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    EudraCT Number:2020-002701-26
    Sponsor's Protocol Code Number:64304500CRD2002
    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:2021-04-07
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002701-26
    A.3Full title of the trial
    A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease
    Uno studio clinico di Fase 2a, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, multicentrico, di fattibilità (Proof-of-Concept), volto a valutare la sicurezza e l’efficacia di JNJ-64304500 come terapia aggiuntiva alla terapia biologica standard di cura con anti-fattore di necrosi tumorale alfa o anti-interleuchina 12/23 in partecipanti rispondenti non remittenti con malattia di Crohn attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the safety and effectiveness of JNJ-64304500 as an add-on therapy to standard of care biologic therapy with anti-tumor necrosis factor alpha or anti-interleukin 12/23 in responder not remitter participants with active Crohn's Disease
    Uno studio clinico per valutare la sicurezza e l'efficacia di JNJ-64304500 come terapia aggiuntiva alla terapia biologica standard di cura con fattore di necrosi antitumorale alfa o anti-interleuchina 12/23 in partecipanti responder non remitter con malattia di Crohn attiva
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number64304500CRD2002
    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 S.p.A.
    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 AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    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-64304500
    D.3.2Product code [JNJ-64304500]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNJNJ-64304500
    D.3.9.2Current sponsor codeJNJ-64304500
    D.3.9.3Other descriptive namesezione * D. - valore: 400mg alla settimana 0, in seguito 200mg ogni due settimane
    D.3.9.4EV Substance CodeSUB181366
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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. 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 Yes
    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 Yes
    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 Yes
    D. medicinal product typeanticorpo monoclonale
    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 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
    Active Crohn's Disease
    Malattia di Crohn attiva
    E.1.1.1Medical condition in easily understood language
    Active Crohn's Disease
    Malattia di Crohn attiva
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To evaluate safety and tolerability at Week 12
    2. To evaluate efficacy at Week 12 (change in Crohn's Disease Activity Index [CDAI] score from baseline)
    1. Valutare sicurezza e tollerabilità alla settimana 12;
    2. Valutare l'efficacia alla settimana 12 (variazione del punteggio dell'indice di attività della malattia di Crohn [CDAI] dal basale)
    E.2.2Secondary objectives of the trial
    1. To evaluate clinical response/remission at Week 12
    2. To evaluate pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD)/biomarkers at Week 12
    1. Valutare la risposta / remissione clinica alla settimana 12;
    2. Valutare farmacocinetica (PK), immunogenicità e farmacodinamica (PD) / biomarcatori alla settimana 12
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential participant must satisfy all of the following criteria to be enrolled in the study:
    1. male or female, 18 to 65 years old (inclusive).
    2. have confirmed clinical diagnosis of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration.
    3. initiated SOC biologic therapy
    - Adalimumab (including HUMIRA or an equivalent biosimilar which could include: HULIO, HYRIMOZ, IMRALDI, or AMGEVITA) at maintenance dose of 40 mg SC q2w
    - Ustekinumab at maintenance dose of 90 mg SC q8w
    4. have healthcare provider documentation of suboptimal response to SOC biologic therapy with no documented deterioration or clinical remission during current treatment.
    5. do not have clinically relevant immunogenicity to participant's current SOC biologic therapy at screening.

    Please refer to protocol for all inclusion criteria.
    Ogni potenziale partecipante deve soddisfare tutti i seguenti criteri per essere arruolato nello studio.
    1. sesso maschile o femminile da 18 a 65 anni di età (compresi).
    2. Aver ricevuto una diagnosi clinica confermata di malattia di Crohn o di malattia di Crohn fistolizzante da almeno 3 mesi.
    3. Aver iniziato la terapia biologica SOC
    - Adalimumab (incluso HUMIRA o un biosimilare equivalente che potrebbe includere: HULIO, HYRIMOZ, IMRALDI o AMGEVITA) alla dose di mantenimento di 40 mg SC q2w
    - Ustekinumab alla dose di mantenimento di 90 mg SC q8w
    4. Dispone della documentazione dell'operatore sanitario della risposta non ottimale alla terapia biologica SOC senza deterioramento documentato o remissione clinica durante il trattamento in corso.
    5. Non Avere immunogenicità clinicamente rilevante rispetto alla terapia biologica SOC attuale del partecipante allo screening.

    Fare riferimento al Protocolo per un elenco completo dei criteri di inclusione.
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:
    1. has complications of Crohn's disease that could confound the effect of treatment.
    2. currently has or is suspected to have abscess
    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, stoma or ostomy.
    5. has had a central line within 12 weeks before first dose

    Please refer to protocol for all the exclusion criteria.
    Ogni potenziale partecipante che soddisfi uno dei seguenti criteri sarà escluso dalla partecipazione allo studio:
    1. Presenza di complicanze della malattia di Crohn che potrebbe confondere la capacità di valutare l’effetto del trattamento con JNJ-64304500.
    2. Avere o si sospetta abbia un ascesso.
    3. Aver avuto un qualsiasi tipo di resezione intestinale entro 6 mesi o qualsiasi altro intervento chirurgico intra-addominale nei 3 mesi precedenti al basale.
    4. Avere uno stoma o una stomia drenante (ovvero, funzionante).
    5. Aver inserito un catetere centrale nelle 12 settimane precedenti la prima dose.

    Fare riferimento al Protocolo per un elenco completo dei criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    1. Descriptive analyses of adverse events (AEs), clinical laboratory tests, and vital signs at Week 12 and applicable visits from Week 0 through Week 26
    2. Change from baseline in the CDAI score at Week 12.
    1. Analisi descrittive degli eventi avversi (EA), dei test clinici di laboratorio e dei segni vitali alla Settimana 12 e alle visite pertinenti dalla Settimana 0 alla Settimana 26;
    2. Variazione rispetto al basale del punteggio CDAI alla Settimana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Throughout the study
    2. Week 12
    1. Durante lo studio
    2. alla Settimana 12
    E.5.2Secondary end point(s)
    1. Analyses of the following at Week 12:
    - Proportion of participants achieving a clinical response.
    - Proportion of participants achieving a clinical remission.
    - Change in the simple endoscopic score for Crohn's disease (SES-CD) from baseline.
    - Proportion of participants achieving an endoscopic response
    - Proportion of participants achieving an endoscopic remission
    - Change in abdominal pain (AP) from baseline at all postbaseline visits
    - Proportion of participants achieving a Patient-Reported Outcome (PRO)-2 remission
    2. Analyses of the following at all applicable visits from Week 0 through Week 26:
    - Serum concentrations of investigational drug
    - Incidence and titers of antibodies to investigational drug.
    - Incidence of neutralizing antibodies to investigational drug.
    - Change in PD biomarker levels.
    1. Analisi dei seguenti alla Settimana 12:
    • percentuale di partecipanti che ottengono una risposta clinica
    • Percentuale di partecipanti che ottengono una remissione clinica
    • Variazione del punteggio endoscopico semplificato per la malattia di Crohn (SES-CD) rispetto al basale.
    • Percentuale di partecipanti che ottengono una risposta endoscopica
    • Percentuale di partecipanti che ottengono una remissione endoscopica
    • Variazione del dolore addominale (Abdominal Pain, AP) dal basale a tutte le visite
    • Percentuale di partecipanti che ottengono una remissione degli esiti riferiti dal paziente (PRO)-2
    2. Analisi dei seguenti in tutte le visite pertinenti dalla Settimana 0 fino alla Settimana 26:
    • Concentrazioni sieriche del farmaco sperimentale
    • Incidenza e titoli degli anticorpi anti-JNJ-64304500.
    • Incidenza di anticorpi neutralizzanti anti-JNJ-64304500.
    • Variazione dei livelli dei biomarcatori PD
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at Week 12
    2. Week 0 through Week 26
    1. Alla settimana 12
    2. Dalla settimana 0 alla settimana 26
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, biomarker evaluations, tolerability and medical resource utilization
    Immunogenicità, valutazioni di biomarcatori, tollerabilità e utilizzo delle risorse mediche
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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
    Ultima Vista dell'Ultimo soggetto in Studio (LVLS)
    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 months8
    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 months0
    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: 63
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 Yes
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 70
    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)
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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