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    Summary
    EudraCT Number:2022-000520-38
    Sponsor's Protocol Code Number:22158
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-11-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2022-000520-38
    A.3Full title of the trial
    A randomized, placebo-controlled, double-blind, parallel-group, multicenter Phase 2a study to investigate efficacy and safety of zabedosertib (BAY 1834845) for the treatment of adult patients with moderate-to-severe atopic dermatitis
    Studio multicentrico, randomizzato, in doppio cieco, controllato con placebo, per gruppi paralleli, di fase 2a volto a valutare l’efficacia e la sicurezza di zabedosertib (BAY 1834845) per il trattamento di pazienti adulti affetti da dermatite atopica da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn how well the study treatment zabedosertib (BAY1834845) works and how safe it is compared to placebo in adult participants with moderate-to-severe atopic dermatitis
    Studio per verificare l'efficacia e la sicurezza del trattamento con zabedosertib (BAY1834845) rispetto al placebo in partecipanti adulti con dermatite atopica da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    Damask
    Damask
    A.4.1Sponsor's protocol code number22158
    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 SponsorBAYER AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointTherapeutic Area Head
    B.5.3 Address:
    B.5.3.1Street AddressKaiser-Wilhelm-Allee
    B.5.3.2Town/ cityLeverkusen
    B.5.3.3Post codeD-51368
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayer.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 nameBAY 1834845 coated tablet 120 mg
    D.3.2Product code [BAY 1834845 coated tablet 120 mg 123]
    D.3.4Pharmaceutical form 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 INNZabedosertib
    D.3.9.1CAS number 1931994-81-8
    D.3.9.2Current sponsor codeBAY 1834845 micronized
    D.3.9.4EV Substance CodeSUB221394
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCoated 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
    Atopic dermatitis
    dermatite atopica
    E.1.1.1Medical condition in easily understood language
    Long lasting inflammation of the skin, also called eczema, causing patches of skin to become swollen, red, cracked, and itchy
    Un'infiammazione duratura della pelle, detta anche eczema, che provoca chiazze di pelle gonfie, rosse, screpolate e pruriginose.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the efficacy of zabedosertib vs. placebo in adult patients with moderate-to-severe atopic dermatitis (AD) with inadequate response to topical corticosteroids or if topical treatments are medically not advisable.
    Valutare l'efficacia di zabedosertib rispetto al placebo in pazienti adulti affetti da dermatite atopica (DA) da moderata a grave con risposta inadeguata ai corticosteroidi per uso topico o laddove i trattamenti topici non siano consigliabili dal punto di vista clinico
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety and tolerability of zabedosertib vs. placebo.
    Valutare la sicurezza e la tollerabilità di zabedosertib rispetto al placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 to 65 years of age inclusive, at the time of signing the informed consent.
    2. Diagnosis of atopic dermatitis (AD) for = 1 year at the screening visit.
    3. Moderate-to-severe AD at randomization visit as defined by
    -- Eczema Area and Severity Index (EASI) score = 16,
    -- Body surface area (BSA) affected by AD = 10%,
    -- Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score = 3, and
    -- Peak Pruritus 0-10 numerical rating scale (NRS) = 4 (average score of the daily scores of the 7 days before randomization, with = 4 scores required).
    4. Documented history (within 6 months prior to the first screening visit) of inadequate response to treatment with topical corticosteroids (TCS), or if TCS are medically not advisable (e.g., due to important side effects or safety risks).
    5. Stable amount of emollient applied to skin over the whole body twice daily for at least the 7 consecutive days before the randomization visit
    6. Body mass index (BMI) within the range of 18.5 to 35.0 kg/m2 (inclusive) at screening (Visit 1) and randomization visits.
    7. Women of childbearing potential and male subjects able to father children must agree to use adequate contraception when sexually active.
    1. Età compresa fra i 18 e i 65 anni (estremi inclusi) al momento della firma del consenso informato.
    2. Diagnosi di DA da = 1 anno alla visita di screening.
    3. DA da moderata a grave alla visita di randomizzazione, definita mediante
    - Punteggio EASI = 16,
    - = 10% della superficie corporea interessata dalla DA,
    - Punteggio vIGA-AD = 3, e
    - Punteggio NRS relativo al prurito massimo (0-10) = 4 (media dei punteggi giornalieri dei 7 giorni precedenti alla randomizzazione, con punteggi necessariamente = 4).
    4. Storia documentata (nei 6 mesi precedenti alla prima visita di screening) di risposta inadeguata al trattamento con corticosteroidi per uso topico (TCS) o casi in cui i TCS siano sconsigliati per motivi medici (ad es., a causa di importanti effetti indesiderati o rischi di sicurezza).
    5. Applicazione di una quantità costante di emolliente sulla cute in tutto il corpo due volte al giorno per almeno i 7 giorni consecutivi precedenti alla visita di randomizzazione.
    6. Indice di massa corporea (IMC) compreso tra 18,5 e 35,0 kg/m2 (estremi inclusi) alle visite di screening (visita 1) e di randomizzazione.
    7. Le donne in età fertile e i soggetti maschi in grado di procreare devono acconsentire a utilizzare metodi contraccettivi adeguati durante l’attività sessuale. Questa restrizione si applica dalla firma del modulo di consenso informato fino a 30 giorni dopo l’ultima somministrazione dell’intervento in studio.
    8. Capacità di fornire il consenso informato firmato, che comprende l’aderenza ai requisiti e ai limiti riportati nel modulo di consenso informato (ICF) e nel presente protocollo.
    E.4Principal exclusion criteria
    1. History of any major surgery within 8 weeks prior to screening or scheduled (elective) surgery, planned hospitalization and/or planned dental treatment during the study that could constitute a risk when participating in a study.
    2. Severe invasive infections in medical history and/or active clinically significant viral, bacterial, fungal, or parasitic infection (systemic or severe skin infection) = 3 months prior to the randomization visit.
    3. A presence of uncontrolled condition including cardiovascular, respiratory, hepatic renal, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product, study conduct or could interfere with the interpretation of data.
    4. Known immunodeficiency disorder or immunocompromised state or, in the opinion of the investigator, unacceptable risk for participating in the study.
    5. Use of topical treatments for AD within 7 days before the randomization visit.
    6. Systemic immunosuppressive/ immunomodulating therapy or phototherapy within 4 weeks before the randomization visit.
    7. Therapy with biologic drugs within 5 half-lives of the biologic drug
    8. Known hypersensitivity to the study drug
    ¿ Qualsiasi intervento chirurgico importante nelle 8 settimane precedenti allo screening o intervento chirurgico (elettivo) pianificato, ricovero programmato e/o trattamento odontoiatrico programmato nel corso dello studio che possa costituire un rischio quando si partecipa a uno studio.
    ¿ Storia medica di gravi infezioni invasive e/o infezione attiva clinicamente significativa di natura virale, batterica, fungina o parassitaria (infezione sistemica o grave infezione della cute) nei 3 mesi precedenti alla visita di randomizzazione.
    ¿ Presenza di una condizione non controllata o di qualsiasi malattia instabile che, a giudizio dello sperimentatore, possa costituire un rischio quando si assume il prodotto sperimentale o durante lo svolgimento dello studio oppure possa interferire con l’interpretazione dei dati.
    ¿ Qualsiasi elemento anomalo clinicamente rilevante legato a una condizione medica o alla storia medica, oppure qualsiasi scostamento dalla norma di valori di laboratorio, esami fisici, segni vitali o ECG a 12 derivazioni, emerso allo screening o alla randomizzazione, che secondo lo sperimentatore possa comportare un rischio per il partecipante se questi prende parte allo studio oppure possa rendere difficoltosa l’interpretazione dei dati.
    ¿ Partecipanti con una qualsiasi di queste condizioni entro 12 settimane dall’arruolamento nello studio: infarto del miocardio, cardiopatia ischemica instabile o evento cerebrovascolare.
    ¿ Storia o presenza di disturbo linfoproliferativo oppure segni o sintomi che suggeriscano la possibile presenza di disturbo linfoproliferativo, compresa linfoadenopatia o splenomegalia; oppure malattia maligna attiva primaria o recidiva; oppure remissione da patologia maligna clinicamente significativa da < 5 anni.
    Le seguenti eccezioni relative a quanto specificato sopra sono accettabili per l’arruolamento:
    o carcinoma cervicale in situ rimosso mediante resezione senza alcuna evidenza di recidiva o malattia metastatica per = 3 anni e
    o tumori epiteliali squamosi o a cellule basali rimossi mediante resezione completa senza alcuna evidenza di recidiva per = 3 anni.
    ¿ Disturbo da immunodeficienza noto, stato di immunocompromissione o rischio inaccettabile (a discrezione dello sperimentatore) legato alla partecipazione allo studio.
    ¿ Utilizzo di antistaminici sistemici o per uso topico nei 7 giorni precedenti alla visita 3.
    ¿ Utilizzo di trattamenti topici per la DA (ovvero, glucocorticosteroidi topici [TCS], inibitori della calcineurina topici [TCI] o inibitori delle JAK topici) nei 7 giorni precedenti alla visita di randomizzazione.
    (....)
    Per problemi di spazio si rimanda alla SINOSSI PROTOCOLLO in ITALIANO per la lista completa dei Criteri Esclusione
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants having achievement of 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75 response) at Week 12 (Day 84)
    Riduzione del 75% rispetto al basale del punteggio EASI (risposta EASI 75) alla settimana 12 (giorno 84, EOT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    up to Week 12 (Day 84)
    Fino a settimana 12 (giorno 84)
    E.5.2Secondary end point(s)
    1. Percent change from baseline in EASI at Week 12 (Day 84)
    2. Number of participants having achievement of EASI 50 response at Week 12 (Day 84)
    3. Number of participants having achievement of EASI 90 response at Week 12 (Day 84)
    4. Number of participants having achievement of a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) response (score 0 or 1 and = 2 points improvement) at Week 12 (Day 84)
    5. Absolute change from baseline in body surface area (BSA) affected by atopic dermatitis (AD) at Week 12 (Day 84)
    6. Absolute values and percent change of weekly average of the Peak Pruritus 0-10 numerical rating scale (NRS) score from baseline at Week 12 (Day 84)
    7. Achievement of a = 4 point-improvement (reduction) in the weekly average of the Peak Pruritus 0-10 NRS score from baseline to Week 12 (Day 84) for participants with Peak Pruritus 0-10 NRS score = 4 at baseline
    8. Frequency and severity of treatment-emergent adverse events (TEAEs)
    1• Variazione percentuale dell’EASI dal basale alla settimana 12 (giorno 84)
    2• Risposta EASI 50 alla settimana 12 (giorno 84)
    3• Risposta EASI 90 alla settimana 12 (giorno 84)
    4• Risposta vIGA-AD (punteggio 0 o 1 e miglioramento =2 punti) alla settimana 12 (giorno 84)
    5• Variazione assoluta della superficie corporea (body surface area, BSA) interessata dalla DA dal basale alla settimana 12 (giorno 84)
    6• Valori assoluti e variazione percentuale della media settimanale del punteggio NRS relativo al prurito massimo (0-10) dal basale alla settimana 12 (giorno 84)
    7• Miglioramento (riduzione) di = 4 punti della media settimanale del punteggio NRS relativo al prurito massimo (0-10) dal basale alla settimana
    8• Frequenza e gravità degli eventi avversi associati al trattamento (TEAE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7: up to Week 12 (Day 84)
    8: up to 91 days
    1-7: fino a settimana 12 (giorno 84)
    8: fino a 91 giorni
    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) 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 EEA16
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Poland
    Czechia
    Germany
    Italy
    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
    The end of the study is defined as the date of the clean database.
    Chiusura database
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days25
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 48
    F.4.2.2In the whole clinical trial 72
    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)
    Participants who complete the treatment period or who are prematurely withdrawn from the study will not have further access to study intervention, and it will be up to the investigators discretion to provide follow-up medical care for all participants who complete the study or who are prematurely withdrawn from the study or refer them for appropriate ongoing care as required.
    I partecipanti che completano il periodo di trattamento o che si ritirano prematuramente dallo studio non avranno ulteriore accesso al farmaco in studio, e sarà a discrezione degli sperimentatori fornire assistenza medica di follow-up a tutti i partecipanti che completano lo studio o che si ritirano prematuramente dallo studio o indirizzarli per un'adeguata assistenza continua, come richiesto.
    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 Decision2022-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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