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    EudraCT Number:2015-005255-27
    Sponsor's Protocol Code Number:DX-2930-04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-05
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-005255-27
    A.3Full title of the trial
    HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE).
    HELP Study ExtensionTM: Studio in aperto per la valutazione della sicurezza e dell’efficacia a lungo termine di DX-2930 per la prevenzione degli attacchi acuti di angioedema ereditario (AEE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term efficacy and safety study to evaluate DX-2930 in preventing angioedema attacks in patients with Type I and Type II hereditary angioedema (HAE)
    Studio in aperto per la valutazione della sicurezza e dell’efficacia a lungo termine di DX-2930 per la prevenzione degli attacchi acuti di angioedema nei pazienti con tipo I e III angioedema ereditario
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberDX-2930-04
    A.5.4Other Identifiers
    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 SponsorDYAX CORP.
    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 supportDyax Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVoisin Consulting
    B.5.2Functional name of contact pointClinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street Address64 avenue Pierre Grenier
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    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 Yes
    D.2.5.1Orphan drug designation numberEMA/ODD/075/15
    D.3 Description of the IMP
    D.3.1Product nameDX-2930
    D.3.2Product code [DX-2930]
    D.3.4Pharmaceutical form Solution for infusion
    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 INNLanadelumab
    D.3.9.1CAS number 1426055-14-2
    D.3.9.2Current sponsor codeDX-2930
    D.3.9.4EV Substance CodeSUB130835
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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
    Type I and Type II Hereditary Angioedema (HAE)
    Angioedema erediatrio (AAE) di tipo I e II
    E.1.1.1Medical condition in easily understood language
    HAE is a long-term and life theatening disease. HAE manifests clinically as unpredictable, intermittent attacks of edema of the face, larynx, gastrointestinal tract, limbs and/or genitalia.
    HAE è lungo termine e la malattia mortale.HAE si manifesta clinicamente come imprevedibili attacchi intermittenti di edema del volto,della laringe,il tratto gastrointestinale,arti e/o organi genitali
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10075280
    E.1.2Term Hereditary angioedema attack
    E.1.2System Organ Class 100000004850
    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 long term safety of repeated subcutaneous administrations of DX-2930
    Valutare la sicurezza a lungo termine di somministrazioni sottocutanee ripetute di DX 2930
    E.2.2Secondary objectives of the trial
    • To evaluate the long term efficacy of DX-2930 in preventing HAE attacks
    • To characterize the outer bounds of dosing frequency for DX-2930
    • Valutare l'efficacia a lungo termine di DX 2930 nella prevenzione degli attacchi di AEE
    • Caratterizzare i limiti estremi della frequenza di somministrazione di DX 2930
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female HAE subjects who are 12 years of age or older at the time of screening.
    2. Documented diagnosis of HAE (Type I or II) based on all of the following:
    • Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria).
    • Diagnostic testing results obtained during screening (or a prior DX-2930 study) that confirm HAE Type I or II: C1 inhibitor (C1-INH) functional level < 40% of the normal level. Subjects with functional C1-INH level 40-50% of the normal level may be enrolled if they also have a C4 level below the normal range. Subjects may be retested if results are incongruent with clinical history or believed by the Investigator to be confounded by recent LTP use. (It is understood that C1-INH therapy may alter the lab results of C1-INH assessments; therefore, the investigator's discretion in collaboration with Medical Monitor is advised for proper documentation of eligibility).
    • At least one of the following: Age at reported onset of first angioedema symptoms = 30 years, a family history consistent with HAE Type I or II, or C1q within normal range.
    3. A historical baseline HAE attack rate of at least 1 attack per 12 weeks
    4. Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form.
    Subjects age 12 to 17, whose caregiver has provided informed consent, are willing and able to read, understand and sign an assent form.
    5. Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study as follows:
    • Females of childbearing potential must agree to be abstinent or it is recommended to use highly effective forms of contraception from screening through 30 days after the final study visit. This includes stable doses (for 3 months prior to study screening) of combined estrogen and progestin-containing hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), progestin-only hormonal contraception associated with inhibition of ovulation, intra-uterine device (IUD, all types), or intrauterine hormone releasing systems (IUS). Notes: 1) A female whose male partner has had a vasectomy must agree to use one additional form of medically acceptable contraception. 2) Use of a male condom with or
    without spermicide or cervical cap, diaphragm or sponge with spermicide or a combination (double-barrier methods) are not considered highly effective.
    • Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months do not require
    contraception during the study.
    • Males, including males who are surgically sterile (post vasectomy), with female partners of childbearing potential must agree to be abstinent or else use a medically acceptable form of contraception from the screening period through 60 days after the final study visit.
    1.Soggetti di entrambi i sessi affetti da AEE, di età pari o superiore ai 12 anni al momento dello screening.
    2.Diagnosi documentata di AEE (tipo II o II), basata su tutti i seguenti fattori:
    • anamnesi clinica documentata coerente con AEE (episodi di gonfiore non pruriginoso, sottocutaneo o mucosale, con assenza di orticaria concomitante);
    • risultati dei test diagnostici acquisiti durante lo screening (o un precedente studio DX 2930) che confermano la presenza di AEE di tipo I o II: livello funzionale dell’inibitore della C1 esterasi (C1 INH) < 40% del livello normale. I soggetti con livello funzionale di C1 INH pari al 40 50% del livello normale possono essere arruolati se presentano anche un livello C4 inferiore ai limiti della norma. I test possono essere ripetuti nei soggetti se i risultati sono incoerenti con l’anamnesi clinica o se lo Sperimentatore ritiene che sia presente un certo grado di confondimento dovuto all’uso recente della LTP. (Resta inteso che la terapia con C1-INH può alterare i risultati di laboratorio del C1-INH; pertanto, si raccomanda la discrezionalità dello sperimentatore, in collaborazione con il responsabile del monitoraggio clinico, per un’idonea documentazione dell’eleggibilità);
    • almeno uno dei seguenti fattori: età = 30 anni al momento della segnalazione dell’esordio dei primi sintomi di angioedema, anamnesi familiare coerente con AEE di tipo I o II o C1q entro i limiti della norma.
    3.Soggetti che presentano un tasso basale anamnestico di almeno un attacco di AEE ogni 12 settimane.
    4. Soggetti adulti e caregiver dei soggetti di età inferiore a 18 anni disposti e in grado di leggere, comprendere e firmare una dichiarazione di consenso informato. Soggetti di età compresa tra 12 e 17 anni, i cui caregiver accordano il consenso informato, disposti e in grado di leggere, comprendere e firmare una dichiarazione di assenso.
    5. I soggetti maschi e femmine fertili e sessualmente attivi devono aderire ai requisiti di contraccezione per l’intera durata dello studio come indicato di seguito:
    • le donne in età fertile devono accettare di astenersi dai rapporti sessuali, oppure si raccomanda di far uso di metodi anticoncezionali altamente efficaci, a partire dallo screening fino a 30 giorni dopo la visita finale dello studio. Essi includono dosi stabili (per 3 mesi prima dello screening per lo studio) di contraccettivi ormonali a base di estrogeni e progestinici combinati associati a inibizione dell’ovulazione (orale, iniettabile o impiantabile), contraccettivi ormonali a base di soli progestinici associati a inibizione dell' ovulazione, dispositivo intrauterino (IUD di qualsiasi tipo), oppure sistemi intrauterini a rilascio ormonale (IUS). Note: 1) Una donna il cui partner è stato sottoposto a vasectomia deve impegnarsi a far uso di un metodo contraccettivo addizionale, accettabile sotto il profilo medico. 2) L’uso di un profilattico maschile con o senza spermicida, oppure di un cappuccio, diaframma o spugna cervicale con spermicida, o di una combinazione (metodi a doppia barriera) non è considerato altamente efficace.
    • le donne non potenzialmente fertili, definite come chirurgicamente sterili (status post-isterectomia, ooforectomia bilaterale o legatura tubarica bilaterale) o in postmenopausa da almeno 12 mesi non necessitano di contraccezione durante lo studio;
    • gli uomini, compresi i soggetti chirurgicamente sterili (vasectomizzati) con partner femmine potenzialmente fertili devono accettare di astenersi dai rapporti sessuali, oppure di far uso di un metodo anticoncezionale, accettabile sotto il profilo medico, a partire dallo screening fino a 60 giorni dopo la visita finale.
    E.4Principal exclusion criteria
    1. Discontinued from DX-2930-03 after enrollment for any reason.
    2. If rolling over from DX-2930-03, presence of important safety concerns that would preclude participation in this study.
    3. Concomitant diagnosis of another form of chronic, recurrent angioedema such as acquired angioedema (AAE), HAE with normal C1-INH (also known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria.
    4. Dosing with an investigational drug (not including DX-2930 or other HAE therapies) or exposure to an investigational device within 4 weeks prior to screening.
    5. Exposure to angiotensin-converting enzyme (ACE) inhibitors within 4 weeks prior to study screening or any newly initiated or dose modification of estrogen-containing medications with systemic absorption (such as oral
    contraceptives or hormonal replacement therapy) 3 months prior to the screening visit.
    6. Unwilling to discontinue use of long-term prophylactic therapy for HAE (C1-INH, attenuated androgens, or antifibrinolytics) within 3 weeks after starting DX-2930 treatment.
    7. Any of the following liver function test abnormalities: alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) > 3x upper limit of normal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's Syndrome).
    8. Pregnancy or breastfeeding.
    9. Subject has any condition that, in the opinion of the investigator or Sponsor, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the
    results (e.g., history of substance abuse or dependence, a significant pre-existing illness or other major comorbidity that the investigator considers may confound the interpretation of study
    1. Soggetti che hanno interrotto la partecipazione a DX 2930 03 dopo l’arruolamento per un motivo qualsiasi.
    2. Nei soggetti rollover dallo studio DX 2930 03, presenza di importanti problemi di sicurezza che precluderebbero la partecipazione a questo studio.
    3. Diagnosi concomitante di un’altra forma di angioedema cronico, recidivante, come angioedema acquisito (AEA), AEE con C1 INH normale (chiamato anche AEE di tipo III), angioedema idiopatico o angioedema recidivante associato a orticaria.
    4. Somministrazione di un farmaco sperimentale (non comprendente DX 2930 o altre terapie per l'AEE) o esposizione a un dispositivo sperimentale nelle 4 settimane precedenti allo screening.
    5. Esposizione agli inibitori dell’enzima di conversione dell’angiotensina (ACE) nelle 4 settimane precedenti allo screening per lo studio o nuova introduzione o modifica della dose di qualsiasi medicinale contenente estrogeni con assorbimento sistemico (come contraccettivi orali o terapia ormonale sostitutiva) 3 mesi prima della visita di screening.
    6. Indisponibilità a interrompere l'uso di terapia profilattica a lungo termine contro l’AEE (C1 INH, androgeni attenuati o antifibrinolitici) nelle 3 settimane successive all’inizio del trattamento con DX-2930.
    7. Uno qualsiasi dei seguenti risultati anomali dei test di funzionalità epatica: alanina aminotransferasi (ALT) > 3 volte il limite superiore della norma, o aspartato aminotransferasi (AST) > 3 volte il limite superiore della norma, o bilirubina totale > 2 volte il limite superiore della norma (a meno che l’innalzamento dei valori di bilirubina sia una conseguenza della sindrome di Gilbert).
    8. Gravidanza o allattamento.
    9. Soggetti che presentano una qualsiasi patologia che, a giudizio dello Sperimentatore o del Promotore, possa compromettere la loro sicurezza o compliance, precludere il successo dell’esecuzione dello studio o interferire con l’interpretazione dei risultati (ad es., anamnesi di abuso o dipendenza da sostanze, importante malattia preesistente o altra comorbilità maggiore che lo Sperimentatore ritiene possa essere un fattore confondente nell’interpretazione dei risultati dello studio).
    E.5 End points
    E.5.1Primary end point(s)
    • AEs including SAEs and AEs of special interest • Clinical Laboratory testing (hematology, clinical chemistry , coagulation and urinalysis) • Vital signs including blood pressure, heart rate, body temperature and respiratory rate • Physical examination • 12-lead ECG
    • AE compresi SAE e AESI • Analisi cliniche di laboratorio (ematologia, ematochimica, coagulazione e analisi delle urine) • Parametri vitali, comprese pressione arteriosa, frequenza cardiaca, temperatura corporea e frequenza respiratoria • Esame obiettivo • Elettrocardiogramma (ECG) a 12 derivazioni
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    E.5.2Secondary end point(s)
    Efficacy Endpoints: • Time to first HAE attack for rollover subjects (based upon time from first open label study dose until first HAE attack) • Number of investigator confirmed HAE attacks during the treatment period • Number of investigator confirmed HAE attacks requiring acute treatment during the treatment period • Number of moderate or severe HAE attacks during the treatment period • Number of high-morbidity HAE attacks during the treatment period; a high-morbidity HAE attack is defined as any attack that has at least one of the following characteristics: severe, results in hospitalization (except hospitalization for observation < 24 hours), hemodynamically significant (systolic blood pressure < 90, requires IV hydration, or associated with syncope or near-syncope) or laryngeal.
    Endpoint di efficacia • Tempo al primo attacco di AEE nei soggetti rollover (basato sul tempo intercorso tra la somministrazione della prima dose dello studio in aperto e il primo attacco di AEE) • Numero di attacchi di AEE confermati dallo sperimentatore durante il periodo di trattamento • Numero di attacchi di AEE confermati dallo sperimentatore che hanno richiesto terapia acuta durante il periodo di trattamento • Numero di attacchi di AEE moderati o severi durante il periodo di trattamento • Numero di attacchi di AEE ad alta morbilità durante il periodo di trattamento. Per attacco di AEE ad alta morbilità si intende qualsiasi attacco che presenta almeno una delle seguenti caratteristiche: severo, necessitante di ricovero in ospedale (con l’eccezione dei ricoveri per osservazione < 24 ore), emodinamicamente importante (pressione sistolica < 90, che necessita di idratazione e.v. o associato a sincope o presincope) o laringeo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 months
    30 mesi
    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 Yes
    E.6.7Pharmacodynamic Yes
    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. 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 No
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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. of subjects for this age range: 21
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 225
    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)
    After completion of the 132-week treatment period, all subjects will undergo safety evaluations during an 4-week follow-up period unless rolling over into another ongoing DX-2930 clinical study or access program that permits such a rollover. Subjects who do not rollover into another DX-2930 study or access program will continue to receive current standard of care as directed by their physician.
    Dopo il completamento del periodo di trattamento di 132 settimane, tutti i soggetti saranno sottoposti valutazioni di sicurezza nel corso di un periodo di follow-up di 4 settimane a meno ribaltamento in un altro programma di studio o l'accesso continuo DX-2930 clinica che consente un tale ribaltamento. I soggetti che non rollover in un altro programma di studio o l'accesso DX-2930 continueranno a ricevere attuale standard di cura come indicato dal loro medico.
    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 Decision2016-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-16
    P. End of Trial
    P.End of Trial StatusCompleted
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