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    Summary
    EudraCT Number:2020-003406-31
    Sponsor's Protocol Code Number:CCMK389B12201
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-14
    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 number2020-003406-31
    A.3Full title of the trial
    A randomized, subject and investigator blinded, placebo-controlled multicenter study to assess the efficacy and safety of CMK389 in patients with moderate to severe atopic dermatitis
    Estudio multicéntrico, aleatorizado, doble ciego (paciente e
    investigador) y controlado con placebo para evaluar la eficacia y la
    seguridad de CMK389 en pacientes con dermatitis atópica de
    moderada a grave.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess if CMK389 is effective, safe and tolerable in patients with moderate to severe Atopic Dermatitis (AD)
    Estudio de eficacia y seguridad de CMK389 en participantes con
    dermatitis atópica de moderada a grave.
    A.4.1Sponsor's protocol code numberCCMK389B12201
    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 Farmacéutica S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    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.3.2Product code CMK389
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.2Current sponsor codeCMK389
    D.3.9.4EV Substance CodeSUB191055
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) 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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to Severe Atopic Dermatitis
    Dermatitis atópica de moderada a grave
    E.1.1.1Medical condition in easily understood language
    Atopic dermatitis / eczema
    Dermatitis atópica/eccema
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    E.1.2System Organ Class 100000004858
    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 efficacy of CMK389 in participants with moderate to severe AD
    Evaluar la eficacia de CMK389 en participantes con
    DA de moderada a grave.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of CMK389 in participants with AD
    Evaluar la seguridad y la tolerabilidad de CMK389 en participantes con DA de moderada a grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult male or female participants with chronic atopic dermatitis, according to the American Academy of Dermatology Consensus Criteria (Eichenfield et al 2014), aged 18 to 65 years, present for at least 1 year before screening.
    - Moderate to severe AD defined as:
    --IGA score of ≥ 3 (on a scale of 0 to 4, in which 3 is moderate and 4 is severe) at Baseline (or Screening if Baseline is omitted)
    --EASI score of ≥ 12 at Baseline (or Screening if Baseline is omitted)
    --Pruritus (NRS) of at least ≥ 3 at Baseline (or Screening if Baseline is omittied)
    - Participants who are candidates for a systemic therapy, defined as e.g. inadequate response to treatment with topical medications, or from whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks, patients with large affected body surface areas), as assessed by the investigator
    - Participants must have a body mass index (BMI) at screening within the range of 18 to ≤35 kg/m2.
    Other criteria may apply as per protocol,
    -Participantes adultos de 18 a 65 años de ambos sexos con DA crónica, según los criterios de consenso de la Academia Estadounidense de Dermatología (AAD) (Eichenfield et al., 2014), que haya estado presente durante al menos un año antes de la selección.
    - La DA de moderada a grave se define como:
    - Puntuación de la evaluación global del investigador (IGA) >/=3 (en una escala de 0 a 4, en la que 3 equivale a moderado y 4 a grave) en la basal (o en la selección si se omite la basal).
    - Puntuación del Eczema Area and Severity Index (EASI) >/=12 en la basal (o en la selección si se omite la basal).
    - Escala numérica de prurito con un valor de al menos >/=3 en la basal (o en la selección si se omite la basal).
    - Participantes que sean candidatos para un tratamiento sistémico, definido como p. ej., una respuesta inadecuada al tratamiento con medicamentos tópicos, o para quienes los tratamientos tópicos no sean médicamente aconsejables (p. ej., debido a efectos secundarios importantes o riesgos de seguridad, pacientes con grandes áreas de superficie corporal afectadas), según lo evalúe el investigador.
    - Los participantes deben tener un índice de masa corporal (IMC) en la selección de entre 18 y </=35 kg/m2. IMC = peso corporal
    (kg)/[estatura (m)]2.
    E.4Principal exclusion criteria
    - Any skin disease that, in the opinion of the investigator, would confound the diagnosis or evaluation of AD disease activity (e.g., Netherton Syndrome, or other ichthyoses, cutaneous T-Cell Lymphoma, extensive contact dermatitis, chronic actinic dermatitis and other forms of eczema, such as seborrheic and microbial eczema).
    - Participants taking prohibited medication with their wash out period
    - Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or longer if required by local regulations.
    - Any active, recent or recurrent systemic or localized infection at screening or prior to first treatment which in the opinion of the investigator immunocompromises the participant and/or places the participant at unacceptable risk for immunomodulatory therapy.
    - Any other current or past clinical significant medical condition, including psychiatric condition, which in the investigator's opinion may interfere with safety of participants, study objectives or adherence to the protocol.
    - Participants with confirmed abnormal absolute neutrophil count (ANC) of <1.5 x 109/L or with thrombocytopenia of < 75.0 x 109/L at screening and baseline (unless baseline visit is omitted)
    - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
    - History of hypersensitivity to any component of the study drug product, or to drugs of similar chemical classes (i.e., IgG-1 related biologic agents)
    - History of severe or serious allergy or hypersensitivity reactions, such as anaphylactic shock, asthma, or uncontrolled urticaria.
    - Women of child-bearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 6 months after last dose.
    - Cualquier enfermedad cutánea que, a juicio del investigador, confundiría el diagnóstico o evaluación de la actividad de la DA (p.ej., síndrome de Netherton u otros trastornos ictiósicos, linfoma cutáneo de células T, dermatitis de contacto extensa, dermatitis actínica crónica y otras formas de eczema, como eczema seborreico o eczema microbiano.)
    - Participantes que tomen medicación prohibida que no completen el periodo de lavado como se especifica en la Tabla 6-2.
    - Uso de otros fármacos en investigación en el momento del reclutamiento o durante las 5 vidas medias anteriores al reclutamiento o hasta que el efecto PD previsto vuelva a los valores basales, aquel periodo que sea más largo; o durante más tiempo si así lo exige la normativa local.
    - Cualquier infección sistémica o localizada activa, reciente o recurrente en la selección o antes del primer tratamiento que, a juicio del investigador, inmunodeprima al participante y/o le coloque en un riesgo inaceptable para la terapia inmunomoduladora.
    - Cualquier otra enfermedad actual o pasada de interés clínico, incluyendo una enfermedad psiquiátrica, que, a juicio del investigador, pueda interferir en la seguridad de los participantes, los objetivos del estudio o el cumplimiento del protocolo.
    - Participantes con recuento absoluto de neutrófilos (RAN) anormal confirmado <1,5 x 109/l o con trombocitopenia <75,0 x 109/l en la selección y la basal (a menos que se omita la visita basal).
    - Antecedentes de tumor maligno en cualquier sistema orgánico (salvo carcinoma cutáneo de células basales localizado), tratado o no tratado, durante los últimos 5 años, independientemente de que existan o no pruebas de recurrencia local o metástasis.
    - Antecedentes de hipersensibilidad a alguno de los componentes del fármaco del estudio o a fármacos de clases químicas similares (es decir, agentes biológicos relacionados con IgG-1).
    - Antecedentes de reacciones alérgicas o de hipersensibilidad intensas o graves, como shock anafiláctico, asma o urticaria incontrolada.
    - Mujeres con posibilidad de quedarse embarazadas, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, salvo que esté utilizando métodos anticonceptivos altamente eficaces durante el tratamiento del estudio y durante los 6 meses posteriores a la última dosis.
    E.5 End points
    E.5.1Primary end point(s)
    IGA response (defined as clear or almost clear and at least 2 point reduction from baseline)
    Respuesta de la IGA (definida como aclaramiento total o aclaramiento casi total y una reducción de al menos 2 puntos respecto a la basal)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    En la semana 16
    E.5.2Secondary end point(s)
    Number, seriousness and frequency of Adverse events over time
    Número, severidad y frecuencia de acontecimientos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    From Baseline to EoS.
    Desde la basal hasta final de estudio
    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 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) 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 trial4
    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 EEA26
    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
    France
    Germany
    Hungary
    Poland
    Spain
    United Kingdom
    Czechia
    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
    Study completion is defined as when the last participant finishes their End of study (EOS) visit.
    La finalización del estudio se define cuando el último paciente realiza la visita de fin de estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days20
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 64
    F.1.3Elderly (>=65 years) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 64
    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
    Ninguino
    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 Decision2021-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
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