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    Summary
    EudraCT Number:2020-004937-19
    Sponsor's Protocol Code Number:CMHV370A12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-08-05
    Trial results View 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 number2020-004937-19
    A.3Full title of the trial
    A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease
    Estudio en cesta multicéntrico, aleatorizado, doble ciego (participante e
    investigador), controlado con placebo y de grupos paralelos para evaluar la
    seguridad, la tolerabilidad y la eficacia de MHV370 en participantes con
    síndrome de Sjögren o enfermedad mixta del tejido conectivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)
    Un estudio para evaluar la seguridad, la tolerabilidad y la eficacia de MHV370 en participantes con síndrome de Sjögren (SS) o enfermedad mixta del tejido conectivo (EMTC).
    A.4.1Sponsor's protocol code numberCMHV370A12201
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmácéutica, S.A.
    B.5.2Functional name of contact pointTMo
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 93 3064464
    B.5.5Fax numberNAP
    B.5.6E-maileecc.novartis@novartis.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 nameMHV370
    D.3.2Product code MHV370
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot yet established
    D.3.9.2Current sponsor codeMHV370
    D.3.9.4EV Substance CodeSUB191746
    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 placeboCapsule, hard
    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
    Sjögren’s syndrome
    Mixed connective tissue disease
    Síndrome de Sjögren
    Enfermedad mixta del tejido conectivo
    E.1.1.1Medical condition in easily understood language
    Sjögren’s syndrome
    Mixed connective tissue disease
    Síndrome de Sjögren
    Enfermedad mixta del tejido conectivo
    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 21.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10027754
    E.1.2Term Mixed connective tissue disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - SjS participants: to evaluate the efficacy of MHV370 compared to placebo based on change from baseline in ESSDAI at Week 24
    - MCTD participants: to evaluate the efficacy of MHV370 compared to placebo based on change from baseline in Physician Global Assessment (PhGA) at Week 24
    - SS: Evaluar la eficacia de MHV370 comparado con placebo según el cambio respecto a la basal en el ESSDAI en la semana 24.
    - EMTC: Evaluar la eficacia de MHV370 comparado con placebo según el cambio respecto a la basal en la evaluación global del médico (PhGA en la semana 24.
    E.2.2Secondary objectives of the trial
    SjS and MCTD:
    To evaluate the efficacy of MHV370 compared to placebo based on change from baseline on patient and physician-reported outcomes over time up to Week 24
    To evaluate the safety and tolerability of MHV370
    To assess PK parameters of MHV370
    SjS:
    To explore the effect of MHV370 on quantitative salivary flow (unstimulated) over 24 weeks
    To explore the effect of MHV370 on quantitative tear production over 24 weeks
    MCTD:
    To evaluate the efficacy of MHV370 based on change from baseline in Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV1, FEV2, FEV3) over time up to Week 24
    To evaluate the efficacy of MHV370 based on change from baseline in the diffusing capacity of lungs for carbon monoxide (DLCO) over time up to Week 24
    To evaluate the efficacy of MHV370 based on change from baseline in the patient reported outcome on lung function
    To evaluate the efficacy of MHV370 based on change from baseline in Raynaud's Condition Score (RCS) over time up to Week 24
    SS y EMTC:
    Evaluar eficacia de MHV370 comparado con placebo según cambio respecto a la basal en resultados comunicados por paciente y por el médico en el tiempo hasta la semana 24 (W24)
    Evaluar seguridad y tolerabilidad de MHV370.
    Evaluar parámetros PK de MHV370
    SS:
    Explorar efecto de MHV370 en flujo salival cuantitativo (no estimulado) y en producción cuantitativa de lágrimas durante W24
    EMTC:
    Evaluar eficacia de MHV370 según cambio respecto a la basal en capacidad vital forzada (FVC) y volumen espiratorio forzado (FEV1, FEV2, FEV3) en el tiempo hasta W24
    Evaluar eficacia de MHV370 según cambio respecto a la basal en capacidad de difusión pulmonar de monóxido de carbono (DLCO) en el tiempo hasta W24
    Evaluar eficacia de MHV370 según cambio respecto a la basal en resultado comunicado por paciente en la función pulmonar.
    Evaluar eficacia de MHV370 comparado con placebo según el cambio respecto a la basal en la Raynaud's Condition Score (RCS) en el tiempo hasta W24
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    SjS and MCTD:
    - Fully vaccinated with any locally approved COVID-19 vaccination at least 4 weeks prior to baseline
    SjS:
    - Unstimulated whole salivary flow rate of > 0 mL/min at screening
    - Classification of Sjögren's Syndrome according to the 2016 ACR/EULAR criteria at screening
    - Screening ESSDAI (based on weighted score) >/= 5 from 8 defined domains (biologic, hematologic, articular, cutaneous, glandular, lymphadenopathy, renal, constitutional).
    MCTD:
    - Diagnosis of MCTD based on a)Raynaud’s phenomenon b) At least two of the four following signs: i) synovitis, ii) myositis, iii) swollen fingers and vi) interstitial lung disease
    - Patients with overlap syndromes, i.e. patients meeting diagnostic criteria for systemic autoimmune disease other than MCTD may be included unless they have major organ involvement as judged by the investigator

    Other protocol inclusion criteria may apply.
    SS y EMTC:
    - Vacunados totalmente con cualquier vacuna contra la COVID-19 aprobada localmente al menos 4 semanas antes de la basal.
    - Tasa de flujo salival no estimulado >0 ml/min en la selección
    - Clasificación del síndrome de Sjögren según los criterios de 2016 ACR/EULAR en la selección.
    - ESSDAI en la selección (según la puntuación ponderada) >/= 5 de 8 dominios definidos (biológico, hematológico, articular, cutáneo, glandular, linfadenopatía, renal, constitucional).
    EMTC:
    - Diagnóstico de EMTC según a)Fenómeno de Raynaud b)Al menos dos de los cuatro signos siguientes: i) sinovitis, ii)miositis, ii) dedos hinchados y vi) enfermedad pulmonar intersticial.
    - Pacientes con síndromes de superposición, es decir, pacientes que cumplan los criterios de diagnóstico para una enfermedad autoinmune sistémica que no sea la EMTC a menos que afecten a un órgano principal según el investigador.

    Pueden aplicar otros criterios de inclusión del protocolo.
    E.4Principal exclusion criteria
    SjS and MCTD:
    - Prior use of B-cell depleting therapy within 6 months of baseline. For participants who received B-cell depleting therapy within 6 -12 months of baseline visit, B-cell count should be within normal range
    - Prior treatment with any of the following within 3 months of baseline: CTLA4-Fc Ig (abatacept), Anti-TNF mAb, Intravenous Ig, Plasmapheresis, i.v. or oral cyclophosphamide, i.v. or oral cyclosporine A
    - Screening CBC laboratory values as follows: Hemoglobin levels < 8 g/dL (< 5 mmol/L), Total leukocyte count < 2,000/μL (2 x 109/L), Platelets < 50,000/μL (50 x 109/L), Neutrophil count < 1,000/μL (1 x 109/L)
    - Pregnant or nursing (lactating) women
    - Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they use a highly effective method of contraception
    SjS:
    - Sjögren’s Syndrome overlap syndromes where another autoimmune disease constitutes the primary illness
    - Required regular use of medications known to cause, as a major side effect, dry mouth / eyes

    Other protocol-defined exclusion criteria may apply
    SS y EMTC:
    - Uso anterior de terapia de depleción de células B durante los 6 meses anteriores a la basal. Para los participantes que hayan recibido terapia de depleción de células B durante los 6 - 12 meses anteriores a la visita basal, el recuento de células B debe estar dentro del intervalo normal.
    - Tratamiento previo con cualquiera de los fármacos siguientes durante los 3 meses anteriores a la basal: CTLA4-Fc de Ig (abatacept), Anticuerpo Monoclonal anti-TNF, lg intravenosa, Plasmaféresis, Ciclofosfamida i.v. o por vía oral,  Ciclosporina A i.v. o por vía oral.
    - Valores de laboratorio de recuento sanguíneo completo (CBC) en la selección como: Niveles de hemoglobina <8 g/dl (<5 mmol/l), Recuento total de leucocitos <2000/μl (2 x 109/l), Plaquetas <50 000/μl (50 x 109/l), Recuento de neutrófilos <1000/μl (1 x 109/l).
    - Mujeres embarazadas o en periodo de lactancia.
    - Mujeres con posibilidad de quedarse embarazadas, definidas como todas las mujeres fisiológicamente capaces de quedarse embarazadas, salvo que utilicen un método anticonceptivo altamente eficaz.
    SS:
    - Síndromes de superposición del síndrome de Sjögren en los que otra enfermedad autoinmune constituye la enfermedad principal.
    - Se requiere el uso habitual de medicación que se sepa que cause boca/ojos secos como efecto secundario principal

    Pueden aplicar otros criterios de exclusión del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    - SjS participants: change from baseline in Eular Sjögren's Disease Activity Index (ESSDAI) after 24 weeks of treatment
    - MCTD participants: change from baseline in physician’s global assessment scale (PhGA) after 24 weeks of treatment
    - SS: cambio respecto a la basal en el ESSDAI después de 24 semanas de tratamiento.
    - EMTC: cambio respecto a la basal en la evaluación global del médico (PhGA) después de 24 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 24
    Basal, semana 24
    E.5.2Secondary end point(s)
    SjS and MCTD participants:
    - Maximum Observed Blood Concentrations (Cmax) of MHV370 at steady state
    - Area under the blood concentration-time curve from time zero to time of last measurable concentration (AUClast) of MHV370 at steady state
    - Time to Reach Maximum Blood Concentrations (Tmax) of MHV370 at steady state
    - Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale
    - Change from baseline in Physician Global Assessment (PhGA)
    SjS participants:
    - Change from baseline in Eular Sjögren’s Syndrome Disease Activity Index (ESSDAI)
    - Change from baseline in Eular Sjögren's Syndrome Patient Reported Index (ESSPRI)
    - Change from baseline to the salivary flow rate
    - Change from baseline to the Schirmer’s test
    MCTD participant:
    - Change from baseline in articular and pulmonary domains of the Eular Sjögren’s Syndrome Disease Activity Index (ESSDAI)
    - Change from baseline in Forced Vital Capacity (FVC)
    - Change from baseline in Forced expiratory volume during the first second (FEV1) of a forced breath
    - Change from baseline in Forced expiratory volume during the first two seconds (FEV2) of a forced breath
    - Change from baseline in Forced expiratory volume during the first three seconds (FEV3) of a forced breath
    - Change from baseline in the diffusing capacity of the lungs for carbon monoxide (DLCO)
    - Change from baseline in King’s Brief Interstitial Lung Disease (K-BILD)
    - Change from baseline in Raynaud’s Condition Score (RCS)
    SS y EMTC:
    - (Cmax) de MHV370 en estado estacionario
    - Área bajo la curva de concentración en sangre-tiempo desde el tiempo cero hasta el momento AUClast de MHV370 en estado estacionario
    - Tiempo para alcanzar Tmax de MHV370 en estado estable
    - Cambio con respecto a la basal en la escala de FACIT-F
    - Cambio con respecto a la basal en la PhGA
    SS:
    - Cambio con respecto a la basal en ESSDAI
    - Cambio con respecto a la basal en ESSPRI
    - Cambio con respecto a la basal en la tasa de flujo salival
    - Cambio con respecto a la basal en el test de Schirmer
    EMTC:
    - Cambio con respecto a la basal en los dominios articular y pulmonar del ESSDAI
    - Cambio con respecto a la basal en FVC
    - Cambio con respecto a la basal en el volumen espiratorio forzado durante el primer segundo (FEV1) de una respiración forzada
    - Cambio con respecto a la basal en el volumen espiratorio forzado durante los primeros dos segundos (FEV2) de una respiración forzada
    - Cambio con respecto a la basal en el volumen espiratorio forzado durante los primeros tres segundos (FEV3) de una respiración forzada
    - Cambio con respecto a la basal en la capacidad de difusión pulmonar de monóxido de carbono (DLCO)
    - Cambio con respecto a la basal en K-BILD
    - Cambio con respecto a la basal en la Raynaud's Condition Score (RCS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per the assessment schedule provided in scope of Clinical Study Protocol
    Según el programa de evaluación proporcionado en protocolo de estudio clínico
    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 No
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    China
    Israel
    Taiwan
    Germany
    Hungary
    Poland
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    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 months2
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 60
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-07
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