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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-004529-57
    Sponsor's Protocol Code Number:EQ-100-02
    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:2022-03-21
    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 number2021-004529-57
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease
    Estudio multicéntrico en fase III, aleatorizado, con enmascaramiento doble, controlado con placebo, de itolizumab en combinación con corticoesteroides para el tratamiento inicial de la enfermedad aguda del injerto contra el anfitrión
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Study of Itolizumab in Combination with Corticosteroids for the Initial Treatment of Acute Graft Versus Host Disease (Complication of Bone Marrow Transplants)
    Un estudio de fase 3 de Itolizumab en combinación con corticosteroides para el tratamiento inicial de la enfermedad aguda del injerto contra el anfitrión (complicación de los trasplantes de médula ósea)
    A.4.1Sponsor's protocol code numberEQ-100-02
    A.5.4Other Identifiers
    Name:IND numberNumber:139877
    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 SponsorEquillium, 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 supportEquillium, Inc.
    B.4.2CountryUnited States Minor Outlying Islands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEquillium, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address2223 Avenida de la Playa, Suite 108
    B.5.3.2Town/ cityLa Jolla
    B.5.3.3Post codeCA 92037
    B.5.3.4CountryUnited States
    B.5.4Telephone number1858240-1200
    B.5.6E-mailclinicaltrials@equilliumbio.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/3/21/2463
    D.3 Description of the IMP
    D.3.1Product nameItolizumab
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNITOLIZUMAB
    D.3.9.1CAS number 1116433-11-4
    D.3.9.2Current sponsor codeEQ001
    D.3.9.4EV Substance CodeSUB184388
    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 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 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) Yes
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Graft Versus Host Disease
    Enfermedad aguda de injerto contra huésped
    E.1.1.1Medical condition in easily understood language
    Acute Graft Versus Host Disease (Complication of Bone Marrow Transplants)
    Enfermedad aguda de injerto contra huésped (complicación de los trasplantes de médula ósea)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level LLT
    E.1.2Classification code 10059044
    E.1.2Term Allogeneic peripheral hematopoietic stem cell transplant
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018799
    E.1.2Term GVHD
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response.
    Evaluar la eficacia de itolizumab en comparación con placebo como tratamiento inicial para la EICAa en combinación con corticoesteroides para lograr una respuesta temprana a la enfermedad
    E.2.2Secondary objectives of the trial
    • To evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids.
    • To evaluate systemic corticosteroid use in subjects treated with itolizumab versus placebo.
    • To assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, including survival outcomes and cGVHD incidence.
    • To evaluate the safety and tolerability of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids
    •Evaluar la durabilidad de la respuesta a itolizumab en comparación con placebo como tratamiento inicial para la EICAa en combinación con corticoesteroides.
    •Evaluar el uso de corticoesteroides sistémicos en sujetos tratados con itolizumab en comparación con placebo.
    •Evaluar el impacto del itolizumab en comparación con placebo sobre otras medidas de eficacia clínicamente relevantes, incluidos los resultados de supervivencia y la incidencia de EICAc.
    •Evaluar la seguridad y tolerabilidad de itolizumab en comparación con placebo como tratamiento inicial para la EICAa en combinación con corticoesteroides
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥12 years and >40 kg at informed consent/assent. Subjects <18 years may only enroll after the initial DMC data review, if locally permitted.
    - Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
    - Has evidence of myeloid engraftment, defined as an absolute neutrophil count ≥500/mm3 (or ≥0.5 × 10exp9/L) achieved and sustained for 3 laboratory values obtained on different days. Laboratory
    values prior to Screening may be used.
    - Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria. Biopsies to confirm aGVHD should be obtained but are not required and should not delay entry into the study.
    - Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.
    Tener ≥12 años y >40 kg en el momento del consentimiento/asentimiento informado. Los sujetos menores de 18 años solamente pueden inscribirse después de la revisión inicial de datos del CVDS, si está permitido localmente.
    Haberse sometido a un aloinjerto TCMH inicial para cualquier indicación utilizando cualquier fuente de injerto, fuente de donante, intensidad de la pauta de acondicionamiento o profilaxis.
    Tener evidencia de injerto mieloide, definido como un recuento absoluto de neutrófilos ≥500/mm3 (o ≥0,5 × 109/l) alcanzado y sostenido durante 3 valores de laboratorio obtenidos en diferentes días. Se pueden utilizar los valores de laboratorio previos a la selección.
    Tener un diagnóstico clínico de EICAa de Grados III-IV o Grado II con afectación del TDB basado en los Criterios de clasificación de la EICA aguda del Consorcio Internacional Monte Sinaí (Mount Sinai Acute GVHD International Consortium, MAGIC). Deben obtenerse biopsias para confirmar la EICAa, pero no son obligatorias y no deben retrasar la entrada en el estudio.
    Haber comenzado el tratamiento con corticoesteroides sistémicos para la EICAa ≤72 horas antes del inicio de las dosis del fármaco del estudio Y debe recibir 2 mg/kg/día de metilprednisolona o equivalente el día 1
    E.4Principal exclusion criteria
    - Has evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
    - Has an unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
    - Has evidence of persistent molecular disease requiring treatment (eg, standard chemotherapy or tyrosine kinase inhibitors) that was not specified prior to HSCT.
    -Has evidence of cGVHD or overlap syndrome, as defined by 2014 NIH Consensus Criteria.
    - Is using immunosuppressants other than corticosteroids for the treatment of aGVHD. Continued use of immunosuppressants as GVHD prophylaxis agents is permitted.
    - Has received any systemic corticosteroids of >0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD. Systemic corticosteroids administered as premedication before blood product transfusions or IV medications to prevent infusion-related reactions are allowed.
    - Has a clinically active, uncontrolled bacterial, viral, or fungal infection, despite adequate treatment. No signs of progression of the infection can be present at randomization. Asymptomatic cytomegalovirus (CMV), Epstein–Barr virus (EBV), or human Herpesvirus 6 (HHV-6) viremia based on viral load or a viral load that is declining with treatment does not constitute a clinically active infection.

    Other protocol-defined exclusion criteria apply.
    Tener evidencia de neoplasia maligna morfológica en recaída, progresiva, persistente o no tratada, con la excepción de cáncer de piel no melanomatoso y carcinoma ductal in situ de mama.
    Tener una infusión de linfocitos de donante no planificada para neoplasias malignas persistentes o recurrentes después de un TCMH.
    Tener evidencia de enfermedad molecular persistente que requiere tratamiento (p. ej., quimioterapia estándar o inhibidores de la tirosina cinasa) que no se especificó antes del TCMH.
    Tener evidencia de EICAc o síndrome de superposición, según se define en los Criterios de consenso de los NIH de 2014.
    Estar usando inmunodepresores distintos de los corticoesteroides para el tratamiento de la EICAa. Se permite el uso continuado de inmunodepresores como agentes para la profilaxis de la EICA.
    Haber recibido cualquier corticoesteroide sistémico a >0,5 mg/kg/día de metilprednisolona o equivalente para cualquier indicación distinta de la EICAa dentro de los 7 días anteriores al inicio de la EICAa. Se permiten los corticoesteroides sistémicos administrados como premedicación antes de la transfusión de productos derivados de la sangre o medicamentos i.v. para prevenir reacciones relacionadas con la infusión.
    Tener una infección bacteriana, vírica o micótica clínicamente activa y no controlada, a pesar del tratamiento adecuado. No puede haber signos de progresión de la infección en la aleatorización. Las viremias por citomegalovirus (CMV) asintomáticas, virus de Epstein-Barr (VEB) o herpesvirus humano 6 (HVH-6) basadas en la carga viral o una carga viral que está disminuyendo con el tratamiento no constituyen una infección clínicamente activa.

    Se aplican otros criterios de exclusión definidos por el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    Complete Response rate at Day 29.
    Objetivo principal
    Tasa de respuesta completa en el día 29.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint
    Day 29
    Objetivo principal
    Día 29
    E.5.2Secondary end point(s)
    Key secondary endpoints:

    1) Overall response rate at day 29
    2) Durable complete response rate from Day 29 through Day 99
    Criterios de valoración secundarios clave:

    1) Tasa de respuesta global en el día 29
    2) Tasa de respuesta completa duradera desde el día 29 hasta el día 99
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 29
    2) Day 29 through Day 99
    1) Día 29
    2) Del día 29 al 99
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other 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 concerned10
    E.8.5The trial involves multiple Member States No
    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
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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)
    standard of care
    normas de atención
    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 Decision2022-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-27
    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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