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    Summary
    EudraCT Number:2021-005000-36
    Sponsor's Protocol Code Number:VGN-TED-301
    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:2022-08-25
    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 number2021-005000-36
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-Mask, Placebo-Controlled, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Linsitinib in Subjects with Active, Moderate to Severe Thyroid Eye Disease (TED)
    Studio di fase 2b randomizzato, doppio cieco, controllato con placebo, mirato a valutare la sicurezza, la farmacocinetica e l'efficacia di linsitinib in soggetti affetti da malattia dell'occhio tiroideo (TED) attiva da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of Linsitinib in Patients with Active, Moderate to Severe Thyroid Eye Disease
    Studio per valutare la sicurezza e l'efficacia di Linsitinib nei pazienti con Malattia dell'occhio tiroideo attiva, da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    LIDS
    LIDS
    A.4.1Sponsor's protocol code numberVGN-TED-301
    A.5.4Other Identifiers
    Name:INDNumber:157686
    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 SponsorVasaraGen, 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 supportVasaraGen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVasaraGen, Inc.
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street Address455 E. Eisenhower Pkwy, Suite 300
    B.5.3.2Town/ cityAnn Arbor
    B.5.3.3Post codeMI 48105
    B.5.3.4CountryUnited States
    B.5.6E-mailinfo@vasaragen.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 nameLinsitinib
    D.3.2Product code [ASP7487, OSI-906]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinsitinib
    D.3.9.1CAS number 867160-71-2
    D.3.9.2Current sponsor codeASP7487, OSI-906
    D.3.9.3Other descriptive nameLINSITINIB
    D.3.9.4EV Substance CodeSUB35196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLinsitinib
    D.3.2Product code [ASP7487, OSI-906]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLinsitinib
    D.3.9.1CAS number 867160-71-2
    D.3.9.2Current sponsor codeASP7487, OSI-906
    D.3.9.3Other descriptive nameLINSITINIB
    D.3.9.4EV Substance CodeSUB35196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral 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)
    Malattia dell'occhio tiroideo (TED)
    E.1.1.1Medical condition in easily understood language
    Thyroid eye disease
    Malattia dell'occhio tiroideo (TED)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10060742
    E.1.2Term Endocrine ophthalmopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10072802
    E.1.2Term Thyroid associated orbitopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10057889
    E.1.2Term Graves' ophthalmopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to study the effect of two doses of linsitinib versus placebo on the proptosis responder rate at Week 24.
    L'obiettivo principale è studiare l'effetto di due dosi di linsitinib rispetto al placebo sul tasso di risposta alla proptosi alla settimana 24.
    E.2.2Secondary objectives of the trial
    1. Evaluate the effect of linsitinib versus placebo on the mean change from Baseline to Week 24 in proptosis measurement in the primary study eye.
    2. Evaluate the effect of linsitinib versus placebo on the diplopia responder rate at Week 24.
    3. Evaluate the effect of linsitinib versus placebo on the overall responder rate in CAS or proptosis in the contralateral non-study eye at Week 24.
    4. Evaluate the effect of linsitinib versus placebo on the percentage of subjects with a CAS value of 0 or 1 at Week 24 in the primary study eye.
    5. Evaluate the effect of linsitinib versus placebo on the mean change from Baseline to Week 24 in the Graves’ Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score.
    1. Valutare l'effetto di linsitinib rispetto al placebo sulla variazione media dal basale alla settimana 24 nella misurazione della proptosi nell'occhio primario di studio.
    2. Valutare l'effetto di linsitinib rispetto al placebo sul tasso di risposta alla diplopia alla settimana 24.
    3. Valutare l'effetto di linsitinib rispetto al placebo sul tasso di risposta globale in CAS o proptosi nell'occhio controlaterale non in studio alla Settimana 24.
    4. Valutare l'effetto di linsitinib rispetto al placebo sulla percentuale di soggetti con un valore CAS di 0 o 1 alla settimana 24 nell'occhio primario di studio.
    5. Valutare l'effetto di linsitinib rispetto al placebo sulla variazione media dal basale alla settimana 24 nel punteggio complessivo del questionario sulla qualità della vita (GO-QoL) dell'oftalmopatia di Graves.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be =18 years of age at Screening.
    2. Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS = 4 for the most severely affected eye at Screening and Baseline.
    3. Moderate-to-severe active TED with onset within 12 months prior to the Baseline visit and usually associated with one or more of the criteria described in the protocol.
    4. Subjects must be euthyroid or, have subclinical hyperthyroidism.
    5. Does not require immediate surgery, radiotherapy or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.
    6. Diabetic subjects must have HbA1c < 9.0%.

    Please see the full details in the protocol.
    1. I soggetti devono avere compiuto =18 anni al momento dello Screening.
    2. Diagnosi clinica di oftalmopatia di Graves e/o tiroidite autoimmune di Hashimoto associata a TED attiva da moderata a grave con un punteggio CAS di = 4 per l'occhio colpito più gravemente allo Screening e al Basale.
    3. TED attiva da moderata a grave con esordio nei 12 mesi precedenti la Visita basale e di solito associata a una o più delle condizioni descritte nel protocollo.
    4. I soggetti devono essere eutiroidei o avere un ipertiroidismo subclinico.
    5. I soggetti non devono necessitare di intervento chirurgico immediato, radioterapia o altro intervento oftalmologico al momento dello Screening e non prevedere alcun trattamento di questo tipo nel corso dello studio.
    6. I soggetti diabetici devono avere HbA1c < 9,0%.

    Si prega di fare riferimento ai dettagli completi nel protocollo.
    E.4Principal exclusion criteria
    1. Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
    2. Corneal decompensation unresponsive to medical management.
    3. Decrease in CAS of = 2 points in the primary study eye between Screening and Baseline.
    4. Decrease in proptosis of = 2 mm in the primary study eye between Screening and Baseline.
    5. Previous orbital irradiation or surgery.
    6. Prior IGF-1R inhibitor therapy for any condition.
    7. Any steroid use (intravenous [IV] or oral) with a cumulative dose equivalent to > 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
    8. Corticosteroid use (including topical) for conditions other than TED within 4 weeks prior to Screening.
    9. Use of any other non-steroid immunosuppressive agent within 4 weeks prior to Screening.
    10. Any previous treatment with anti-IL6 receptor, anti- CD20, (MS4A1) antibodies or monoclonal antibody for immunomodulation within the past 9 months prior to Screening.
    11. Selenium and/or biotin use as a treatment for TED within 3 weeks prior to screening is disqualifying, not allowed and must not be restarted during the clinical trial or Follow-up period.
    12. Identified pre-existing ophthalmic or other disease that in the judgement of the Investigator, would preclude study participation or complicate interpretation of study results.
    13. Ocular surgery other than routine cataract surgery or subsequent YAG laser capsulotomy.
    14. Biopsy-proven or clinically suspected inflammatory bowel disease (e.g., diarrhea with or without blood or rectal bleeding associated with abdominal pain or cramping/colic, urgency, tenesmus, or incontinence for more than 4 weeks without a confirmed alternative diagnosis OR endoscopic or radiologic evidence of enteritis/colitis without a confirmed alternative diagnosis).
    15. History of QTcF prolongation; or QTcF prolongation at Screening.
    16. Use of drugs causing QT interval prolongation within 14 days prior to Day 1 dosing.
    17. Bleeding diathesis that in the judgment of the Investigator would preclude inclusion in the clinical trial.
    18. Laboratory values as described in the protocol.
    19. Malignant conditions being actively treated or treated in the past 12 months (with the exception of successfully treated basal cell of the skin). Recent (within 3 months of Screening) basal cell of the eyelid skin is excluded.

    See the full list in the protocol.
    1.Riduzione dell'acuità visiva corretta al meglio dovuta a neuropatia ottica consistente in una diminuzione della vista di 2 righe sulla tabella di Snellen, di un nuovo difetto del campo visivo o difetto cromatico secondario al coinvolgimento del nervo ottico negli ultimi 6 mesi. 2.Scompenso corneale che non risponde alla gestione medica. 3.Riduzione del punteggio CAS = 2 punti per l'occhio primario tra lo Screening e il Basale. 4.Riduzione della proptosi = 2 mm nell'occhio primario tra lo screening e il basale. 5.Precedente irradiazione orbitale o intervento chirurgico. 6.Terapia precedente con inibitori dell'IGF-1R per qualsiasi patologia. 7.Uso di qualunque steroide [per via e.v. o orale] con una dose cumulativa equivalente a > 1 g di metilpredniso-lone o equivalente per il trattamento della TED entro 3 mesi dallo Screening. (NOTA: l'uso precedente di colliri steroidei è consentito se interrotto almeno 4 sett. prima dello Screening.). 8.Uso di corticosteroidi (anche topico) per patologie diverse dalla TED nelle 4 sett. precedenti lo Screening (sono consentiti steroidi per via inalatoria). 9.Uso di qualsiasi altro agente immunosoppressivo non steroideo nelle 4 sett. precedenti lo Screening. 10.Qualsiasi precedente trattamento con anticorpi del recettore anti-IL6, anti-CD20, (MS4A1) o anticorpo monoclonale per l'immunomodulazione negli ultimi 9 mesi prima dello Screening. 11.L'utilizzo di selenio e/o biotina per il trattamento della TED nelle 3 sett. precedenti lo Screening rende il soggetto non idoneo, non è ammesso e non deve essere ripreso durante la sperimentazione o il follow-up. Eventuali multivitaminici contenenti selenio e/o biotina devono essere interrotti allo screening e non ripresi durante lo studio. 12.Assunzione di un farmaco sperimentale per qualsiasi patologia entro 30 gg. dallo Screening o sua assunzione prevista durante la sperimentazione. 13.I soggetti che arruolati in questo studio non potranno essere nuovamente randomizzati per lo stesso studio. Nota: prima dell'arruolamento i soggetti che non abbiano superato lo screening potranno, dopo aver consultato il Monitor medico, essere autorizzati a ripetere lo screening. 14.Eventuali malattie oftalmiche o altre malattie preesistenti identificate che, a giudizio dello Sperimentatore, possano precludere la partecipazione allo studio o complicare l'interpretazione del risultati dello studio [a titolo esemplificativo, ma non limitativo: precedente intervento chirurgico alle palpebre, malattia corneale (che non sia una cheratopatia causata dalla TED che non soddisfa altri criteri di esclusione), uveite, edema maculare diabetico, retinopatia diabetica, occlusione della vena retinica, degenerazione maculare, altra retinopatia, distacco della retina, glaucoma o patologia del nervo ottico oppure danni al nervo ottico). 15.Intervento agli occhi diverso dalla chirurgia di routine della cataratta o successiva capsulotomia a laser YAG (La chirurgia della cataratta e la capsulotomia a laser YAG sono consentite se le procedure chirurgiche sono state eseguite più di 3 mesi prima della randomizzazione). 16. Malattia infiammatoria intestinale comprovata da biopsia o clinicamente sospettata (es., diarrea con o senza sangue o emorragia rettale associata a dolore addominale o crampi/coliche, tenesmo vescicale, tenesmo o incontinenza per più di 4 sett. senza una diagnosi alternativa confermata OPPURE evidenza endoscopica o radiologica di enterite/colite senza una diagnosi alternativa confermata). 17.Pregresso prolungamento del QTcF o prolungamento del QTcF allo Screening; intervallo QTcF medio > 450 msec (maschi) e > 470 msec (femmine). 18.Uso di farmaci che causano il prolungamento dell'intervallo QT entro 14 gg. dalla somministrazione della dose al Giorno 1 (vedasi sez. 12.2 Elenco dei farmaci che prolungano l'intervallo QT). 19.Diatesi emorragica che, a giudizio dello Sperimentatore, precluderebbe l'inclusione nella sperimentazione.
    Si veda l'elenco completo nel protocollo
    E.5 End points
    E.5.1Primary end point(s)
    Rate of effect of linsitinib versus placebo on the proptosis responder rate at Week 24.
    Tasso di effetto di linsitinib rispetto al placebo sul tasso di risposta per la proptosi alla Settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24.
    Alla settimana 24.
    E.5.2Secondary end point(s)
    1. Mean change from Baseline to Week 24 in proptosis measurement in the primary study eye.
    2. Diplopia responder rate.
    3. Overall responder rate.
    4. Percentage of subjects with a CAS value of 0 or 1 at Week 24 in the primary study eye.
    5. Mean change from Baseline to Week 24 in the Graves' Ophthalmopathy Quality of Life (GO-QoL) questionnaire overall score.
    1. Variazione media dal Basale alla Settimana 24 nella misurazione della proptosi nell'occhio primario dello studio.
    2. Tasso di risposta alla diplopia.
    3. Tasso di risposta globale.
    4. Percentuale di soggetti con un valore CAS di 0 o 1 alla Settimana 24 per l'occhio primario dello studio.
    5. Variazione media dal Basale alla Settimana 24 del punteggio complessivo ottenuto al questionario sulla qualità della vita nei pazienti affetti da oftalmopatia di Graves (GO-QoL).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 24
    Alla 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 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
    QOL
    Qualità della vita
    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 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 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 trial3
    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 EEA14
    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
    Spain
    Germany
    Italy
    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
    LVLS
    LVLS
    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 months11
    E.8.9.2In all countries concerned by the trial days15
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 75
    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)
    At the end of the Double-mask Treatment Period (Week 24), subjects who are proptosis non-responders (primary study eye has < 2 mm decrease in proptosis) will be eligible to enter an extension study (VGN-TED-302).
    If subjects meet the response criteria at Week 24 but subsequently experience a disease relapse during the 48-week Follow-Up Period, they will have the option to enter the VGN-TED-302 Extension Study.
    Please refer to protocol section 2.3 for details.
    Alla fine del Trattamento in doppio cieco (Sett. 24), i soggetti che non rispondono alla proptosi (l'occhio primario di studio ha una diminuzione della proptosi < 2 mm) saranno idonei a partecipare a uno studio di estensione (VGN-TED-302). Se i soggetti soddisfano i criteri di risposta alla Sett. 24 ma poi sperimentano una ricaduta nel periodo di follow-up di 48 sett., potranno accedere allo studio di estensione. Si prega di fare riferimento alla sez. 2.3 del protocollo per i dettagli.
    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 Decision2022-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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