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    Summary
    EudraCT Number:2016-000634-21
    Sponsor's Protocol Code Number:64304500CRD2001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-08
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-000634-21
    A.3Full title of the trial
    A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease
    Étude multicentrique de Phase 2b, randomisée, en double insu, contrôlée contre placebo, à groupes parallèles, destinée à évaluer l'efficacité et la tolérance de JNJ-64304500 chez des patients atteints d’une maladie de Crohn active d’intensité modérée à sévère
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s Disease
    Étude en double insu, contrôlée contre placebo destinée à évaluer
    l'efficacité et la tolérance de JNJ-64304500 chez des patients atteints
    d'une maladie de Crohn active d'intensité modérée à sévère
    A.4.1Sponsor's protocol code number64304500CRD2001
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International LLC
    B.5.2Functional name of contact point
    B.5.6E-mailclinicaltrial.enquiries@parexel.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 JNJ-64304500
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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.3.9.2Current sponsor codeJNJ-64304500
    D.3.9.3Other descriptive nameJNJ-64304500-AAA
    D.3.9.4EV Substance CodeSUB181366
    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 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 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.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International N.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUstekinumab
    D.3.2Product code CNTO1275
    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 INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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.3.11.13.1Other medicinal product typeMonoclonal Antibody
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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
    D.8 Placebo: 2
    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: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    maladie de Crohn active
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease (IBD)
    Maladie inflammatoire chronique de l'intestin (MICI)
    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 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
    - To evaluate the efficacy of JNJ-64304500 to reduce the CDAI score from baseline.
    - To evaluate the safety of JNJ-64304500.
    - Évaluer l'efficacité de JNJ-64304500 pour diminuer le score CDAI par rapport aux valeurs initiales.
    - Évaluer la tolérance de JNJ-64304500
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy of JNJ-64304500 to induce clinical remission, clinical response, and endoscopic healing of the mucosa, and to maintain remission
    - To evaluate the relationship between efficacy and the presence of the NKG2D and/or MICB SNP biomarkers.
    - To evaluate the efficacy of JNJ-64304500 to improve general and disease-specific healthrelated quality of life and to reduce Crohn’s disease-related hospitalizations and surgeries.
    - To evaluate the pharmacokinetics, immunogenicity, pharmacodynamics, and biomarkers (eg, reductions in CRP, fecal calprotectin, and fecal lactoferrin) of JNJ-64304500 therapy.
    - Évaluer l'efficacité de JNJ-64304500 pour induire une rémission clinique, une réponse clinique et une cicatrisation endoscopique de la muqueuse, et maintenir la rémission.
    - Évaluer la relation entre l'efficacité et la présence de NKG2D et/ou de biomarqueurs SNP MICB.
    - Évaluer l'efficacité de JNJ-64304500 pour améliorer la qualité de vie liée à la santé, générale et spécifique à la maladie, et diminuer le nombre d'hospitalisations et les interventions chirurgicales liées à la maladie de Crohn.
    - Évaluer la pharmacocinétique, l'immunogénicité, la pharmacodynamique et les biomarqueurs (par exemple, diminutions de la CRP, mesure de la calprotectine et de lactoferrine dans les selles) du
    traitement par JNJ-64304500.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 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.
    - Have active Crohn’s disease, defined as a baseline CDAI score of ≥220 but ≤450.
    Have at least one of the following at screening: An abnormal CRP (>0.3 mg/dL [>3.0 mg/L]) OR Calprotectin >250 mg/kg.
    Study 1: Has previously demonstrated inadequate response, loss of response, or intolerance to 1 or more approved biologic therapies
    Study 2: Has failed conventional therapy (currently receiving corticosteroids and/or immunomodulators OR has a history of failure to respond to or tolerate an adequate course of corticosteroids and/or immunomodulators OR is corticosteroid dependent or has had a history of corticosteroid dependency).
    Part II: Has previously demonstrated inadequate response, loss of response, or intolerance to 1 or more approved biologic therapies or has failed conventional therapy.
    All 3 Studies:
    - Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease, which are permitted provided that doses meeting these requirements are stable, or have been discontinued, for at least 3 weeks before baseline (Week 0), unless otherwise specified:
    a. Oral 5-aminosalicylic acid (5-ASA) compounds.
    b. Oral corticosteroids at a prednisone-equivalent dose at or below 40 mg/day, or 9 mg/day of budesonide, or 5 mg/day beclomethasone dipropionate.
    c. Antibiotics being used as a primary treatment of Crohn's disease.
    d. Conventional immunomodulators (ie, AZA, 6-MP, or MTX): subjects must have been taking them for at least 12 weeks and at a stable dose for at least 4 weeks before baseline.
    - A subject with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance
    - A subject who has had extensive colitis for ≥8 years, or disease limited to the left side of the colon for ≥12 years, must either have had a colonoscopy to assess for the presence of dysplasia within 1 year before the first administration of study agent or a colonoscopy to assess for the presence of malignancy at the screening visit, with no evidence of malignancy.
    - Have screening laboratory test results within the following parameters:
    a. Hemoglobin ≥8.0 g/dL.
    b. White blood cell count (WBCs) ≥3.0 × 103/μL.
    c. Neutrophils ≥1.5 × 103/μL.
    d. Platelets ≥100 × 103/μL.
    e. Serum creatinine <1.7 mg/dL.
    f. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations must be within 2 times the upper limit of the normal range (ULN) range for the laboratory conducting the test.
    g. Direct (conjugated) bilirubin <1.0 mg/dL.
    - Are considered eligible according to the following tuberculosis (TB) screening criteria (see details in protocol):
    a. Have no history of latent or active TB before screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB before or simultaneously with the first administration of study agent.
    d. Within 2 months before the first administration of study agent, either have negative QuantiFERON-TB Gold test (Attachment 2), or have a newly identified positive QuantiFERON-TB Gold test in which active TB has been ruled out, and for which appropriate treatment for latent TB has been initiated either before or simultaneously with the first administration of study agent
    e. Have a chest radiograph (posterior-anterior and lateral views), taken within 3 month before the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.
    - A woman of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin [β-hCG]) pregnancy test result at screening and a negative urine pregnancy test result at Week 0.
    - Before randomization, a female subject must be either:
    a. Not of childbearing potential or
    b. Of childbearing potential and:
    1) Practicing a highly effective method of contraception (failure rate of <1% per year when used consistently and correctly), consistent with local regulations regarding the use of contraceptive methods for subjects participating in clinical studies. If using a hormone birth control method, a second method of birth control, such as a condom or
    diaphragm, must be used.
    2) Agrees to remain on a highly effective method of contraception throughout the study and for at least 16 weeks after the last administration of study agent.
    - Maladie de Crohn fistulisante ou non, depuis au moins 3 mois, avec colite, iléite ou iléocolite, confirmée précédemment par une radiographie, quelle que soit sa date de réalisation, une histologie et/ou une endoscopie.
    -Maladie de Crohn active, définie par un score CDAI initial ≥220 mais ≤ 450.
    -Présence d'au moins un des critères suivants lors de la sélection :CRP anormale (> 0,3 mg/dl [> 3,0 mg/l]) OUCalprotectine > 250 mg/kg.
    l’étude 1: Antécédents de réponse insuffisante, perte de réponse ou intolérance à 1 ou plusieurs traitements biologiques approuvés
    l’étude 2: Antécédent d'échec du traitement classique
    Partie II: les patients doivent satisfaire à l'exigence suivante relative aux traitements antérieurs ou en cours pour la maladie de Crohn : antécédents de réponse insuffisante, perte de réponse ou intolérance à 1 ou plusieurs traitements biologiques approuvés OU Antécédent d'échec du traitement classique.
    All 3 Studies:
    - Respect des exigences relatives aux traitements concomitants dans la maladie de Crohn, qui sont autorisés, à condition que les doses respectant ces exigences soient stables, ou qu'ils aient été arrêtés depuis au moins 3 semaines avant l'inclusion (Semaine 0), sauf mention contraire:
    -Chez un patient ayant des antécédents familiaux de cancer colorectal ou des antécédents personnels augmentant le risque de cancer colorectal, un patient âgé de > 50 ans ou présentant un autre facteur de risque connu.
    - Chez un patient présentant une colite extensive depuis ≥ 8 ans ou une atteinte limitée au côté gauche du côlon depuis ≥ 12 ans, réalisation d'une coloscopie pour évaluer la présence d'une dysplasie dans l'année précédant la première administration du médicament à l'étude ou réalisation d'une coloscopie pour évaluer la présence d'un cancer lors de la visite de sélection, sans mise en évidence de malignité.
    -Résultats des analyses biologiques dans les valeurs suivantes :
    Hémoglobine ≥ 8,0 g/dl ; globules blancs (GB) ≥ 3,0 x 103/μl ; neutrophiles ≥ 1,5 x 103/μl ; plaquettes ≥100 x 103/μl ; créatininémie < 1,7 mg/dl ; les taux d'alanine aminotransférase (ALAT) et d'aspartate aminotransférase (ASAT) doivent être compris dans une fourchette de valeurs correspondant à 2 fois la limite supérieure à la normale (LSN) pour le laboratoire effectuant les analyses ; bilirubine directe (conjuguée) < 1,0 mg/dl.
    -Considérés comme éligibles selon les critères de dépistage de la tuberculose (TB)
    -Femmes en âge de procréer : résultat négatif du test sanguin de grossesse hautement sensible (dosage du taux de gonadotrophines chorioniques humaines β [β-hCG]) lors de la période de sélection et résultat négatif du test urinaire de grossesse à la Semaine 0.
    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, or would possibly confound the ability to assess the effect of treatment with JNJ-64304500 or ustekinumab.
    2. Currently has or is suspected to have an abscess (see details in protocol).
    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. IV corticosteroids <3 weeks before baseline.
    b. Other oral immunomodulatory agents (eg, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil, tofacitinib and other Janus kinase [JAK] inhibitors) <6 weeks or within 5 half-lives of agent before baseline, whichever is longer.
    c. Nonbiologic experimental or investigational agents <4 weeks or within 5 half-lives of agent before baseline, whichever is longer.
    d. Nonautologous stem cell therapy (eg, Prochymal), natalizumab, efalizumab, or biologic agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) <12 months before baseline.
    e. TNFα-antagonist biologic agents (eg, mAb therapies) or other agents intended to suppress or eliminate TNFα <8 weeks before baseline.
    f. Vedolizumab <16 weeks before baseline.
    g. Other immunomodulatory biologic agents <12 weeks or within 5 half-lives of agent before baseline, whichever is longer.
    h. Treatment with apheresis (eg, Adacolumn apheresis) or total parenteral nutrition as a treatment for Crohn’s disease <3 weeks before baseline.
    6. Has a stool culture or other examination positive for an enteric pathogen in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
    7. Has previously received a biologic agent targeting IL-12 or IL-23.
    8. Has previously received JNJ-64304500 or NNC0142-002.
    9. Has received a Bacille Calmette-Guérin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks before baseline.
    10. Has a history of, or ongoing, chronic or recurrent infectious disease.
    11. Has current signs or symptoms of infection. Established nonserious infections (eg, acute upper respiratory tract infection, simple urinary tract infection) need not be considered exclusionary at the discretion of the investigator.
    12. Has a history of serious infection (eg, sepsis, pneumonia, or pyelonephritis) for 8 weeks before baseline.
    13. Has evidence of a Herpes zoster infection ≤8 weeks before baseline.
    14. Has a history of latent or active granulomatous infection before screening.
    15. Has evidence of current active infection, including TB, or a nodule suspicious for lung malignancy on screening or any other available chest radiograph.
    16. Has or ever has had a nontuberculous mycobacterial infection or serious opportunistic infection.
    17. Has a history of HIV antibody positivity, or tests positive for HIV at screening.
    18. Are seropositive for antibodies to HCV without a history of successful treatment.
    19. Subjects must undergo screening for HBV:
    a. Subjects who test negative for all HBV screening tests (ie, HBsAg-, anti-HBc-, and anti-HBs-) are eligible for this study.
    b. Subjects who test positive for surface antigen (HBsAg+) are not eligible for this study, regardless of the results of other hepatitis B tests.
    c. Subjects who test negative for surface antigen (HBsAg-) and test positive for core antibody (anti-HBc+) and surface antibody (anti-HBs+) are eligible for this study.
    d. Subjects who test positive only for surface antibody (anti-HBs+) are eligible for this study.
    e. Subjects who test positive only for core antibody (anti-HBc+) must undergo further testing for hepatitis B DNA acid (HBV DNA test). If the HBV DNA test is positive, the subject is not eligible for this study. If the HBV DNA test is negative, the subject is eligible for this study. In the event the HBV DNA test cannot be performed, the subject is not eligible for this study.
    20. Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
    21. Has a transplanted organ (with exception of a corneal transplant >12 weeks before screening).
    22. Has a known history of lymphoproliferative disease, including monoclonal gammopathy of unknown significance (MGUS), lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
    23. Has any known malignancy or has a history of malignancy.
    24. Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
    - Complications de la maladie de Crohn, comme des sténoses symptomatiques, un syndrome de l'intestin court, ou toute autre manifestation pouvant être susceptible de nécessiter une intervention chirurgicale, pouvant empêcher l'utilisation du score CDAI pour évaluer la réponse au traitement, ou pouvant constituer un facteur de confusion possible pour l'évaluation de l'effet du traitement par JNJ-64304500 ou ustekinumab
    -Présence suspectée ou avérée d'un abcès en cours
    -Antécédents de résection intestinale dans les 6 mois précédents ou antécédents de toute autre intervention intra-abdominale dans les 3 mois précédant l'inclusion
    -Stomie drainante (c'est-à-dire fonctionnant)
    -Médicaments ou traitements antérieurs suivants pendant la période spécifiée:
    a.Corticoïdes IV < 3 semaines avant l'inclusion
    b.autres agents immunomodulateurs oraux < 6 semaines ou dans les 5 demi-vies de l'agent avant l'inclusion, en fonction de la période la plus longue
    c.agents non biologiques expérimentaux ou à l'étude < 4 semaines ou dans les 5 demi-vies de l'agent avant l'inclusion, en fonction de la période la plus longue
    d.traitement par cellules souches non autologues ou agents biologiques supprimant les lymphocytes T ou B < 12 mois avant l'inclusion
    e.agents biologiques antagonistes du TNFα ou autres agents destinés à inhiber ou éliminer le TNFα < 8 semaines avant l'inclusion
    f.traitement par vedolizumab < 16 semaines avant l'inclusion
    g.autres agents biologiques immunomodulateurs < 12 semaines ou dans les 5 demi-vies de l'agent avant l'inclusion, en fonction de la période la plus longue
    h.traitement par aphérèse ou nutrition parentérale totale dans le cadre de la maladie de Crohn < 3 semaines avant l'inclusion
    6)Coproculture ou autre examen positif pour la recherche d'agent pathogène intestinal, y compris de la toxine de Clostridium difficile, au cours des 4 mois précédents au moins, sauf si un deuxième examen est négatif et qu'il n'y a pas de signes d'infection en cours avec l'agent pathogène en question
    7) Traitement antérieur par un agent biologique ciblant IL-12 ou IL-23
    8) Antécédents de traitement par JNJ-64304500 ou NNC0142-002.
    9) Vaccination antérieure par Bacille Calmette-Guérin (BCG) dans les 12 mois ou tout autre vaccin bactérien ou viral vivant dans les 12 semaines avant l'inclusion.
    10) Antécédents ou présence en cours de maladie infectieuse chronique ou récurrente
    11) Signes ou symptômes d'infection en cours.
    12) Antécédents d'infection grave
    13) Présence d'une infection à herpès zoster ≤8 semaines avant l'inclusion.
    14) Présence d'une d'infection granulomateuse latente ou active avant l'inclusion
    15) Pathologie rénale, hépatique, hématologique, endocrinienne, pulmonaire, cardiaque, neurologique, cérébrale ou psychiatrique sévère, progressive ou incontrôlée, ou signes et symptômes de ce type de maladie.
    16) Greffe d'organe
    17) Antécédents connus de maladie lymphoproliférative.
    18) séropositifs pour les anticorps anti-VHC sans antécédents de traitement satisfaisant
    19) doivent subir un dépistage du VHB
    20) une maladie rénale, hépatique, hématologique, endocrinienne, pulmonaire, cardiaque, neurologique, cérébrale ou psychiatrique grave, progressive ou non contrôlée, ou des signes et des symptômes de celle-ci.
    Cf protocole
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in the CDAI score at Week 8.
    modifications du score CDAI à la Semaine 8
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 8
    semaine 8
    E.5.2Secondary end point(s)
    The following endpoints will be evaluated as major secondary endpoints only in Part II (the dose-ranging portion of the study); these endpoints will be evaluated in Part I, but are not specified as major secondary endpoints.
    1. Clinical remission at Week 8 as measured by CDAI (CDAI <150).
    2. Clinical response at Week 8 as measured by CDAI (≥100-point reduction from baseline in CDAI or CDAI <150).
    3. Change in PRO-2 (the sum of the abdominal pain and stool frequency subscores of the CDAI score) from baseline at Week 8.
    4. Change in abdominal pain score (mean daily average based on the CDAI assessment) from baseline at all postbaseline visits.
    5. Change in stool frequency score (mean daily average based on the CDAI assessment) from baseline at all postbaseline visits.
    6. Clinical remission at Week 8 as measured by PRO-2 (PRO-2 <75).
    7. Clinical response at Week 8 as measured by PRO-2 (≥50-point reduction from baseline in PRO-2 or PRO-2 <75).
    8. Change in Simple Endoscopic Score for Crohn's Disease (SES-CD) from baseline at Week 12.

    The following efficacy endpoints will be evaluated in Part I and Part II:
    9. Change in CDAI from baseline at all postbaseline visits.
    10. Clinical remission based on CDAI at all postbaseline visits.
    11. Clinical response based on CDAI at all postbaseline visits.
    12. Change in PRO-2 from baseline at all postbaseline visits.
    13. Clinical remission based on PRO-2 at all postbaseline visits.
    14. Clinical response based on PRO-2 at all postbaseline visits.
    15. Change in PRO-3 (the sum of abdominal pain, stool frequency, and general well-being subscores of the CDAI score) from baseline at all postbaseline visits.
    16. Clinical remission based on CDAI at Week 24 among subjects in clinical response at Week 8.
    17. Clinical remission based on CDAI at Week 24 among subjects in clinical remission at Week 8.
    For further endpoints see protocol.
    Les critères d'évaluation suivants seront uniquement considérés comme
    des critères secondaires
    majeurs dans l'Étude 3 (la partie de recherche de doses de l'étude) ; ces
    critères seront évalués dans l'Étude 1 et l'Étude 2 mais ne sont pas
    considérés comme étant des critères d'évaluation secondaires majeurs
    pour ces études.
    1. Rémission clinique à la Semaine 8, mesurée par le score CDAI (CDAI <
    150).
    2. Réponse clinique à la Semaine 8 mesuré par le score CDAI (diminution
    100 points du score CDAI par rapport aux valeurs initiales ou CDAI <
    150).
    3. Modification de PRO-2 (somme des sous-scores CDAI de douleur
    abdominale et de fréquence des selles) à la Semaine 8 par rapport aux
    valeurs initiales.
    4.Echelle numérique (EN) d'évaluation de la douleur abdominale
    5.Évaluation des selles sur l'échelle de Bristol
    6. Rémission clinique à la Semaine 8, mesurée par le score PRO-2 (PRO-
    2 < 75).
    7. Réponse clinique à la Semaine 8 mesuré par le score PRO-2
    (diminution ≥ 50 points du score PRO-2 par rapport aux valeurs initiales
    ou PRO-2 < 75).
    8. Modification du score endoscopique simple pour la maladie de Crohn
    (SES-CD, Simple Endoscopic Score for Crohn's Disease) à la Semaine 12.
    Les évaluations de l'efficacité seront les suivantes:
    9.modification moyenne du score CDAI par rapport aux valeurs initiales
    10. Rémission clinique , mesurée par le score CDAI
    11.Réponse clinique mesuré par le score CDAI
    12.Modification de PRO-2 par rapport aux valeurs initiales.
    13.Rémission clinique , mesurée par le score PRO-2
    14.Réponse clinique mesuré par le score PRO-2
    15.Modification de PRO-3 par rapport aux valeurs initiales.
    16.Rémission clinique à la Semaine 24, mesurée par le score CDAI,
    parmis les patients avec la réponse clinique à la Semaine 8
    17. Rémission clinique à la Semaine 24, mesurée par le score CDAI,
    parmis les patients avec la rémission clinique à la Semaine 8
    cf protocole
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints 1. - 5.: At week 8
    Endpoint 6.: At week 12
    Endpoints 7. - 15.: At all postbaseline visits
    Endpoints 16.-17.: At week 24
    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 Yes
    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
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial7
    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 EEA99
    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
    Belgium
    Bulgaria
    Canada
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Ukraine
    United Kingdom
    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
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 679
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 404
    F.4.2.2In the whole clinical trial 693
    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)
    Patients who end their participation in the trial will return to the standard therapy according to their health care scheme.
    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 Decision2019-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
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