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    Summary
    EudraCT Number:2022-002627-35
    Sponsor's Protocol Code Number:TAK-667-3001
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2022-07-25
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2022-002627-35
    A.3Full title of the trial
    A Multicenter, Open-Label, Non-randomized Phase 3 Study to Assess the Safety, Efficacy and Pharmacokinetics of Subcutaneous Administration of Icatibant (TAK-667) in Japanese Children and Adolescents with Acute Attacks of Hereditary Angioedema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Icatibant (TAK-667) in Japanese Children and Teenagers With Acute Attacks of Hereditary Angioedema
    A.4.1Sponsor's protocol code numberTAK-667-3001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04654351
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1260-2627
    A.5.4Other Identifiers
    Name:jRCT2041200073Number:jRCT
    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 SponsorTakeda Pharmaceutical Company Limited
    B.1.3.4CountryJapan
    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 supportTakeda Pharmaceutical Company Limited
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceutical Company Limited
    B.5.2Functional name of contact pointStudy Director
    B.5.3 Address:
    B.5.3.1Street Address1-1, Doshomachi 4-chome, Chuo-ku
    B.5.3.2Town/ cityOsaka
    B.5.3.3Post code540-8645
    B.5.3.4CountryJapan
    B.5.6E-mailTrialDisclosures@takeda.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 Firazyr® 30 mg subcutaneous injection Syringe: 3.0 mL×1 Syringe
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharmaceuticals International AG Ireland Branch
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameIcatibant Acetate (JAN)
    D.3.2Product code TAK-667
    D.3.4Pharmaceutical form 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 INNIcatibant
    D.3.9.1CAS number 130308-48-4
    D.3.9.2Current sponsor codeTAK-667
    D.3.9.3Other descriptive nameIcatibant
    D.3.9.4EV Substance CodeSUB08104MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hereditary Angioedema
    E.1.1.1Medical condition in easily understood language
    Repeated episodes of edema in various parts of the body
    E.1.1.2Therapeutic area Body processes [G] - Genetic Phenomena [G05]
    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
    To evaluate the safety, efficacy and PK of icatibant for the
    treatment of acute attacks in Japanese children and adolescents with type I or type II HAE.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. In the opinion of the investigator or subinvestigator, the subject’s parent or legal guardian is capable of understanding and complying with protocol requirements.
    2. The subject’s parent or the subject’s legal guardian is capable of signing and dating a written informed consent form on behalf of the subject prior to the initiation of any study procedures. Written informed assent is also obtained from the subject as much as possible.
    3. The subject is in Japan and is Japanese; defined as born in Japan and having Japanese parents and Japanese maternal and paternal grandparents.
    4. The subject is male or female and 2 to <18 years of age (ie, from the second birthday through the day prior to the eighteenth birthday) at the time of informed consent.
    5. The subject weighs ≥12 kg at the time of the current HAE attack.
    6. The subject who has a documented and confirmed diagnosis of HAE type I or II. Diagnosis may be based on historical data using the following criteria:
    a. Family history of angioedema
    b. Characteristic attack manifestations, recurrent attacks
    c. Functional C1-INH deficiency
    d. In the absence of a family history of angioedema, exclusion of other forms of angioedema (eg. ACE-induced angioedema, allergic angioedema) based on medical judgement (eg,
    concomitant medication, response to antihistamines or glucocorticoids, information of genetic mutation).
    7. If the subject does not have a documented and confirmed diagnosis of HAE type I or II based on historical data, including C1-INH deficiency, the subject’s diagnosis must be determined
    prior to treatment by C1-INH test results which demonstrate a functional C1-INH deficiency.
    a. HAE type I: Low amount of C1-INH protein and low level of C1-INH activity; HAE type II: Normal or increased amount of C1-INH protein and low level of C1-INH activity
    b. In the absence of a family history of angioedema, exclusion of other forms of angioedema (eg. ACE-induced angioedema, allergic angioedema) based on medical judgement (eg, concomitant medication, response to antihistamines or glucocorticoids, information of genetic mutation).
    8. The current HAE attack must be in the cutaneous, abdominal, and/or laryngeal (inclusive of laryngeal and pharyngeal) areas, but no prespecified attack severity criteria are required for treatment.
    9. The subject commences treatment within 12 hours after the onset of current HAE attack.
    10. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study, and proves negative in the pregnancy test at screening.
    E.4Principal exclusion criteria
    1. The subject will require an intervention to support the airway (eg, intubation, tracheotomy, cricothyrotomy) due to the current HAE attack.
    2. The subject presents with an HAE attack with laryngeal/upper respiratory tract symptoms which are considered severe in the investigator’s clinical judgment and which may necessitate urgent care and/or impede the conduct of study efficacy assessments.
    3. The subject has a diagnosis of angioedema other than HAE
    4. The subject has evidence of stroke or coronary artery disease based on medical history at the screening examination or at pretreatment; eg, acute ischemic heart disease, unstable angina pectoris, severe coronary heart disease or congestive heart failure, that in the investigator’s judgment would be a contraindication for participation in the trial (New York Heart
    Association [NYHA] class 3 and 4).
    5. The subject has received treatment with any pain medication since the onset of the current HAE attack.
    6. The subject has received replacement therapy (C1-INH products, fresh frozen plasma [FFP]) within 5 days (120 hours) from the onset of the current HAE attack.
    7. The subject has received treatment with ACE inhibitors within 7 days prior to treatment.
    8. The subject has used hormonal contraceptive within 90 days prior to treatment.
    9. The subject has received androgen or attenuated androgens (eg, danazol, testosterone) within 90 days prior to treatment.
    10. The subject has participated in another clinical study within the past 30 days before screening.
    11. The subject, the subject’s parent, or legal guardian is unable to understand the nature, scope, and possible consequences of the protocol, or is unlikely to comply with the protocol assessments, unable to return for follow up visits, or unlikely to complete the study for any reason.
    12. If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study, during the study, and within 30 days after last dose of the icatibant.
    13. The subject has a history of hypersensitivity or allergies to icatibant.
    14. The subject is judged by the investigator as being ineligible for any other reason; eg. a serious concomitant illness or condition.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of treatment-emergent adverse events (TEAEs), including injection site reactions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point will be assessed throughout the study.
    E.5.2Secondary end point(s)
    - Resting 12-lead electrocardiogram parameters in comparison to baseline
    - Vital sign measurements in comparison to baseline
    - Clinical laboratory parameters (serum chemistry, hematology and urinalysis) in comparison to baseline
    - Reproductive hormone levels in comparison to baseline
    - Immunogenicity (presence of anti-icatibant antibodies) in comparison to baseline
    - Time to onset of symptom relief and time to minimal symptom, as measured by investigatorand
    subject-reported outcomes.
    a) For all subjects (2 to <18 years of age): investigator assessment and scoring of cutaneous, abdominal, and laryngeal symptoms of acute HAE attacks by an investigator-rated symptom score.
    1. The time to onset of symptom relief
    2. The time to minimal symptoms
    b) For subjects ≥4 to <18 years of age only: subject self-assessment of HAE-related pain using the Faces Pain Scale-Revised (FPS-R).
    1. The time to onset of symptom relief
    2. The time to minimal symptoms
    c) For subjects 2 to <4 years of age only: investigator assessment of HAE-related pain using the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale.
    1. The time to onset of symptom relief
    2. The time to minimal symptoms
    - The incidence of rescue medication use
    - The proportion of subjects with worsened intensity of clinical HAE symptoms between 2 and 4 hours after treatment with SC icatibant using investigator-rated symptom scores
    - Time to initial symptom improvement reported by investigator or subject
    Time to initial symptom improvement reported by subject
    - Plasma concentrations of icatibant and its major metabolites (M-I and M-II) at 0.5, 1.0, 2.0, and 4.0 hours after the first SC injection for an initial attack
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points will be assessed throughout the study.
    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 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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 3
    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: 3
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Being pediatric age group, participants were not able to give consent, thus needed parent or legal guardians to sign consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 3
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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