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    Summary
    EudraCT Number:2021-000249-42
    Sponsor's Protocol Code Number:IMVT-1401-3101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-09-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-000249-42
    A.3Full title of the trial
    A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
    Studio di fase 3, multicentrico, randomizzato, in quadruplo cieco, controllato con placebo, per valutare l’efficacia e la sicurezza di Batoclimab come terapia di induzione e di mantenimento in partecipanti adulti affetti da miastenia grave generalizzata (gMG).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study to Assess Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with gMG
    Studio di fase 3 per valutare l’efficacia e la sicurezza di Batoclimab come terapia di induzione e di mantenimento in partecipanti adulti affetti da miastenia grave generalizzata (gMG).
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberIMVT-1401-3101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05403541
    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 SponsorImmunovant Sciences GmbH
    B.1.3.4CountrySwitzerland
    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 supportImmunovant Sciences GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunovant Sciences GmbH
    B.5.2Functional name of contact pointCentral Study Contact
    B.5.3 Address:
    B.5.3.1Street AddressViaduktstrasse 8
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4051
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0018007970414
    B.5.6E-mailclinicaltrials@immunovant.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/22/2684
    D.3 Description of the IMP
    D.3.1Product nameBatoclimab
    D.3.2Product code [IMVT-1401]
    D.3.4Pharmaceutical form Solution for injection 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 INNBatoclimab
    D.3.9.1CAS number 2187430-05-1
    D.3.9.2Current sponsor codeIMVT-1401
    D.3.9.3Other descriptive nameRVT-1401, HL161BKN, HBM9161
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number155 to 185
    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 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.IMP: 2
    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 numberEU/3/22/2684
    D.3 Description of the IMP
    D.3.1Product nameBatoclimab
    D.3.2Product code [IMVT-1401]
    D.3.4Pharmaceutical form Solution for injection 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 INNBatoclimab
    D.3.9.1CAS number 2187430-05-1
    D.3.9.2Current sponsor codeIMVT-1401
    D.3.9.3Other descriptive nameRVT-1401, HL161BKN, HBM9161
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number155 to 185
    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 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
    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
    Generalized Myasthenia Gravis (gMG)
    Miastenia grave generalizzata (gMG)
    E.1.1.1Medical condition in easily understood language
    Generalized Myasthenia Gravis (gMG)
    Miastenia grave generalizzata (gMG)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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 efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to PBO as Induction Therapy in AChRAb+ participants as assessed by change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.
    Valutare l’efficacia di batoclimab 680 mg SC QW o 340 mg SC QW rispetto a PBO come terapia di induzione nei partecipanti AChRAb+, in base alla variazione nel punteggio delle attività della vita quotidiana nella miastenia gravis (MG-ADL).
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to PBO as Induction Therapy in AChRAb+ participants as assessed by change in Quantitative Myasthenia Gravis (QMG) score.

    To evaluate the efficacy of batoclimab 340 mg SC QW or 340 mg SC once every 2 weeks (Q2W) compared to PBO as Maintenance Therapy in AChRAb+ participants who responded to Induction Therapy with batoclimab as assessed by changes in the MG-ADL score.

    To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to PBO as Induction Therapy in AChRAb+ participants for achieving improvement (decrease in score) in QMG score.

    Please refer to protocol section 2.4 for more secondary objectives.
    Valutare efficacia di batoclimab 680 mg SCQW o340 mgSCQW rispetto a PBO come terapia di induzione in partecipanti AChRAb+, in base a variazione nel punteggio quantitativo della miastenia grave(QMG).

    Valutare efficacia di batoclimab 340 mg SCQWo 340 mg SC una volta ogni 2 settimane(Q2W) rispetto a PBO come terapia di mantenimento nei partecipanti AChRAb+che hanno risposto alla terapia di induzione con batoclimab, in base a variazioni nel punteggio MG-ADL.

    Valutare efficacia di batoclimab 680mg SCQWo340mgSCQW rispetto aPBO come terapia di induzione nei partecipanti AChRAb+ per il raggiungimento di un miglioramento (diminuzione del punteggio) nel punteggio QMG.

    Si prega di fare riferimento al protocollo sezione 2.4 per tutti gli obiettivi secondari
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are >= 18 years of age at the Screening Visit.
    2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
    3. Have a QMG score >= 11 at the Screening and Baseline Visits.
    4. Have a MG-ADL score of >= 5 at the Screening and Baseline Visits.
    5. Additional inclusion criteria are defined in the protocol.
    1. Età >= 18 anni alla visita di screening.
    2. Avere gMG da lieve a grave in base alla classificazione Myasthenia Gravis Foundation of America (MGFA) Classe II, III o IVa alla visita di screening.
    3. Avere un punteggio QMG >= 11 alle visite di screening e di base.
    4. Avere un punteggio MG-ADL di >= 5 alle visite di screening e di base.
    5. Ulteriori criteri di inclusione sono definiti nel protocollo.
    E.4Principal exclusion criteria
    1. Have experienced myasthenic crisis within 3 months of the Screening Visit.
    2. Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
    3. Have any active or untreated malignant thymoma.
    4. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year.
    5. Have used anti-FcRN treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRN treatment.
    6. Additional exclusion criteria are defined in the protocol.
    1. Aver sperimentato una crisi miastenica entro 3 mesi dalla visita di screening.
    2. Aver avuto una timectomia eseguita < 6 mesi prima della visita di screening o aver avuto una timectomia pianificata durante il periodo di studio.
    3. Avere un timoma maligno attivo o non trattato.
    4. Aver ricevuto qualsiasi agente o terapia (esclusi quelli identificati all'interno dei criteri di inclusione) con proprietà immunosoppressive (ad esempio, terapia con cellule staminali, chemioterapie, ecc.) nell'ultimo anno.
    5. Aver usato il trattamento anti-FcRN entro 3 mesi prima della visita di screening o hanno una storia documentata di non risposta a un precedente trattamento anti-FcRN.
    6. Ulteriori criteri di esclusione sono definiti nel protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12)
    Variazione dal basale del Periodo 1 nel punteggio MG-ADL alla Settimana 12 per i partecipanti AChRAb+ (intervallo temporale: dal basale del Periodo 1 alla Settimana 12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    per protocol
    Come da protocollo
    E.5.2Secondary end point(s)
    Change from Period 1 baseline in QMG score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12)

    Change from Period 2 baseline in MG-ADL score to Week 24 for AChRAb+ randomized withdrawal participants (Timeframe: Week 12 to Week 24)

    Proportion of AChRAb+ participants with >= 3-point improvement (decrease in score) in QMG from Period 1 baseline to Week 12 (Timeframe: Period 1 baseline to Week 12)

    Proportion of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12 (Timeframe: Period 1 baseline to Week 12)

    Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb- participants (Timeframe: Period 1 baseline to Week 12)
    Variazione dal basale del Periodo 1 nel punteggio QMG alla Settimana 12 per i partecipanti AChRAb+ (intervallo temporale: dal basale del Periodo 1 alla Settimana 12).

    Variazione dal basale del Periodo 2 nel punteggio MG-ADL alla Settimana 24 per i partecipanti AChRAb+ con ritiro randomizzato (intervallo temporale: dalla Settimana 12 alla Settimana 24)

    Percentuale di partecipanti AChRAb+ con miglioramento >=3 punti (diminuzione del punteggio) nella QMG dal basale del Periodo 1 alla Settimana 12 (intervallo temporale: dal basale del Periodo 1 alla Settimana 12)

    Percentuale di partecipanti AChRAb+ che raggiungono un punteggio MG-ADL di 0 o 1 entro la Settimana 12 (intervallo temporale: dal basale del Periodo 1 alla Settimana 12)

    Variazione dal basale del Periodo 1 nel punteggio MG-ADL alla Settimana 12 per i partecipanti AChRAb- (intervallo temporale: dal basale del Periodo 1 alla Settimana 12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    per protocol
    Come da protocollo
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Estensione a lungo termine (LTE)
    Long-term Extension (LTE)
    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 trial9
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Argentina
    Australia
    Brazil
    Canada
    Japan
    Korea, Republic of
    Mexico
    United States
    France
    Poland
    Romania
    Spain
    Czechia
    Germany
    Italy
    Georgia
    Hungary
    United Kingdom
    Serbia
    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
    The end of study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in Section 1.3 of the protocol for the last participant in the study.
    La fine dello studio è definita come la data dell'ultima visita dell'ultimo partecipante allo studio o dell'ultima procedura programmata mostrata nella sezione 1.3 del protocollo per l'ultimo partecipante allo studio.
    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 years2
    E.8.9.2In all countries concerned by the trial months10
    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 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: 189
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 210
    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)
    Options for continuation of treatment beyond the current protocol will
    be evaluated upon completion of primary analysis.
    Le opzioni per la continuazione del trattamento oltre l'attuale protocollo saranno valutate al completamento dell'analisi primaria.
    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 Decision2022-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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