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    Summary
    EudraCT Number:2018-003618-41
    Sponsor's Protocol Code Number:MOM-M281-005
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2018-003618-41
    A.3Full title of the trial
    An Open-label Extension Study of MOM-M281-004 to Evaluate the Safety, Tolerability, and Efficacy of M281 Administered to Patients with Generalized Myasthenia Gravis
    Studio di estensione in aperto di MOM-M281-004 per valutare la sicurezza, la tollerabilità e l'efficacia di M281 somministrato a pazienti affetti da miastenia grave generalizzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To further evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular disease
    ---
    A.3.2Name or abbreviated title of the trial where available
    ---
    ---
    A.4.1Sponsor's protocol code numberMOM-M281-005
    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 SponsorMOMENTA PHARMACEUTICALS, Inc
    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 supportMomenta Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMomenta Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address301 Binney Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinicaltrialinfo@momentapharma.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 nameM281
    D.3.2Product code [M281]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeM281
    D.3.9.4EV Substance CodeSUB182674
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 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
    Generalized Myasthenia gravis
    Miastenia Grave Generalizzata
    E.1.1.1Medical condition in easily understood language
    Myasthenia gravis (a neuromuscular disease)
    Miastenia grave (malattia neuromuscolare)
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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 and tolerability of M281 in patients with generalized myasthenia gravis (gMG)
    Valutare la sicurezza e la tollerabilità a lungo termine di M281 in pazienti affetti da miastenia grave generalizzata (gMG)
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy of M281, long term immunogenicity of M281 and long-term pharmacodynamic (PD) activity of M281
    Valutare l’efficacia a lungo termine di M281
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has completed the M281 POC study (ie, participated in the POC study without discontinuing study drug for reasons other than the need for rescue therapy as specified in the POC protocol, and completed the protocol-specified 8 weeks of follow-up after the last dose of study drug) and had no major eligibility deviations or other major protocol deviations in the POC study. If the patient received rescue therapy during the POC, the Medical Monitor should be consulted before the patient is enrolled in the OLE study.
    2. Has sufficient venous access to allow drug administration by infusion and blood sampling as per this OLE protocol.
    3. Is up to date on all age-appropriate vaccinations as per routine local medical guidelines.
    4. Women of childbearing potential, defined as women physiologically capable of becoming pregnant, must have a negative urine pregnancy test predose on OLE study Day 1. Menopausal women who did not have elevated follicle-stimulating hormone (FSH) at the time of enrollment in the POC study must also have a negative urine pregnancy test predose on OLE study Day 1.
    5. Women of childbearing potential (including menopausal women who did not have elevated FSH at the time of enrollment in the POC study) must agree to remain totally abstinent (ie, refrain from sexual intercourse during the study) or to consistently use a reliable and highly effective method of contraception (eg, condom plus diaphragm, condom plus spermicide, diaphragm plus spermicide, or intrauterine device or oral/injectable/implanted hormonal contraceptive used in combination with an additional barrier method) during the OLE study and for 30 days after the last M281 infusion. Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
    6. Male patients must agree to remain totally abstinent (ie, refrain from sexual intercourse during the study) or to consistently use a reliable and highly effective method of contraception (eg, condom plus diaphragm, condom plus spermicide, diaphragm plus spermicide, or intrauterine device or oral/injectable/implanted hormonal contraceptive used in combination with an additional barrier method) to avoid pregnancy of the patient's partner(s) during the OLE study and for 100 days following the last M281 infusion, unless the patient provides documentation of a vasectomy at least 6 months prior to OLE study enrollment. Male patients must also abstain from sperm donation during the OLE study and for 100 days following the last M281 infusion. Note: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method are not acceptable methods of contraception. Female condom and male condom should not be used together.
    7. A patient using herbal, naturopathic, and traditional Chinese remedies and ayurvedic and nutritional supplements is eligible if the use of these medications is acceptable to the Investigator. These remedies should be at a stable dose and regimen using the same preparation since enrollment in the POC study.
    8. Is able to understand and voluntarily provide written informed consent to participate in the long-term OLE study and comply with all study procedures for duration of the OLE study.
    1. Completamento dello studio POC con M281 (ovvero, partecipazione allo studio POC senza interrompere l'assunzione del farmaco in studio per ragioni diverse dalla necessità di terapia di salvataggio come specificato nel protocollo POC e completamento delle 8 settimane di follow-up specificate dal protocollo dopo l'ultima dose di farmaco in studio) e nessuna deviazione importante relativa all’eleggibilità o altre deviazioni importanti dal protocollo nello studio POC. Se il paziente ha ricevuto una terapia di salvataggio durante il POC, il Medical Monitor dovrà essere consultato prima che il paziente sia arruolato nello studio OLE.
    2. Presentare un sufficiente accesso venoso per consentire la somministrazione del farmaco mediante infusione e i prelievi di campioni di sangue secondo il presente protocollo OLE.
    3. È stato/a sottoposto/a a tutte le vaccinazioni adeguate per l'età come da linee guida mediche locali di routine.
    4. Le donne in età fertile, definite come donne fisiologicamente in grado di rimanere incinte, devono presentare un test di gravidanza sulle urine negativo prima della somministrazione della dose il Giorno 1 dello studio OLE. Le donne in menopausa che non presentano livelli dell’ormone follicolo-stimolante elevati al momento dell’arruolamento nello studio POC devono inoltre presentare anche un test di gravidanza sulle urine negativo prima della somministrazione della dose il Giorno 1 dello studio OLE.
    5. Le donne in età fertile (incluse le donne in menopausa che non presentavano elevati livelli di FSH al momento dell'arruolamento nello studio POC) devono accettare di praticare l’astinenza totale (ovvero astenersi dai rapporti sessuali durante lo studio) o utilizzare in modo costante un metodo di contraccezione affidabile e altamente efficace (ad esempio, preservativo più diaframma, preservativo più spermicida, diaframma più spermicida, o dispositivo intrauterino o contraccettivo ormonale orale/iniettabile/impiantato utilizzato in combinazione con un ulteriore metodo di barriera) durante lo studio OLE e per 30 giorni dopo l'ultima infusione di M281. Nota: l'astinenza periodica (metodi del calendario, di misurazione sintotermica, post-ovulazione), il coito interrotto, l'uso di soli spermicidi e il metodo dell'amenorrea da lattazione non sono metodi di contraccezione accettabili. I preservativi maschile e femminile non dovranno essere utilizzati insieme.
    6. I pazienti di sesso maschile devono accettare di praticare l'astinenza totale (ovvero, astenersi da rapporti sessuali durante lo studio) o usare in modo costante un metodo contraccettivo affidabile e altamente efficace (ad es., preservativo più diaframma, preservativo più spermicida, diaframma più spermicida o dispositivo intrauterino o contraccettivi ormonali orali/iniettabili/impiantati usati in combinazione con un ulteriore metodo di barriera) per evitare la gravidanza della/e partner del paziente durante lo studio OLE e per i 100 giorni successivi all'ultima infusione di M281, a meno che il paziente non fornisca documentazione di una vasectomia risalente ad almeno 6 mesi prima dell’arruolamento nello studio OLE. I pazienti di sesso maschile devono anche astenersi dalla donazione di sperma durante lo studio OLE e per 100 giorni dopo l'ultima infusione di M281. Nota: l'astinenza periodica (metodi del calendario, di misurazione sintotermica, post-ovulazione), il coito interrotto, l'uso di soli spermicidi e il metodo dell'amenorrea da lattazione non sono metodi di contraccezione accettabili. I preservativi maschile e femminile non dovranno essere utilizzati insieme.
    7. Un paziente che usa rimedi erboristici, naturopatici e della medicina tradizionale cinese e integratori alimentari e ayurvedici è eleggibile se l'uso di questi rimedi è accettabile per lo sperimentatore. Questi rimedi devono essere assunti a dose e regime stabili usando la stessa preparazione dall’arruolamento nello studio POC.
    E.4Principal exclusion criteria
    1. Has Myasthenia Gravis Foundation of America (MGFA) Class IVb or V disease.
    2. Met any of the stopping criteria in the POC study or discontinued study drug in the POC study for any reason (eg, adverse event [AE]) other than the need for rescue therapy as specified in the POC protocol. (If the patient received rescue therapy during the POC, the Medical Monitor should be consulted before the patient is enrolled in the OLE study.)
    3. Has current suicidal ideation or suicidal behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS) administered predose on OLE study Day 1.
    4. Currently has a serious or clinically significant infection (eg, pneumonia, biliary tract infection, diverticulitis, Clostridium difficile infection) requiring parenteral anti-infectives and/or hospitalization. Note: An uncomplicated, presumably viral, upper respiratory tract infection (eg, 'the common cold') is not an exclusion.
    5. Has current alcohol/substance abuse/dependence, or in the Investigator's opinion, shows evidence of ongoing alcohol/substance abuse/dependence.
    6. Has donated or had significant loss of whole blood (480 mL or more) within 30 days, or plasma within 14 days prior to OLE study Day 1.
    7. Has a hypersensitivity to M281 or any constituent of the study drug solution.
    8. Has had a prior severe drug reaction that included shock or severe hypersensitivity.
    9. Has liver impairment with Child-Pugh Class B or C.
    10. Has any other medical condition(s) likely to require treatment with oral or parenteral glucocorticosteroids (eg, severe asthma), or has required oral or parenteral glucocorticosteroids in the past 3 months before OLE study Day 1 for conditions other than MG (inhalational, intraarticular, topical or ocular glucocorticosteroids are not exclusionary), or taking any immunosuppressive agents not being used to treat MG.
    11. Is receiving a systemic biologic antibody for any concurrent disease.
    12. Has a QT interval corrected for heart rate (QTc) at OLE study Day 1 of >450 msec for males or >470 msec for females; or QTc >480 msec in patients with Bundle Branch Block, by the Fridericia formula.
    13. Had any of the following abnormal laboratory values based on the safety laboratory tests done at the Day 85 POC Visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase =2× upper limit of normal (ULN); or bilirubin =1.5×ULN (isolated bilirubin greater than 1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%, or if there is a prior diagnosis of Gilbert disease without any condition that causes elevation of bilirubin).
    14. Had elevated CK =2×ULN based on the safety laboratory tests done at the Day 85 POC Visit.Note: If the CK value is =2×ULN at the Day 85 POC visit, the value from the Day 113 POC Visit can be used to assess eligibility. If the value from the Day 113 POC Visit is also =2×ULN, but <5×ULN, and in the opinion ofthe investigator the patient has no CK related disease and CK level is believed to be the result of non-pathologic factors, the CK may be repeated once within 28 days and if stable/improved the patient can be enrolled.
    1. Presentare malattia di classe IVb o V secondo la Myasthenia Gravis Foundation of America (MGFA).
    2. Soddisfacimento di uno qualsiasi dei criteri di interruzione dello studio POC o interruzione dell’assunzione del farmaco in studio nello studio POC per qualsiasi motivo (ad es. evento avverso [AE]) diverso dalla necessità di terapia di salvataggio come specificato nel protocollo POC. (Se il paziente ha ricevuto una terapia di salvataggio durante il POC, il Medical Monitor dovrà essere consultato prima che il paziente sia arruolato nello studio OLE).
    3. Attuale intenzione suicida o comportamento suicida in base alla Scala di valutazione del rischio di suicidio - Columbia (C-SSRS) somministrata predose il Giorno 1 dello studio OLE.
    4. Attuale infezione seria o clinicamente significativa (ad es., polmonite, infezione delle vie biliari, diverticolite, infezione da Clostridium difficile) che richiede anti-infettivi per via parenterale e/o ricovero ospedaliero. Nota: un’infezione non complicata, presumibilmente virale, delle vie respiratorie superiori (ad esempio, "il raffreddore comune") non rientra nei criteri di esclusione.
    5. Attuale abuso/dipendenza da alcol/sostanze stupefacenti o, secondo il parere dello sperimentatore, evidenza di abuso/dipendenza da alcol/sostanze stupefacenti in corso.
    6. Donazione o significativa perdita di sangue intero (480 ml o più) entro 30 giorni o di plasma entro 14 giorni prima del Giorno 1 dello studio OLE.
    7. Ipersensibilità a M281 o a qualsiasi altro componente della soluzione di farmaco in studio.
    8. Precedente reazione grave al farmaco che ha compreso shock o grave ipersensibilità.
    9. Insufficienza epatica di Classe B o C secondo la classificazione di Child Pugh.
    10. Qualsiasi altra condizione medica che possa richiedere un trattamento con glucocorticosteroidi per via orale o parenterale (ad es. asma grave) o abbia richiesto glucocorticosteroidi per via orale o parenterale negli ultimi 3 mesi prima del Giorno 1 dello studio OLE per condizioni diverse da MG (i glucocorticosteroidi per via inalatoria, intraarticolare, topica o oculare non sono motivo di esclusione) o l'assunzione di agenti immunosoppressivi non utilizzati per il trattamento della MG.
    11. Trattamento con un anticorpo biologico sistemico per qualsiasi malattia concomitante.
    12. Intervallo QT corretto per la frequenza cardiaca (QTc) il Giorno 1 dello studio OLE di >450 msec per i maschi o >470 msec per le femmine; o QTc >480 msec in pazienti con blocco di branca, secondo la formula di Fridericia.
    13. Aver presentato anomalia di uno qualsiasi dei seguenti valori di laboratorio in base ai test di laboratorio di sicurezza eseguiti in occasione della Visita POC del Giorno 85: aspartato aminotransferasi (AST), alanina aminotransferasi (ALT), o fosfatasi alcalina =2 × limite superiore della norma (ULN); o bilirubina =1,5 × ULN (bilirubina isolata superiore a 1,5 × ULN è accettabile se la bilirubina è frazionata e la bilirubina diretta è <35% o se vi è diagnosi precedente di malattia di Gilbert senza alcuna condizione che causi l'aumento della bilirubina).
    14. Aver presentato CK elevato >=2 × ULN in base ai test di laboratorio di sicurezza effettuati alla visita POC del Giorno 85. Nota: se il valore CK è >=2 × ULN alla visita POC del Giorno 85, il valore dalla visita POC del Giorno 113 può essere utilizzato per valutare l'eleggibilità. Se il valore dalla visita POC del Giorno 113 è ancora >=2 × ULN, ma < 5 x ULN, e secondo il parere dello sperimentatore il paziente non ha alcuna malattia correlata alla CK e il livello di CK si ritenga essere il risultato di fattori non patologici, è possibile ripetere il test di CK una volta entro 28 giorni e se stabile o migliorato, il paziente potrà essere arruolato.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability of M281 will be evaluated in terms of the Incidence and severity of adverse events (AEs; including serious AEs [SAEs], and AEs of special interest [AESIs]), vital signs, physical examinations, clinical laboratory testing (including chemistry,
    hematology, coagulation, and urinalysis), electrocardiograms (ECGs), and the Columbia-Suicide Severity Rating Scale (C-SSRS)
    Sicurezza e tollerabilità di M281 sarà valutata in termini di incidenza e gravità degli eventi avversi (AE, inclusi AE seri [SAE] ed AE di particolare interesse [AESI]), funzioni vitali, esami obiettivi, test clinici di laboratorio (tra cui analisi chimiche, ematologiche, della coagulazione e analisi delle urine), elettrocardiogrammi (ECG) e Scala di Valutazione del Rischio di Suicidio - Columbia (C-SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs are monitored throughout the study Vital signs will be measured immediately prior to the start of each infusion and 30 minutes after the first infusion and second infusions only. Full physical examinations to be performed at study enrollment and end of treatment/early termination, and a focused physical examination at all other site visits clinical laboratory testing (including chemistry, hematology, coagulation, and urinalysis) will be done on day 1, week 2,4,8,12 and every 12 weeks thereafter ECG will be taken immediately prior to the beginning of the infusion and right after the end of the infusion C-SSRS will be administered at the enrollment and then on week 2,4,8,12 and every 12 weeks thereafter.
    Gli AE sono monitorati per tutto il corso dello studio.
    Le funzioni vitali saranno misurate immediatamente prima dell'inizio di ciascuna infusione e solo 30 minuti dopo la prima e la seconda infusione.
    Esami obiettivi completi da eseguire all'arruolamento nello studio e alla fine del trattamento/interruzione anticipata e un esame obiettivo mirato in occasione di tutte le altre visite presso il centro
    E.5.2Secondary end point(s)
    1. Change from baseline in the total Myasthenia Gravis – Activities of Daily Living (MG-ADL) score over time
    2. Number of patients with a 2-, 3-, 4-, 5-, 6-, 7-, or =8-point improvement in total MG-ADL score over time
    3. Change from baseline in total Quantitative Myasthenia Gravis (QMG) score over time
    4. Change from baseline in total Revised Myasthenia Gravis Quality of Life – 15 Scale (MG-QoL15r) score over time
    5. Change from baseline in Clinical Global Impression of Severity (CGI-S)over time and Clinical Global Impression of Improvement (CGI-I) ratings
    6. Change from baseline in Myasthenia Gravis Foundation of America (MGFA) classification over time
    7. Incidence of anti-drug antibody (ADA) and neutralizing ADA (nADA) seroconversion over time
    8. Total serum immunoglobulin (Ig)G concentrations over time and change from baseline
    1. Variazione rispetto alla baseline nel punteggio totale relativo alle attività della vita quotidiana - Miastenia grave (MG-ADL) nel corso del tempo
    2. Numero di pazienti con un miglioramento di 2, 3, 4, 5, 6, 7 o =8 punti nel punteggio totale MG-ADL nel corso del tempo
    3. Variazione rispetto alla baseline nel punteggio quantitativo totale della miastenia grave (QMG) nel corso del tempo
    4. Variazione rispetto alla baseline nel punteggio totale relativo alla scala 15 rivista sulla qualità della vita - miastenia grave (MG-QoL15r) nel corso del tempo
    5. Variazione rispetto alla baseline nelle classificazioni dell’impressione clinica globale di gravità (CGI-S) nel corso del tempo e valutazioni dell'impressione clinica globale di cambiamento (CGI-C)
    6. Variazione rispetto alla baseline nella classificazione secondo la Fondazione Americana della Miastenia Grave (MGFA [Myasthenia Gravis Foundation of America]) nel corso del tempo
    7. Incidenza della sieroconversione dell’anticorpo anti-farmaco (ADA) e dell’ADA neutralizzante (nADA) nel corso del tempo
    8. Concentrazioni totali delle immunoglobuline (Ig)G nel siero nel corso del tempo e variazione rispetto alla baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. week 4 and 8, week 12 and every 12 weeks thereafter, EoT visit and on follow- up visit
    2. week 4 and 8, week 12 and every 12 weeks thereafter, EoT visit and on follow- up visit
    3. week 4 and 8, week 12 and every 12 weeks thereafter, EoT visit and follow -up visit
    4. week 4 and 8, week 12 and every 12 weeks thereafter, EoT visit and on follow up visit
    5. baseline, week 4 and 8, week 12 and every 12 weeks thereafter, EoT visit and on follow up visit
    6. baseline, week 8, and every 24 weeks thereafter and EoT visit
    7. week 4 and 8, week 12 and every 12 weeks thereafter, EoT visit and on follow up visit
    8. week 2, 4, 8, 12 and every 12 weeks thereafter, EoT visit and on follow up visit
    1. settimana 4 e 8, settimana 12 e successivamente ogni 12 settimane, visita EoT e alla visita di follow-up
    2. settimana 4 e 8, settimana 12 e successivamente ogni 12 settimane, visita EoT e alla visita di follow-up
    3. settimana 4 e 8, settimana 12 e successivamente ogni 12 settimane, visita EoT e visita di follow-up
    4. settimana 4 e 8, settimana 12 e successivamente ogni 12 settimane, visita EoT e alla visita di follow-up
    5. settimana 4 e 8, settimana 12 e successivamente ogni 12 settimane, visita EoT e alla visita di follow-up
    6. baseline, settimana 8, e successivamente ogni 24 settimane e visita EoT
    7. settimana 4 e 8, settimana 12 e successivamente ogni 12 settimane, visita EoT e alla visita di follow-up
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability, immunogenicity and biomarkers
    Tollerabilità, Immunogenicità e Biomarcatori
    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 Yes
    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) Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    United States
    Belgium
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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
    LPLV
    Il 09 dicembre 2020 lo Sponsor ha preso la decisione di non ricominciare lo studio MOM-M281-005 e di procedere con la chiusura dello studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days4
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 24
    F.4.2.2In the whole clinical trial 54
    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)
    Patients will continue their treatment per physician's discretion.
    Il paziente continuerà il trattamento a discrezione del 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 Decision2019-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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