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    Summary
    EudraCT Number:2018-001606-29
    Sponsor's Protocol Code Number:INCB39110-309
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-04-09
    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 number2018-001606-29
    A.3Full title of the trial
    A Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
    GRAVITAS-309: Estudio en fase III de itacitinib o placebo en combinación con corticoesteroides como tratamiento inicial de la enfermedad de injerto contra huésped crónica (EICHc)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating safety and efficacy of Itacitinib or Placebo in combination with corticosteroids as initial treatment of chronic graft versus-host disease
    Estudio para evaluar la seguridad y eficacia itacitinib o Placebo en combinación con corticoesteroides como tratamiento inicial para la EICHc moderada o
    grave.
    A.3.2Name or abbreviated title of the trial where available
    GRAVITAS-309
    GRAVITAS-309
    A.4.1Sponsor's protocol code numberINCB39110-309
    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 SponsorIncyte Corporation
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.5Fax number13024252734
    B.5.6E-mailRA@incyte.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/3/17/1964
    D.3 Description of the IMP
    D.3.1Product nameItacitinib
    D.3.2Product code INCB039110
    D.3.4Pharmaceutical form Modified-release 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 INNITACITINIB ADIPATE
    D.3.9.1CAS number 1334302-63-4
    D.3.9.2Current sponsor codeINCB039110 ADIPATE
    D.3.9.3Other descriptive nameITACITINIB ADIPATE
    D.3.9.4EV Substance CodeSUB184194
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboTablet
    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
    Moderate or severe cGVHD
    EICHc moderada o grave.
    E.1.1.1Medical condition in easily understood language
    Moderate or severe chronic Graft Versus Host Disease
    Enfermedad de injerto contra huésped crónica grave o moderada
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10066261
    E.1.2Term Chronic graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10072160
    E.1.2Term Chronic graft versus host disease in liver
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10072158
    E.1.2Term Chronic graft versus host disease in intestine
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10072159
    E.1.2Term Chronic graft versus host disease in skin
    E.1.2System Organ Class 10021428 - Immune 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
    Part 1: To identify an appropriate dose of itacitinib in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
    Part 2: To compare the efficacy of itacitinib versus placebo in combination with corticosteroids as initial treatment for moderate or severe cGVHD.
    1. Identificar la dosis adecuada de itacitinib en combinación con corticoesteroides como tratamiento inicial para la EICHc moderada o grave.
    2. Comparar la eficacia entre itacitinib y placebo en combinación con corticoesteroides como tratamiento inicial para la EICHc de moderada a grave.
    E.2.2Secondary objectives of the trial
    Part 1:
    - To evaluate the PK of itacitinib when administered in combination with corticosteroids in the study population.
    - To estimate efficacy outcomes.
    Part 2:
    - To compare changes in health-related quality of life.
    - To compare additional efficacy outcomes between treatment groups.
    - To evaluate the PK of itacitinib in combination with corticosteroids in 1L cGVHD.
    - To evaluate the safety and tolerability of study treatment across the 2 treatment cohorts.
    Parte 1
    - Evaluar la FC de itacitinib cuando se administra en combinación con corticoesteroides en la población del studio.
    - Calcular los resultados de eficacia.
    Parte 2
    - Comparar los cambios en la calidad de vida relacionada con la salud.
    - Comparar otros resultados de eficacia entre los grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 18 years or older inclusive at the time of signing the ICF.
    2. Active, clinically diagnosed, moderate or severe cGVHD per NIH Consensus Criteria :
    a. Moderate cGVHD: At least 1 organ (except lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1.
    b. Severe cGVHD: At least 1 organ with a score of 3, or lung score of 2 or 3.
    Note: Candidates who transition from active aGVHD to cGVHD without tapering off of corticosteroids (< 0.25 mg/kg per day) ± CNI are also eligible.
    3. Underwent allo-HCT from any donor HLA type (related, or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative or reduced intensity conditioning are eligible.
    4. KPS score ≥ 60%.
    5. Evidence of myeloid and platelet engraftment, that is, ANC ≥ 1.0 × 109/L and platelet count ≥ 25 × 109/L. Note: Use of growth factor supplementation and transfusion support is allowed during the study; however, transfusion to reach a minimum platelet count for inclusion is not allowed within the 7 days before the screening laboratory assessment
    1. Hombres o mujeres, de 18 años o mayores en el momneto de firmar el Consentimiento informado.
    2. EICHc activa, clínicamente diagnosticada, moderada o grave según los criterios de consenso de los NIH:
    a. EICHc moderada: al menos 1 órgano (excepto el pulmón) con una puntuación de 2, 3 ó más órganos involucrados con una puntuación de 1 en cada órgano, o una puntuación pulmonar de 1.
    b. EICHc grave: al menos 1 órgano con una puntuación de 3, o puntuación pulmonar de 2 ó 3.

    Nota: Los candidatos que hacen la transición de EICHc activa a EICHc sin disminuir los corticosteroides (<0,25 mg / kg por día) ± CNI también son elegibles.

    3. Se sometió a alo-HCT de cualquier tipo de HLA de donante (donante relacionado o no relacionado con cualquier grado de compatibilidad HLA) utilizando cualquier fuente de injerto (médula ósea, células madre de sangre periférica o sangre del cordón umbilical). Los beneficiarios de acondicionamiento mieloablativo o de intensidad reducida son elegibles.

    4. KPS puntuación ≥ 60%.

    5. Evidencia de injerto de mieloide y plaquetas, es decir, ANC ≥ 1,0 × 109 / L y recuento de plaquetas ≥ 25 × 109 / L.

    Nota: El uso de suplementos de factor de crecimiento y soporte de transfusión está permitido durante el estudio; sin embargo, la transfusión para alcanzar un recuento de plaquetas mínimo para la inclusión no está permitida en los 7 días antes del examen de laboratorio de selección.
    E.4Principal exclusion criteria
    1. Has received more than 1 prior allo-HCT.
    2. Has received more than 3 days/72 hours of systemic corticosteroid treatment for cGVHD.
    3. Has received any other systemic treatment for cGVHD, including ECP. Prior and concomitant use of CNIs as well as topical/inhaled steroids is acceptable.
    4. Prior treatment with a JAK inhibitor for aGVHD, unless the participant achieved complete or partial response and has been off JAK inhibitor treatment for at least 8 weeks before randomization.
    5. cGVHD occurring after a nonscheduled DLI administered for pre-emptive treatment of malignancy recurrence. Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
    1. Haber recibido más de 1 alo-TCH previamente.
    2. Ha recibido más de 3 días / 72 horas de tratamiento corticosteroide sistémico para EICH.
    3. Haber recibido cualquier otro tratamiento sistémico para la EICH, incluida la Fotoaféresis extracorpórea (FEC). El uso previo y concomitante de los CNI, así como los esteroides tópicos / inhalados, es aceptable.
    4. Tratamiento previo con un inhibidor de la quinasa Janus (JAK) para EICH, a menos que el participante logre una respuesta completa o parcial y haya estado fuera del tratamiento con el inhibidor de JAK durante al menos 8 semanas antes de la aleatorización.
    5. EICH que ocurre después de una Infusión de Linfocitos del Donante (ILD) no programada administrada para el tratamiento preventivo de la recurrencia de malignidad. Los participantes que hayan recibido una ILD programada como parte de su procedimiento de trasplante y no para el tratamiento de la recaída de malignidad son elegibles.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: DLT data through Day 28 and additional data from clinical safety and laboratory assessments.
    Part 2: Response rate at Month 6, defined as the proportion of participants demonstrating a CR or PR at Month 6.
    Parte 1: datos de Dosis limitante de toxicidad (DLT) hasta el día 28 y datos adicionales de seguridad clínica y evaluaciones de laboratorio.
    Parte 2: Tasa de respuesta en el Mes 6, definida como la proporción de participantes que se presentan a RC o RP en el Mes 6.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part 1: through Day 28
    Part 2: at Month 6
    Parte 1: hasta el día 28
    Parte 2: mes 6
    E.5.2Secondary end point(s)
    Part 1:
    - Cmax, Cmin, Tmax, AUC0-t, and Cl/F.
    - Response rate at Month 3, 6, and 12, defined as the proportion of participants who demonstrate either a CR or PR at each timepoint.
    - Time to response, defined as the interval between randomization and first response.
    - DoR, defined as the interval between first response and cGVHD progression, death, or initiation of new systemic cGVHD therapy.
    - OS, defined as the interval between the date of randomization and the date of death due to any cause.
    - NRM, defined as the proportion of participants who died due to causes other than a relapse of their primary hematologic disease.
    - Proportion of participants with ≥ 50% reduction in daily corticosteroid dose at Day 180.
    - Proportion of participants successfully tapered off all corticosteroids at Day 180.
    - Relapse rate of malignant and non-malignant hematologic diseases, defined as the proportion of participants whose underlying disease relapses.
    - Time to primary hematologic disease relapse, defined as the interval between the date of randomization and the date of relapse.

    Part 2:
    - Changes in symptom scores using the LSS, QOL-SF-36 v2, and EQ-5D-3L.
    - Response rate at Month 3 and 12, defined as the proportion of participants who demonstrate either a CR or PR at each timepoint.
    - DoR, defined as the interval between first response and cGVHD progression, death, or initiation of new systemic cGVHD therapy.
    - OS, defined as the interval between the date of randomization and the date of death due to any cause.
    - NRM, defined as the proportion of participants who died due to causes other than a relapse of their primary hematologic disease.
    - Proportion of participants with ≥ 50% reduction in daily corticosteroid dose at Day 180.
    - Proportion of participants successfully tapered off all corticosteroids at Day 180.
    - Relapse rate of malignant and non-malignant hematologic diseases, defined as the proportion of participants whose underlying disease relapses.
    - Time to primary hematologic disease relapse, defined as the interval between the date of randomization and the date of relapse.
    - Cmin in all participants; Cmax, Tmax, AUC0-t, and Cl/F, data permitting.
    - Data from clinical safety assessments (eg, AEs, infections) will be listed and tabulated.
    Parte 1:
    - Cmáx, Cmín, Tmáx, ABC0-t, y Acl/F.
    - Tasa de respuesta en los meses 3, 6 y 12, definida como la proporción de participantes que muestran RC o RP en cada punto temporal.
    - Tiempo hasta la respuesta, definido como el intervalo entre la aleatorización y la primera respuesta.
    - Duración de la respuesta (DR), definida como el intervalo entre la primera respuesta y la progresión de la EICHc, la muerte o el inicio un tratamiento sistémico nuevo para la EICHc.
    - Supervivencia general (SG), definida como el intervalo entre la fecha de la aleatorización y la fecha de la muerte por cualquier causa.
    - Mortalidad sin recidiva (MSR), definida como la proporción de participantes que murieron por causas distintas de la recidiva de la enfermedad hematológica principal.
    - Proporción de participantes con una reducción ≥50 % en la dosis diaria de corticoesteroides el día 180.
    - Proporción de participantes que redujeron gradualmente de manera satisfactoria todos los corticoesteroides el día 180.
    - Tasa de recidiva de enfermedades hematológicas benignas y malignas, definida como la proporción de participantes con recidiva de la enfermedad subyacente.
    - Calcular los resultados de eficacia.
    - Tiempo hasta la recidiva de la enfermedad hematológica principal, definido como el intervalo entre la fecha de la aleatorización y la fecha de la recidiva.
    Parte 2:
    - Cambios en las puntuaciones de síntomas utilizando la escala de satisfacción con la vida (Lee Symptom Scale, LSS) y los cuestionarios de calidad de vida QOL-SF- 36 v2 y EQ-5D-3L.
    - Tasa de respuesta en los meses 3 y 12, definida como la proporción de participantes que muestran RC o RP en cada punto temporal.
    - Duración de la respuesta (DR), definida como el intervalo entre la primera respuesta y la progresión de la EICHc, la muerte o el inicio un tratamiento
    sistémico nuevo para la EICHc.
    - Supervivencia general (SG), definida como el intervalo entre la fecha de la aleatorización y la fecha de la muerte por cualquier causa.
    - Mortalidad sin recidiva (MSR), definida como la proporción de participantes que murieron por causas distintas de la recidiva de la enfermedad hematológica
    principal.
    - Proporción de participantes con una reducción ≥50 % en la dosis diaria de corticoesteroides el día 180.
    - Proporción de participantes que redujeron gradualmente de manera satisfactoria todos los corticoesteroides el día 180.
    - Tasa de recidiva de enfermedades hematológicas benignas y malignas, definida como la proporción de participantes con recidiva de la enfermedad.
    - Tiempo hasta la recidiva de la enfermedad hematológica principal, definido como el intervalo entre la fecha de la aleatorización y la fecha de la
    recidiva.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part 1: Month 3, 6 and 12
    Part 2: Month 3, 6, 12
    Parte 1: meses 3, 6 y 12
    Parte 2: meses 3, 6 y 12
    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 Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Parte 1: aleatorizado, abierto; Parte 2: aleatorizado, doble ciego, controlado con place
    Part 1: randomized, open-label; Part 2: randomized, double-blind, placebo-controlled
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Poland
    Spain
    Sweden
    United Kingdom
    United States
    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 study will end once all randomized patients have reached Month 36 or discontinued the study early due to any reason.
    El estudio finalizará una vez que todos los pacientes asignados al azar hayan alcanzado el Mes 36 o hayan interrumpido el estudio antes de tiempo por cualquier motivo.
    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 months0
    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 months0
    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: 213
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 53
    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 state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 266
    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)
    None
    Ninguno
    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 Decision2019-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-08
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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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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