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    Summary
    EudraCT Number:2022-002787-68
    Sponsor's Protocol Code Number:IMVT-1401-3201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-01-04
    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 number2022-002787-68
    A.3Full title of the trial
    A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
    Studio controllato con placebo di fase 3, multicentrico, randomizzato, in quadruplo cieco di batoclimab per il trattamento di partecipanti affetti da oftalmopatia tiroidea (TED) attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study to Assess Batoclimab in Participants with Active Thyroid Eye Disease
    Studio di fase 3 per testare Batoclimab in partecipanti affetti da oftalmopatia tiroidea (TED) attiva
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberIMVT-1401-3201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05517421
    A.5.4Other Identifiers
    Name:INDNumber:141988
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/452/2022
    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 number18007970414
    B.5.5Fax number0000000
    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 No
    D.2.5.1Orphan drug designation number
    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
    Thyroid Eye Disease (TED)
    Oftalmopatia tiroidea (TED) attiva
    E.1.1.1Medical condition in easily understood language
    Thyroid Eye Disease (TED)
    Oftalmopatia tiroidea (TED) attiva
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of batoclimab 680 mg subcutaneously (SC) once a week (QW) for 12 weeks followed by 340 mg SC QW for 12 weeks versus placebo on proptosis responder rate at Week 24
    Valutare l'efficacia di batoclimab 680 mg per via sottocutanea (SC) una volta alla settimana (QW) per 12 settimane seguita da 340 mg di SC QW per 12 settimane rispetto al placebo sul tasso di risposta alla proptosi alla settimana 24
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis and Clinical Activity Score (CAS)
    • To evaluate the efficacy of batoclimab compared to placebo as assessed by CAS
    • To evaluate the efficacy of batoclimab compared to placebo assessed by change in binding anti-TSHR antibodies (Abs)
    • To evaluate the efficacy of batoclimab compared to placebo as assessed by Gorman score for diplopia
    • To evaluate the efficacy of batoclimab compared to placebo as assessed by proptosis
    • To evaluate the efficacy of batoclimab compared to placebo as assessed by Graves’ ophthalmology-specific quality of life (GO-QOL)
    • To evaluate the efficacy of batoclimab compared to placebo as assessed by motility
    • Valutare l'efficacia di batoclimab rispetto al placebo valutata mediante proptosi e punteggio di attività clinica (CAS)
    • Valutare l'efficacia di batoclimab rispetto al placebo come valutato dal CAS
    • Valutare l'efficacia di batoclimab rispetto al placebo valutata in base alla variazione degli anticorpi anti-TSHR leganti (Abs)
    • Valutare l'efficacia di batoclimab rispetto al placebo come valutato dal punteggio Gorman per diplopia
    • Valutare l'efficacia di batoclimab rispetto al placebo come valutato mediante proptosi
    • Valutare l'efficacia di batoclimab rispetto al placebo come valutato dalla qualità della vita specifica per oftalmologia di Graves (GO-QOL)
    • Valutare l'efficacia di batoclimab rispetto al placebo valutata dalla motilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are =18 years of age at screening.

    2. Have a clinical diagnosis of TED associated with active, moderate to severe TED with a CAS =4 in either eye at screening and Baseline.

    3. Have moderate to severe active TED, as defined by European Group on Graves' Orbitopathy (EUGOGO) guidelines.

    4. Have onset of active TED within 12 months prior to screening.

    5. Have documented evidence of detectable anti-TSHR-Ab at screening.

    6. Are not expected to require immediate surgical intervention and are not planning corrective surgery/irradiation or medical therapy for TED during the course of the study.

    7. Are euthyroid with the baseline disease under control or have mild hypo- or hyperthyroidism.

    Additional inclusion criteria are defined in the protocol.
    1. Avere =18 anni di età allo screening.
    2. Avere una diagnosi clinica di TED associata a TED attiva, da moderata a
    TED grave con un CAS =4 in entrambi gli occhi allo screening e al basale.
    3. Avere TED attiva da moderata a grave, come definito dal Gruppo europeo
    Linee guida per l'orbitopatia di Graves (EUGOGO).
    4. Avere l'insorgenza di TED attiva entro 12 mesi dallo screening.
    5. Avere prove documentate di anticorpi anti-TSHR rilevabili allo screening.
    6. Non è prevista la necessità di un intervento chirurgico immediato e non è stato programmato un intervento chirurgico/una radioterapia correttiva o terapia medica per TED durante il corso dello studio.
    7. Essere eutiroidei con la malattia basale sotto controllo o lieve ipo- o ipertiroidismo.

    Ulteriori criteri di inclusione sono definiti nel protocollo.
    E.4Principal exclusion criteria
    1. Have decreased best corrected visual acuity due to optic neuropathy.

    2. Have at least a 2-point decrease in CAS or =2 mm decrease in proptosis between screening and Baseline assessments in either eye.

    3. Have used any steroid (intravenous or oral) for the treatment of TED or other conditions within 4 weeks prior to screening.

    4. Have used any steroid (Intravenous or oral) with a cumulative dose equivalent to = 1 g of methylprednisolone for the treatment of TED.

    5. Have known autoimmune disease other than TED, that, in the opinion of the Investigator, would interfere with the course and conduct of the study.

    6. Had previous orbital irradiation or surgery for TED.

    Additional exclusion criteria are defined in the protocol.
    1. Riduzione della migliore acuità visiva corretta a causa della neuropatia ottica.

    2. Diminuzione di almeno 2 punti nel punteggio CAS o = 2 mm di diminuzione della proptosi tra lo screening e le valutazioni basali in entrambi gli occhi.

    3. Uso di steroidi (endovenosi o orali) per il trattamento di TED o altre condizioni entro 4 settimane prima dello screening.

    4. Uso di qualsiasi steroide (endovenoso o orale) con una dose cumulativa equivalente a = 1 g di metilprednisolone per il trattamento di TED.

    5. Presentare malattie autoimmuni diverse da TED, che, secondo il parere dello sperimentatore, interferirebbero con il corso e la conduzione dello studio.

    6. Essere stato sottoposto a precedenti irradiazioni orbitali o interventi chirurgici per TED.

    Ulteriori criteri di esclusione sono definiti nel protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of proptosis responders (proptosis responder rate) at Week 24 where proptosis responder is defined as the participant with a = 2 mm reduction in the study eye without deterioration (= 2 mm increase) in the fellow eye
    Percentuale di responder alla proptosi (tasso di responder alla proptosi) alla Settimana 24, dove responder alla proptosi è definito come il partecipante con una riduzione =2 mm nell’occhio oggetto di studio senza peggioramento (aumento =2 mm) nell’occhio controlaterale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    settimana 24
    E.5.2Secondary end point(s)
    • Proportion of participants with proptosis = 2 mm reduction and CAS of = 3 at Week 24 from baseline in the study eye
    • Proportion of participants with CAS of 0 or 1 at Week 24 in the study eye
    • Mean change from baseline to Week 24 in CAS in the study eye
    • Proportion of participants with positive binding anti-TSHR Ab at baseline who achieve seroconversion at Week 24
    • Proportion of participants with decrease of at least 1 grade from baseline in Gorman score for diplopia at Week 24 in participants who have diplopia at baseline.
    • Mean change from baseline to Week 24 in proptosis (mm) in the study eye
    • Proportion of participants with = 6-point increase from baseline in total GO-QOL score at Week 24 in participants who have the ability to increase by = 6-points from baseline
    • Proportion of participants with = 8-degree increase from baseline in motility (in at least 1 of 4 directions) at Week 24 in the study eye in participants who have the ability to increase by = 8 degrees from baseline.
    • Percentuale di partecipanti con riduzione della proptosi =2 mm e punteggio CAS= 3 alla Settimana 24 rispetto al basale nell’occhio oggetto di studio
    • Percentuale di partecipanti con punteggio CAS di 0 o 1 alla Settimana 24 nell’occhio oggetto di studio
    • Variazione media dal basale alla Settimana 24 nel punteggio CAS nell’occhio oggetto di studio
    • Percentuale di partecipanti con Ab anti-TSHR leganti positivi al basale che raggiungono la sieroconversione alla Settimana 24
    • Percentuale di partecipanti con riduzione di almeno 1 grado rispetto al basale nel punteggio di Gorman per la diplopia alla Settimana 24 nei partecipanti che presentano diplopia al basale.
    • Variazione media dal basale alla Settimana 24 nella proptosi (mm) nell’occhio oggetto di studio
    • Percentuale di partecipanti con aumento =6 punti rispetto al basale nel punteggio GO-QOL totale alla Settimana 24 nei partecipanti che hanno la capacità di aumentare di =6 punti rispetto al basale
    • Percentuale di partecipanti con aumento =8 gradi rispetto al basale della motilità (in almeno 1 di 4 direzioni) alla Settimana 24 nell’occhio oggetto di studio nei partecipanti che hanno la capacità di aumentare di =8 gradi rispetto al basale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    settimana 24
    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 No
    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
    healthcare economic outcome measures
    Misure di esito economico sanitario
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    Japan
    United States
    France
    Poland
    Sweden
    Netherlands
    Germany
    Italy
    Denmark
    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
    The end of study is defined as the date of the last visit of the last participant in the study.
    La fine dello studio è definita come la data dell'ultima visita dell'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 months3
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days11
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 100
    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)
    Participants will have the option to enroll in study IMVT-1401-3203.
    I partecipanti avranno la possibilità di essere arruolati nello studio IMVT-1401-3203.
    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 Decision2023-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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