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    EudraCT Number:2019-003335-37
    Sponsor's Protocol Code Number:67864238PACRD2001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003335-37
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Platform Study Evaluating the Efficacy and Safety of Interventions in Participants with Moderately to Severely Active Crohn’s Disease: Intervention JNJ-67864238
    Uno studio di tipo platform di fase 2, multicentrico, randomizzato, in doppio cieco, controllato con placebo per valutare l’efficacia e la sicurezza di trattamenti nei partecipanti affetti da malattia di Crohn attiva di grado da moderato a severo: Intervento JNJ-67864238
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to learn about the efficacy and safety of JNJ-67864238 in participants with Crohn's disease.
    Uno studio per valutare l'efficacia e la sicurezza di JNJ-67864238 in partecipanti affetti da malattia di Crohn
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number67864238PACRD2001
    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.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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportJanssen-Cilag SpA
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group - Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    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 nameJNJ-67864238
    D.3.2Product code [JNJ-67864238]
    D.3.4Pharmaceutical form Lozenge
    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.3.9.1CAS number 1865711-20-1
    D.3.9.2Current sponsor codeJNJ-67864238
    D.3.9.4EV Substance CodeSUB198982
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 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
    Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.
    Trattamento della malattia di Crohn attiva di grado da moderato a severo con JNJ-67864238.
    E.1.1.1Medical condition in easily understood language
    Treatment of moderately to severely active Crohn’s disease with JNJ-67864238.
    Partecipanti affetti da malattia di Crohn attiva di grado da moderato a severo
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10021425
    E.1.2Term Immune system disorder
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    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 evaluate the efficacy of JNJ-67864238 as measured by the change in the Crohn’s Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn’s disease (SES-CD) from baseline at Week 12.
    L’obiettivo primario è valutare l’efficacia di JNJ-principio attivo così come misurato dalla variazione del punteggio dell’indice di attività della malattia di Crohn (CDAI) dal basale alla Settimana 12.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of JNJ-67864238 in participants with moderately to severely active Crohn’s disease.
    To evaluate the efficacy of JNJ-67864238 to induce clinical remission, clinical response, and endoscopic healing of the mucosa.
    To evaluate the pharmacokinetics, pharmacodynamics, immunogenicity, and biomarker response of JNJ-67864238.
    I principali obiettivi secondari sono i seguenti:
    • Indagare la sicurezza e la tollerabilità di JNJ-principio attivo nei partecipanti affetti da malattia di Crohn attiva di grado da moderato a severo.
    • Valutare l’efficacia di JNJ-principio attivo al fine di ridurre il punteggio endoscopico semplice per la Malattia di Crohn (SES-CD), indurre la remissione clinica, la risposta clinica e la guarigione endoscopica della mucosa.
    • Valutare farmacocinetica, farmacodinamica, immunogenicità e la risposta dei biomarcatori di JNJ-principio attivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female
    2. 18 to 75 years of age, inclusive Disease Characteristics
    3. Have Crohn’s disease or fistulizing Crohn’s disease of at least 3 months’ duration, with colitis, ileitis, or ileocolitis confirmed at any time in the past by radiography, histology, and/or endoscopy
    4. Have active Crohn’s disease, defined as a baseline CDAI score of major or equal to 220 and minor or equal 450
    5. Have evidence of active ileocolonic Crohn’s disease as assessed by:
    a. An SES-CD score major or equal to 3 at screening by central endoscopy reading
    b. An elevated screening CRP (>0.3 mg/dL or 3.0 mg/L) or an elevated screening fecal calprotectin (>250 ug/mg)
    1. Sesso maschile o femminile
    2. Età compresa tra 18 e 75 anni, inclusi
    3. Malattia di Crohn o malattia di Crohn fistolizzante che si protrae da almeno 3 mesi con colite, ileite o ileocolite, confermata in precedenza da radiografia, esame istologico e/o endoscopia
    4. Malattia di Crohn attiva, definita come punteggio CDAI al basale maggiore o uguale a 220 e inferiore o uguale a 450
    5. Evidenza di malattia di Crohn ileocolica attiva valutata come indicato di seguito:
    a. Punteggio SES-CD maggiore o uguale a 3 allo screening stabilito con lettura centrale endoscopica.
    b. Un livello elevato di CRP (>0,3 mg/dL o 3,0 mg/L) allo screening o un livello elevato di calprotectina fecale (>250 µg /mg) allo screening
    E.4Principal exclusion criteria
    1.Has complications of Crohn’s disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with JNJ-67864238
    2.Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified
    3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
    4. Has a draining (ie, functioning) stoma or ostomy
    5. Has received any of the following prescribed medications or therapies within the specified period:
    a. Intravenous corticosteroids - Exclusionary Period <3 weeks before baseline
    b. Oral immunomodulatory agents including 6-thioguanine (6-TG), cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil, tofacitinib and other Janus kinase (JAK) inhibitors - Exclusionary Period <6 weeks or within 5 half-lives of agent before baseline, whichever is longer
    c. Natalizumab or biologic agents that deplete B or T cells (eg, rituximab or alemtuzumab) - Exclusionary Period <12 weeks before baseline
    1. Complicazioni di malattia di Crohn quali tratti ristretti o stenosi sintomatici, sindrome dell'intestino corto o qualsiasi altra manifestazione che potrebbe lasciar supporre la necessità di un intervento chirurgico, precludere l'utilizzo dell'Indice di attività della malattia di Crohn per la valutazione della risposta alla terapia o confondere potenzialmente la capacità di valutazione dell'effetto del trattamento con JNJ-principio attivo
    2. Ascesso sospetto o in corso. Ascessi cutanei e perianali recenti non costituiscono criterio di esclusione se drenati e adeguatamente trattati almeno 3 settimane prima del basale, o 8 settimane prima del basale nel caso di ascessi intra-addominali, purché non si supponga la necessità di ulteriori interventi chirurgici. I partecipanti con fistole attive possono essere inclusi qualora non si ipotizzi alcuna necessità di intervenire chirurgicamente e non siano stati identificati ascessi in corso
    3. Qualsiasi tipo di resezione intestinale avvenuta entro i 6 mesi precedenti al basale o altro intervento intra-addominale entro i 3 mesi precedenti al basale.
    4. Presenza di stoma o ostomia drenante (ad es., funzionante)
    5. Precedente somministrazione di qualsiasi dei seguenti farmaci o terapie prescritti entro il periodo specificato:
    a. Corticosteroidi per via endovenosa - Periodo di esclusione <3 settimane prima del basale
    b. Agenti immunomodulatori per via orale compresa 6-tioguanina (6-TG), ciclosporina, tacrolimus, sirolimus o mofetil micofenolato, tofacitinib e agli inibitori della Janus chinasi (JAK) - Periodo di esclusione <6 settimane o entro le 5 semivite di un agente precedentemente al basale, a seconda di quale sia il periodo più lungo
    c. Natalizumab o agenti biologici che riducono le cellule B o T (ad es. rituximab o alemtuzumab) Periodo di esclusione <12 settimane prima del basale
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline in the CDAI score at Week 12.
    L’endpoint primario è la variazione dal basale del punteggio CDAI alla Settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 Weeks
    12 settimane
    E.5.2Secondary end point(s)
    1. Change in the SES-CD from baseline
    2. Clinical response as measured by CDAI (=100-point reduction from baseline in CDAI or CDAI <150)
    3. Clinical remission rate as measured by CDAI (CDAI <150)
    4. PRO-2 remission defined as abdominal pain (AP) mean daily score (AP component of the CDAI) at or below 1 AND stool frequency (SF) mean daily score at or below 3, ie, AP =1 and SF =3
    5. Endoscopic response defined as at least a 50% improvement from baseline in the SES-CD
    6. Endoscopic remission defined as an SES-CD score =2
    I principali endpoint secondari includono le seguenti misurazioni alla Settimana 12:
    1. Variazione del SES-CD dal basale
    2. Risposta clinica misurata dal CDAI (riduzione di = 100 punti dal basale in CDAI o CDAI <150)
    3. Tasso di remissione clinica misurata secondo CDAI (CDAI <150)
    4. Remissione per esito riferito dal paziente (PRO)-2 definita come punteggio medio giornaliero (componente AP del CDAI) del dolore addominale (AP) pari o inferiore a 1 E punteggio medio giornaliero di frequenza di evacuazione (SF) pari o inferiore a 3, ossia AP =1 e SF = 3
    5. Risposta endoscopica definita come un aumento di almeno il 50% del SES-CD dal basale
    6. Remissione endoscopica definita come punteggio SES-CD = 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 Weeks
    12 settimane
    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 Yes
    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. 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 No
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Russian Federation
    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
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 80
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 47
    F.4.2.2In the whole clinical trial 90
    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 will be instructed that study intervention will not be made available to them after they have completed/discontinued the study intervention and that they should return to their primary physician to determine standard of care.
    I partecipanti saranno informati che il trattamento di studio non sarà reso disponibile a loro dopo che avranno completato/interrotto prematuramento lo studio e che dovranno riferirsi al loro medico di riferimento per determinare il trattamento a loro più opportuno.
    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 Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-11-03
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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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