolar hemorrhage
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Define efficacy of imlifidase plus standard of care (SoC) in severe ANCA-associated vasculitis with pulmonary hemorrhage
    Definition der Effektivität von Imlifidase plus Standardbehandlung für Patienten mit pulmonaler Hämorrhagie durch ANCA-assoziierte Vaskulitis
    E.2.2Secondary objectives of the trial
    Define impact of imlifidase plus SoC on clinical and laboratory parameters
    Assess safety of imlifidase plus SoC in severe ANCA-associated vasculitis with pulmonary hemorrhage
    Untersuchung des Einflusses von Imlifidase plus Standardbehandlung auf klinische und laborchemische Parameter
    Untersuchung der Sicherheit von Imlifidase plus Standardbehandlung bei Patienten mit pulmonaler Hämorrhagie durch ANCA-assoziierte Vaskulitis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. New or previous clinical diagnosis of ANCA-associated vasculitis, (granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) consistent with revised Chapel Hill definitions
    2. ANCA titer >= 50 (AU/ml) (i.e. anti-myeloperoxidase / anti-proteinase 3) no more than 14 days prior to inclusion measured by certified clinical laboratory
    3. Pulmonary hemorrhage due to active vasculitis defined by the following:
    o A compatible chest x-ray or CT scan (diffuse pulmonary infiltrates)
    o The absence of an alternative explanation for all pulmonary infiltrates (i.e. volume overload or pulmonary infection)
    o At least one of the following:
     Evidence of alveolar hemorrhage on bronchoscopic examination or increasingly bloody returns with bronchoalveolar lavage
     Observed hemoptysis
     Unexplained anemia (<10 g/dL) or documented drop in hemoglobin (>1 g/dL) from less than 10g/dl
     Acute respiratory distress syndrome (ARDS, according to Berlin definition)
    4. Provision of written informed consent by patients before any study related procedure
    5. Willingness and ability to comply with the protocol
    6. For female subjects: Confirmed post-menopausal state (defined as amenorrhea for at least 12 months)

    1. Neue oder frühere klinische Diagnose einer ANCA-assoziierten Vaskulitis (Granulomatose mit Polyangiitis (GPA) oder mikroskopische Polyangiitis (MPA) gemäß den überarbeiteten Chapel Hill-Definitionen)
    2. ANCA-Titer >= 50 (AU/ml) (d. h. Anti-Myeloperoxidase/Antiproteinase 3), gemessen von einem zertifizierten klinischen Labor nicht länger als 14 Tage vor dem Einschluss
    3. Lungenblutung aufgrund einer aktiven Vaskulitis, definiert durch die folgenden Kriterien:
    o Ein kompatibles Röntgenbild oder CT-Scan der Brust (diffuse Lungeninfiltrate)
    o Fehlen einer alternativen Erklärung für alle pulmonalen Infiltrate (d. h. Volumenüberlastung oder pulmonale Infektion)
    o Mindestens einer der folgenden Punkte:
     Nachweis von Alveolarblutungen bei der bronchoskopischen Untersuchung oder zunehmend blutiger Rückfluss bei bronchoalveolärer Lavage
     Beobachtete Hämoptysen
     Ungeklärte Anämie (<10 g/dl) oder dokumentierter Abfall des Hämoglobins (>1 g/dl) von weniger als 10g/dl
     Akutes Atemnotsyndrom (ARDS, gemäß der Berliner Definition)
    4. Schriftliche Einverständniserklärung der Patienten vor einem studienbezogenen Verfahren
    5. Bereitschaft und Fähigkeit zur Einhaltung des Protokolls
    6. Für weibliche Probanden: Bestätigter postmenopausaler Zustand (definiert als Amenorrhoe seit mindestens 12 Monaten)
    E.4Principal exclusion criteria
    1. Subjects aged < 18 or > 80 years
    2. Subjects physically or mentally unable to give written informed consent
    3. Subjects deprived of freedom i.e., detainment or commitment to psychiatric ward, prison or state institution by law court or legal authority
    4. Female subjects: pregnant or breastfeeding or of childbearing potential
    5. Male subjects: unwilling to use double-barrier contraception for the duration of this study.
    6. Concomitant autoimmunological disease (e.g. Goodpasture, vasculitis other than AAV)
    7. Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) consistent with revised Chapel Hill definitions
    8. Concomitant pulmonary disease (e.g. chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD))
    9. Known allergy/sensitivity to imlifidase, IVIg and/or the respective excipients
    10. Previous treatment with imlifidase
    11. Previous or ongoing high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
    12. More than two plasma exchanges prior to administration of imlifidase within 28 days prior to inclusion
    13. Participation in an other interventional clinical trial or intake of other investigational medicinal product within 5 half-lives (or similar) of the product prior to inclusion
    14. Symptomatic congestive heart failure (NYHA class 2-4) requiring prescription medication or clinically evident peripheral edema of cardiac origin or documented evidence/history of NYHA class 2-4 heart failure
    15. A comorbidity or indication of such based on medical history, physical examination, and clinical laboratory assessments which precludes the use of cyclophosphamide, glucocorticoids, or imlifidase.
    16. Evidence of moderate or severe hepatic impairment indicated by elevated aminotransferases (ALT or AST) or bilirubin greater than double (2.0 x) the upper limit of normal (ULN)
    17. Ongoing bacterial or fungal infection requiring antibiotic /-fungal therapy (or completed within 7 days prior to inclusion). Viral infection with Hepatitis B, C and HIV (up to 14 days old negative test results are accepted); or active tuberculosis as indicated by chest X-ray. Every patient will be screened for SARS-CoV2, positive cases will be excluded.
    18. Active malignant disease or a history of malignancy within two years prior to diagnosis/infusion other than non-melanoma resected or cured skin cancer
    19. Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study other than those specified.
    20. Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
    21. Subject who might be dependent on the sponsor, the investigator or the trial site.
    1. Probanden im Alter von < 18 oder > 80 Jahren
    2. Probanden, die körperlich oder geistig nicht in der Lage sind, eine schriftliche Einwilligung nach Aufklärung zu erteilen
    3. Probanden, denen die Freiheit entzogen wurde, d. h. die von einem Gericht oder einer Justizbehörde in eine psychiatrische Abteilung, ein Gefängnis oder eine staatliche Einrichtung eingewiesen wurden
    4. Weibliche Probanden: schwanger oder stillend oder im gebärfähigen Alter
    5. Männliche Probanden: die nicht bereit sind, während der Dauer der Studie mit einer doppelten Barriere zu verhüten.
    6. Begleitende autoimmunologische Erkrankung (z. B. Goodpasture, Vaskulitis, außer AAV)
    7. Diagnose einer eosinophilen Granulomatose mit Polyangiitis (EGPA) gemäß den überarbeiteten Chapel Hill-Definitionen
    8. Begleitende Lungenerkrankung (z. B. chronisch obstruktive Lungenerkrankung (COPD), interstitielle Lungenerkrankung (ILD))
    9. Bekannte Allergie/Überempfindlichkeit gegen Imlifidase, IVIg und/oder die jeweiligen Hilfsstoffe
    10. Frühere Behandlung mit Imlifidase
    11. Vorherige oder laufende hochdosierte IVIg-Behandlung (2 g/kg) innerhalb von 28 Tagen vor der Aufnahme
    12. Mehr als zwei Plasmaaustausche vor der Verabreichung von Imlifidase innerhalb von 28 Tagen vor dem Einschluss
    13. Teilnahme an einer anderen interventionellen klinischen Studie oder Einnahme eines anderen Prüfarzneimittels innerhalb von 5 Halbwertszeiten (oder ähnlich) des Produkts vor dem Einschluss.
    14. Symptomatische kongestive Herzinsuffizienz (NYHA-Klasse 2-4), die eine medikamentöse Behandlung erfordert, oder klinisch erkennbare periphere Ödeme kardialen Ursprungs oder dokumentierte Anzeichen/Vorgeschichte einer Herzinsuffizienz der NYHA-Klasse 2-4
    15. Eine Komorbidität oder ein Hinweis auf eine solche aufgrund der Anamnese, der körperlichen Untersuchung und der klinischen Laboruntersuchungen, die den Einsatz von Cyclophosphamid, Glukokortikoiden oder Imlifidase ausschließen.
    16. Nachweis einer mittelschweren oder schweren Leberschädigung, die durch erhöhte Aminotransferasen (ALT oder AST) oder Bilirubin von mehr als dem Doppelten (2,0 x) des oberen Grenzwerts (ULN) angezeigt wird
    17. Laufende bakterielle oder pilzliche Infektion, die eine Antibiotika-/Pilztherapie erfordert (oder innerhalb von 7 Tagen vor der Aufnahme abgeschlossen wurde). Virale Infektion mit Hepatitis B, C und HIV (bis zu 14 Tage alte negative Testergebnisse werden akzeptiert); oder aktive Tuberkulose, wie durch Röntgenaufnahmen der Brust angezeigt. Jeder Patient wird auf SARS-CoV2 untersucht, positive Fälle werden ausgeschlossen.
    18. Aktive bösartige Erkrankung oder eine Vorgeschichte von Bösartigkeit innerhalb von zwei Jahren vor der Diagnose/Infusion, mit Ausnahme von nicht-melanomem, reseziertem oder geheiltem Hautkrebs
    19. Jede Erkrankung, die nach Ansicht des Prüfarztes das Risiko des Probanden durch die Teilnahme an der Studie erhöhen könnte, mit Ausnahme der genannten Erkrankungen.
    20. Vorhandensein oder Vorgeschichte einer thrombotischen thrombozytopenischen Purpura (TTP) oder bekannte familiäre Vorgeschichte von TTP
    21. Proband, der vom Sponsor, dem Prüfer oder dem Prüfzentrum abhängig sein könnte.
    E.5 End points
    E.5.1Primary end point(s)
    ANCA seroconversion (indicated by titerbelow reference range) within 24 hours of imlifidase administration
    ANCA-Titer Serokonversion (d.h. titer unterhalb des Refernzwerts) inerhalb von 24 Stunden nach Imlifidase Gabe
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after Imlifidase administration
    24 Stunden nach Imlifidase Infusion
    E.5.2Secondary end point(s)
    • Time to ANCA seroconversion (indicated by ELISA below reference range)
    • Rebound of ANCA serology greater than 50% of the initial fall in titer (i.e. rise > (ANCAmax – ANCAmin) / 2)
    • Mortality (30 days)
    • Duration of ICU stay
    • Amelioration of lung function
    o Duration of invasive ventilation / ECMO
    o Time to resolution of ARDS (measured by Horowitz Index)
    • Amelioration of kidney function
    o Upstaging of Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury (AKI) stages
    o Kidney replacement therapy-dependency at 3 and 6 months after inclusion
    - Zeit bis zur ANCA-Serokonversion (angezeigt durch ELISA unterhalb des Referenzbereichs)
    - Wiederanstieg der ANCA-Serologie um mehr als 50 % des ursprünglichen Titerabfalls (d. h. Anstieg > (ANCAmax - ANCAmin) / 2)
    - Sterblichkeit (30 Tage)
    - Dauer des Aufenthalts auf der Intensivstation
    - Verbesserung der Lungenfunktion
    o Dauer der invasiven Beatmung / ECMO
    o Zeit bis zum Abklingen des ARDS (gemessen am Horowitz-Index)
    - Verbesserung der Nierenfunktion
    o Upstaging der Nierenerkrankung: Improving Global Outcomes (KDIGO) Akute Nierenschädigung (AKI) Stadien
    o Nierenersatztherapie-Abhängigkeit nach 3 und 6 Monaten nach Einschluss
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily for the first week, then every 2-4 days for the next 3 weeks, every 4 weeks for the next 2 months, then every 6 weeks until week 24
    täglich für die erste Woche, dann alle 2-4 Tage für die nächsten 3 Wochen, dann alle 4 Wochen für die nächsten 2 Monate, dann alle 6 Wochen bis Woche 24
    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 Yes
    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.8.3 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.8.5The 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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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.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)
    All patients will receive standard of care for the entire duration of the study and thereafter.
    Alle Patienten erhalten die Standard-Behandlung der ANCA-assoziierten Vaskulitis während der gesamtem Dauer der Studie und danach.
    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 Decision2023-02-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-07
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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