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    Summary
    EudraCT Number:2020-000570-25
    Sponsor's Protocol Code Number:CSL312-3001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-06-04
    Trial results View 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 number2020-000570-25
    A.3Full title of the trial
    A multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema
    Studio multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a bracci paralleli teso a valutare l’efficacia e la sicurezza della somministrazione sottocutanea di CSL312 (garadacimab) nel trattamento profilattico dell’angioedema ereditario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CSL312 (garadacimab) in the prevention of hereditary angioedema attacks
    CSL312 (garadacimab) per la prevenzione degli attacchi dell'angioedema ereditario
    A.3.2Name or abbreviated title of the trial where available
    CSL312-3001
    CSL312-3001
    A.4.1Sponsor's protocol code numberCSL312-3001
    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 GMBH
    B.1.3.4CountryGermany
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSL Behring LLC
    B.5.2Functional name of contact pointTrial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street Address1020 First Avenue
    B.5.3.2Town/ cityKing of Prussia
    B.5.3.3Post codePA19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number0234964222
    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 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 nameFactor XIIa antagonist monoclonal antibody
    D.3.2Product code [CSL312]
    D.3.4Pharmaceutical form Solution for injection/infusion in pre-filled syringe
    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 INNFXIIa inhibitor monoclonal antibody
    D.3.9.2Current sponsor codeCSL312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    Hereditary angioedema
    Angioedema ereditario
    E.1.1.1Medical condition in easily understood language
    Hereditary angioedema (HAE) is a condition characterized by painful, recurring attacks of swelling in parts of the body including the face, throat, hands, feet, abdomen.
    L'angioedema ereditario (HAE) è una condizione caratterizzata da attacchi dolorosi e ricorrenti di gonfiore in parti del corpo tra cui viso, gola, mani, piedi e addome.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the efficacy of sucutaneous administration of CSL312 as prophylaxis to prevent hereditary angioedema attacks in subjects with hereditry angioedema
    L’obiettivo primario di questo studio è valutare l’efficacia della somministrazione sottocutanea di CSL312 come profilassi per la prevenzione degli attacchi di angioedema ereditario nei soggetti con angioedema ereditario.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    1. To characterize the clinical efficacy of subcutaneous CSL312 in the prophylactic treatment of hereditary angioedema
    2. to evaluate the safety of subcutaneous CSL312 in the prophylactic treatment of hereditary angioedema
    Obiettivi secondari dello studio
    1. Caratterizzare l’efficacia clinica di CSL312 somministrato per via sottocutanea nel trattamento profilattico dell’HAE.
    2. Valutare la sicurezza di CSL312 somministrato per via sottocutanea nel trattamento profilattico dell’HAE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of providing written informed consent
    2. Male or female.
    3. Aged = 12 years
    4. Diagnosed with clinically confirmed C1-INH HAE
    5. Experienced = 3 HAE attacks during the 3 months before Screening
    1. Capacità di fornire il consenso informato scritto,
    2. Maschi o femmine,
    3. Età = 12 anni
    4. Diagnosi di HAE C1-INH confermata clinicamente
    5.= 3 attacchi di HAE durante i 3 mesi prima dello screening
    E.4Principal exclusion criteria
    Concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticarial or hereditary angioedema type 3
    Diagnosi concomitante di un'altra forma di angioedema come angioedema idiopatico o acquisito, angioedema ricorrente associato ad angioedema orticarioide o ereditario di tipo 3
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time-normalized number of HAE attacks during treatment from Day 1 through Day 182.
    L’endpoint primario è il numero normalizzato nel tempo di attacchi di HAE durante il trattamento dal giorno 1 al giorno 182.
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 6 months
    fino a 6 mesi
    E.5.2Secondary end point(s)
    - The reduction in the attack rate during the Treatment Period compared to the Run-in Period.
    - The time-normalized number of HAE attacks requiring on-demand treatment.
    - The time-normalized number of moderate and / or severe HAE attacks.
    - The time-normalized number of HAE attacks at various time points during the treatment period.
    - Subject Global Assessment of Response to Treatment (SGART).
    - Adverse events (AEs).
    - Adverse events of special interest (AESIs).
    - Serious adverse events (SAEs).
    - CSL312 induced anti-CSL312 antibodies.
    - Clinically significant abnormalities in laboratory assessments
    - Riduzione della frequenza degli attacchi durante il periodo di trattamento rispetto al periodo di run-in.
    - Numero normalizzato nel tempo di attacchi di HAE che richiedono un trattamento al bisogno.
    - Numero normalizzato nel tempo di attacchi di HAE moderati e/o gravi.
    - Numero normalizzato nel tempo di attacchi di HAE in vari momenti durante il periodo di trattamento.
    - Valutazione SGART (Subject Global Assessment of Response to Treatment).
    - Eventi avversi (AE).
    - Eventi avversi di particolare interesse (AESI).
    - Eventi avversi gravi (SAE).
    - Anticorpi anti-CSL312 indotti da CSL312.
    - Anomalie clinicamente significative negli esami di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    to 1: up to 6 months
    to 2: 6 months, and first 3 months and second 3 months
    to 3: 6 months, and first 3 months and second 3 months
    to 4: First 3 months and second 3 months and 6 months
    to 5: 6 months, and first 3 months and second 3 months
    to 6: Up to 6 months
    to 7 and 8: Up to 8 months
    to 1: up to 6 months
    to 2: 6 months, and first 3 months and second 3 months
    to 3: 6 months, and first 3 months and second 3 months
    to 4: First 3 months and second 3 months and 6 months
    to 5: 6 months, and first 3 months and second 3 months
    to 6: Up to 6 months
    to 7 and 8: Up to 8 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    United States
    Germany
    Hungary
    Italy
    Netherlands
    Spain
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months19
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months19
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    Standard of care
    Standard of care
    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 Decision2021-03-01
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-09
    P. End of Trial
    P.End of Trial Status
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