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    Summary
    EudraCT Number:2019-004225-24
    Sponsor's Protocol Code Number:CNTO1275CRD3004
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-11-20
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2019-004225-24
    A.3Full title of the trial
    A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    UNITI-Jr
    A.4.1Sponsor's protocol code numberCNTO1275CRD3004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/321/2020
    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, LLC
    B.4.2CountryUnited States
    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
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 Yes
    D.2.1.1.1Trade name STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 Concentrate for 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.3.9.2Current sponsor codeCNTO1275
    D.3.9.3Other descriptive nameUSTEKINUMAB
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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
    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.3.9.2Current sponsor codeCNTO1275
    D.3.9.3Other descriptive nameUSTEKINUMAB
    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 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 Yes
    D.2.1.1.1Trade name STELARA®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.9.2Current sponsor codeCNTO1275
    D.3.9.3Other descriptive nameUSTEKINUMAB
    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 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.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 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
    Moderately to Severely Active Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    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
    Global:
    1. To evaluate the efficacy of ustekinumab dosing in inducing clinical remission in pediatric participants with moderately to severely Crohn's disease
    2. To evaluate the safety profile of ustekinumab in pediatric participants with moderately to severely active Crohn's disease.
    3. To evaluate ustekinumab exposure (PK).

    US specific:
    4. To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction.
    5. To evaluate the safety profile of ustekinumab.
    6. To evaluate ustekinumab exposure (pharmacokinetics [PK]).
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of IV ustekinumab during the induction period.
    2. To evaluate the efficacy of SC ustekinumab during the maintenance period among participants who were in clinical response in induction.
    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:

    General
    1. 2 to <18 years of age, inclusive (at the time of the first administration of study intervention at Week I-0) with a body weight ≥10 kg.
    2. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator.
    3. Criterion modified per Amendment 2
    3.1 Medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and acknowledged by the investigator.

    Crohn's Disease diagnosis and status
    4. Have Crohn's disease or fistulizing Crohn's disease of at least 3 months duration, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology.
    5. Must have moderately to severely active Crohn's disease (as defined by a baseline PCDAI score >30) AND at least one of the following:
    a. An abnormal CRP (>0.3 mg/dL or 3.0 mg/L at screening)
    OR
    b. Fecal calprotectin of ≥250 mg/kg or ≥250 μg/g at screening
    OR
    c. Ileocolonoscopy with evidence of active Crohn's disease (defined as ulcerations in the ileum and/or colon) during screening into this study including at the baseline visit.

    Allowed concomitant or prior medical therapies for Crohn's disease
    6. Prior or current medication for Crohn's disease must include at least 1 of the following:
    Have received biologic therapy for the treatment of pediatric Crohn's disease and have had an appropriate washout duration prior to first administration of study intervention and have a documented history of failure to respond to or not tolerate the biologic therapy.
    OR
    Be naïve to biologic therapy (ie, have not demonstrated a history of failure to respond to or failure to tolerate a biologic therapy) and have a prior or current Crohn's disease medication history that includes at least 1 of the following:
    a. Inadequate response to or failure to tolerate current treatment with oral or IV corticosteroids or immunomodulators (6-MP, AZA, or MTX)
    OR
    b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP, AZA, or MTX).
    OR
    c. History of corticosteroid dependence (ie, an inability to successfully taper corticosteroids without a return of the symptoms of Crohn's disease).
    OR
    d. Have required more than 3 courses of oral or IV corticosteroids in the past year.
    7. Must meet concomitant medication dose stability criteria prior to the first administration of study intervention:

    Corticosteroids
    a. If receiving budesonide or beclomethasone dipropionate, the dose must have been stable for at least 2 weeks prior to Week I-0.
    7.1 Criterion modified per Amendment 2
    b. If receiving oral corticosteroids other than budesonide or beclomethasone dipropionate, the dose must be ≤1.5 mg/kg/day prednisone (or its equivalent) up to 40 mg/day prednisone and must have been stable or discontinued for at least 2 weeks prior to Week I-0.
    7.1 Criterion modified per Amendment 2
    c. If IV, or rectal corticosteroids have recently been discontinued, they must have been stopped for at least 2 weeks prior to Week I-0.

    5-ASA, MTX, 6-MP, and AZA compounds:
    d. If receiving oral or rectal 5-ASA compounds, the dose must have been stable for at least 2 weeks prior to Week I-0.
    e. If oral or rectal 5-ASA compounds have been discontinued, they must have been stopped for at least 2 weeks prior to Week I-0.
    f. If receiving MTX, 6-MP, or AZA, the participant must have been taking them for ≥12 weeks and on a stable dose for at least 4 weeks prior to Week I-0.
    g. If the MTX, 6-MP, or AZA have been recently discontinued, they must have been stopped for at least 4 weeks prior to Week I-0.

    Antibiotics
    h. If receiving a single antibiotic as a primary treatment of Crohn's disease, the dose must have been stable for at least 2 weeks prior to Week I-0.

    Enteral Nutrition
    8. If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to Week I-0.

    Please refer to section 5.1 of the protocol for all the inclusion criteria.
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:

    Crohn's disease diagnosis and status
    1. Has complications of Crohn's disease such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of treatment with ustekinumab.
    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 prior to baseline, or 8 weeks prior to 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 prior to Week I-0.
    4. Presence of a stoma.

    Concomitant or Previous Medical Therapies Received
    5. Has received any of the following prescribed medications or therapies within the specified period:
    a. Has ever received ustekinumab or a biologic agent targeting IL-12/23 or IL-23, including, but not limited to, briakinumab, brazikumab, guselkumab, mirikizumab (formerly LY3074828), and risankizumab.
    c. Has ever received thalidomide or related agents.
    d. Has received natalizumab within 12 months of Week I-0.
    e. Has received agents that deplete B or T cells (eg, rituximab, alemtuzumab, or visilizumab) within 12 months of Week I-0 or continue to manifest depletion of B or T cells more than 12 months after completion of therapy with lymphocyte depleting agents.
    f. Has received vedolizumab without appropriate washout period prior to Week I-0.
    g. Has received other immunomodulatory agents (eg, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil) within 8 weeks prior to Week I-0.
    h. Has received anti-TNFα biologic agents without an appropriate washout period prior to Week I-0.
    i. Has used any investigational intervention within 4 weeks prior to Week I-0 or within 5 half-lives of the investigational intervention, whichever is longer.
    j. Has used apheresis (ie, Adacolumn apheresis, Cellsorba apheresis) within 2 weeks prior to Week I-0.
    k. Have used laxatives, except preparations for endoscopy or other procedures, within 1 week prior to screening procedures.
    l. Has initiated enteral nutrition therapy <3 weeks prior to the first administration of study intervention at Week I-0. (Participants who are on a stable regimen ≥2 weeks prior to the anticipated first administration of study intervention at Week I-0 may be considered for enrollment).
    m. Has an indwelling catheter.
    n. Is on total (complete) or partial (supplemental) parenteral nutrition or anticipated to require during enrollment in the study. If recently on total (complete) or partial (supplemental) parenteral nutrition, much have stopped therapy at least <3 weeks before baseline.
    o. Is on rectal therapy for Crohn's disease with either 5-ASA medications or corticosteroids.
    p. Is on IV steroids
    q. Is on more than one antibiotic prescribed for the treatment of Crohn's disease

    Infections or Predisposition to Infections
    6. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening.
    7. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis, recurrent urinary tract infection (eg, recurrent pyelonephritis, chronic cystitis), an open, draining, or infected skin wound, or a skin ulcer.
    8. Have clinically significant immune deficiency syndrome (eg, severe combined immunodeficiency syndrome, T-cell deficiency syndromes, B cell deficiency syndromes, or chronic granulomatous disease) and/or monogenic cause of IBD. With children who carry a diagnosis of VEOIBD, an evaluation for immunodeficiency and monogenic forms of IBD should have been performed.
    9. Have a known history of infection with HIV or test positive at screening.
    10. Has evidence of herpes zoster infection within 8 weeks prior to Week I-0.

    Please refer to section 5.2 of the protocol for all the exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Global
    1. Clinical remission at Induction Week 8 (Week I-8).

    US-specific
    2. Clinical remission at Maintenance Week (Week M-44).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week I-8
    2. Week M-44
    E.5.2Secondary end point(s)
    Secondary endpoints are:

    Global
    1. Clinical remission at Week I-6
    2. Clinical response at Week I-8.
    3. Clinical response at Week I-6
    4. Endoscopic response at Week M-8
    5. Clinical response at Week M-8

    The following endpoints will be evaluated for participants who are clinical responders at Week I-8
    6. Clinical remission at Week M-44
    7. Endoscopic response at Week M-44
    8. Clinical response at Week M-44
    9. Corticosteriod-free clinical remission at Week M-44
    10. Corticosteriod-free clinical response at Week M-44
    11. Durable clinical remission at Week M-44

    US-specific
    12. Clinical Remission at Week I-8
    13. Clinical Remission at Week I-6
    14. Clinical Response at Week I-8
    15. Clinical response at Week I-6.
    16. Endoscopic response at Week M-8.*
    17. Clinical response at Week M-8.*

    The following endpoints will be evaluated for participants who are clinical responders at Week I-8:
    18. Endoscopic response at Week M-44.
    19. Clinical response at Week M-44.
    20. Corticosteroid-free clinical remission at Week M-44.
    21. Corticosteroid-free clinical response at Week M-44.
    22. Durable clinical remission at Week M-44.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3, 13 and 15 Week I-6
    2, 12 and 14 Week I-8
    4, 5, 16 and 17 Week M-8
    6 - 11 and 18 - 22 Week M-44
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Maintenance Period: Randomized, double-blind, parallel group 2-arm study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Germany
    Hungary
    Japan
    Poland
    Russian Federation
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 90
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 26
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 64
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    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 who complete participation at Week M-44 may be eligible to enter an Long-Term Extension (LTE) and continue to receive SC ustekinumab at the dose they were receiving on completion of the maintenance period.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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