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    Summary
    EudraCT Number:2021-005000-36
    Sponsor's Protocol Code Number:VGN-TED-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-23
    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 ConcernedSpain - AEMPS
    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)
    Un estudio de fase IIb, aleatorizado, con enmascaramiento doble y controlado con placebo para evaluar la seguridad, farmacocinética y eficacia del linsitinib en pacientes con enfermedad ocular tiroidea (EOT) activa y de moderada 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
    Estudio para evaluar la seguridad y eficacia del linsitinib en pacientes con enfermedad ocular tiroidea (EOT) activa y de moderada a grave.
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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)
    Enfermedad Ocular Tiroidea (EOT)
    E.1.1.1Medical condition in easily understood language
    Thyroid eye disease
    Enfermedad Ocular Tiroidea
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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 20.0
    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 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.
    El objetivo principal es estudiar el efecto de dos dosis del linsitinib frente al placebo sobre la tasa de respuesta en la proptosis en la semana 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.Evaluar el efecto del linsitinib frente al placebo sobre el cambio medio desde el inicio hasta la semana 24 en la medición de la proptosis en el ojo principal del estudio.
    2.Evaluar el efecto del linsitinib frente al placebo en la tasa de respuesta de la diplopía en la semana 24.
    3.Evaluar el efecto del linsitinib frente al placebo en la tasa de respuesta global en la escala CAS o proptosis en el ojo contralateral no evaluado en el estudio en la semana 24.
    4.Evaluar el efecto del linsitinib frente al placebo en el porcentaje de pacientes con un valor CAS de 0 o 1 en la semana 24 en el ojo principal del estudio.
    5.Evaluar el efecto del linsitinib frente al placebo en el cambio medio desde el inicio hasta la semana 24 en la puntuación general del Cuestionario de calidad de vida en oftalmopatía de Graves (GO-QoL, Graves’ Ophthalmopathy Quality of Life).
    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.Los pacientes deben ser mayores de 18 años de edad.
    2.Diagnóstico clínico de enfermedad de Graves y/o tiroiditis autoinmunitaria de Hashimoto asociada con EOT activa de moderada a grave con una puntuación CAS ≥ 4 para el ojo más afectado en la selección y al inicio.
    3.EOT activa de moderada a grave en los 12 meses anteriores a la visita inicial y generalmente asociada a una o más de las criterios descritos en el protocolo.
    4.Los pacientes deben ser eutiroideos o tener hipertiroidismo subclínico.
    5.No requiere cirugía, radioterapia u otra intervención oftalmológica inmediata en el momento de la selección y no está planificando ningún tratamiento de este tipo durante el transcurso del estudio.
    6.Los pacientes diabéticos deben tener unos valores de HbA1c < 9,0 %.

    Por favor vea los detalles completos en el protocolo.
    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.Disminución de la mejor agudeza visual corregida debido a neuropatía óptica definida por una disminución de la visión de 2 líneas en la tabla de Snellen, un nuevo defecto del campo visual o un defecto de color secundario a una afectación del nervio óptico en los últimos 6 meses.
    2.Descompensación corneal que no responde al tratamiento médico.
    3.Reducción de la puntuación de CAS de ≥ 2 puntos en el ojo principal del estudio entre la selección y el inicio.
    4.Reducción de la proptosis ≥ 2 mm en el ojo principal del estudio entre la selección y el inicio.
    5.Irradiación o cirugía orbitaria previa.
    6.Tratamiento previo con inhibidores de IGF-1R para cualquier afección.
    7.Uso de cualquier tipo de esteroide (intravenoso [i.v.] u oral) con una dosis acumulativa equivalente a > 1 g de metilprednisolona o equivalente para el tratamiento de la EOT en los 3 meses previos a la selección.
    8.Uso de corticosteroides (incluidos los tópicos) para afecciones distintas de la EOT en las 4 semanas previas a la selección (se permiten los esteroides inhalados).
    9.Uso de cualquier otro agente inmunosupresor no esteroide en las 4 semanas previas a la selección.
    10.Cualquier tratamiento previo con anticuerpos contra el receptor de la IL6, contra el CD20, (MS4A1) o anticuerpos monoclonales para la inmunomodulación en los últimos 9 meses antes de la selección.
    11.El uso de selenio y/o biotina como tratamiento para la EOT en las 3 semanas previas a la selección es descalificante, no está permitido y no debe reiniciarse durante el ensayo clínico o el periodo de seguimiento.
    12.Enfermedad oftálmica u otra enfermedad preexistente identificada que, a juicio del investigador, impediría la participación en el estudio o complicaría la interpretación de los resultados del estudio.
    13.Cirugía ocular que no sea cirugía de cataratas de rutina o capsulotomía con láser YAG posterior.
    14.Enfermedad inflamatoria intestinal diagnosticada por biopsia o sospecha clínica de ella (p. ej., diarrea con o sin sangre o sangrado rectal asociado con dolor abdominal o calambres/cólicos, tenesmo vesical, tenesmo o incontinencia durante más de 4 semanas sin un diagnóstico alternativo confirmado O evidencia endoscópica o radiológica de enteritis/colitis sin un diagnóstico alternativo confirmado).
    15.Antecedentes de prolongación del intervalo QTcF; o prolongación del intervalo QTcF en la selección.
    16.Uso de fármacos que prolongan el intervalo QT en los 14 días anteriores a la administración del día 1.
    17.Diátesis hemorrágica que a juicio del Investigador excluiría la inclusión en el ensayo clínico.
    18.Valores de laboratorio como se describen en el protocolo.
    19.Enfermedad maligna que se está tratado de forma activa o que se ha tratado en los últimos 12 meses (con la excepción del carcinoma basocelular cutáneo tratado con éxito). Se excluye el carcinoma basocelular de párpado reciente (en los 3 meses previos a la selección).

    Ver la lista completa en el protocolo.
    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.
    Tasa de efecto de linsitinib frente a placebo en la tasa de respuesta a la proptosis en la semana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24.
    A la semana 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.Cambio medio desde el inicio hasta la semana 24 en la medición de la proptosis en el ojo principal del estudio.
    2.Tasa de respuesta de la diplopía
    3.Tasa de respuesta global
    4.Porcentaje de pacientes con un valor CAS de 0 o 1 en la semana 24 en el ojo principal del estudio.
    5.Cambio medio desde el inicio hasta la semana 24 en la puntuación general del Cuestionario de calidad de vida en oftalmopatía de Graves (GO-QoL).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 24
    A la semana 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
    QOL
    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 No
    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
    Germany
    Italy
    United Kingdom
    Spain
    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
    Última Visita del Último Paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 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 state9
    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.
    Al final del período de tratamiento de enmascaramiento doble(semana 24), los sujetos que no respondan a la proptosis (el ojo principal del estudio tiene una disminución de <2mm) serán aptos para participar en un estudio de extensión(VGN-TED-302)
    Si los sujetos cumplen con los criterios de respuesta en la semana 24 pero luego experimentan una recaída de la enfermedad durante el período de seguimiento de 48 semanas, tendrán la opción de ingresar al estudio de extensión
    Ver protocolo, sección 2.3
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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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
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