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    Summary
    EudraCT Number:2019-004224-38
    Sponsor's Protocol Code Number:CNTO1275PUC3001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-20
    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 ConcernedGermany - PEI
    A.2EudraCT number2019-004224-38
    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 Ulcerative Colitis
    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 Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    UNIFI-Jr
    A.4.1Sponsor's protocol code numberCNTO1275PUC3001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/281/2020
    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 N.V.
    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 Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    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 active UC.
    2. To evaluate the safety profile of ustekinumab in pediatric participants with moderately to severely active UC.
    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. 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, blood coagulation, 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.

    UC diagnosis and status
    4. Must have had UC diagnosed for at least 1 month prior to screening.
    5. Must have biopsy confirmation that is consistent with a diagnosis of UC (eg, crypt distortion, crypt abscess, and goblet cell depletion).
    6. Have moderately to severely active UC, defined as a baseline Mayo score of 6 through 12, inclusive, with a screening Mayo endoscopy subscore ≥2 as determined by a central review of the video of the endoscopy.

    Allowed concomitant or previous medical therapies for UC
    7. Prior or current medication for UC must include at least one of the following:
    Have received biologic therapy (ie, TNFα antagonist or vedolizumab) for the treatment of pediatric UC 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 treatment;
    OR
    Be naïve to biologic therapy or have not demonstrated a history of failure to respond to, or tolerate a biologic therapy and have a prior or current UC 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 or AZA or MTX)
    OR
    c. History of corticosteroid dependence (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
    OR
    d. Have required more than 3 courses of oral or IV corticosteroids in the past year.
    8. Must meet concomitant medication criteria prior to the first administration of study intervention:

    Corticosteroids
    a. If receiving budesonide or beclomethasone dipropionate, the dose must have been stable or discontinued for at least 2 weeks prior to Week I-0.
    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) and must have been stable or discontinued for at least 2 weeks prior to Week I-0.
    c. IV or rectal corticosteroids must have been discontinued for at least 2 weeks prior to Week I-0.

    5-Aminosalicylates, 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 UC, the dose must have been stable or discontinued for at least 2 weeks prior to Week I-0. Participants cannot be receiving more than one antibiotic for the primary treatment of UC.

    Enteral Nutrition
    9. If previously receiving enteral nutrition providing more than 80% of daily caloric needs, therapy must have been stopped for at least 4 weeks prior to Week I-0.Malignancy or increased potential for malignancy

    Please refer to 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:

    UC Diagnosis and Status
    1. Have severe, extensive colitis as evidenced by:
    a. Investigator judgment that the participant is likely to require a colectomy within 12 weeks of Week I-0.
    OR
    b. Symptom complex at screening or Week I-0 visit that includes at least 4 of the following:
    • Diarrhea with ≥6 bowel movements/day with macroscopic blood in stool
    • Focal severe or rebound abdominal tenderness
    • Persistent fever (≥37.5°C) for more than 5 days
    • Persistent tachycardia for more than 5 days
    • Anemia (hemoglobin <8.5 g/dL)
    2. Have UC limited to the rectum only or to <20 cm of the colon.
    3. Presence of a stoma.
    4. Presence or history of a fistula.
    5. Have severe, fixed symptomatic stenosis of the large or small intestine.
    6. Require, or required within the 2 months prior to screening, surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from study intervention treatment.
    7. Presence or history of colonic or small bowel obstruction within 6 months prior to screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (dilation of the colon or small bowel proximal to the strictureon barium radiograph or an inability to traverse the stricture at endoscopy).
    8. History of extensive colonic resection (eg, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study intervention on clinical disease activity.
    9. Presence on screening endoscopy of adenomatous colonic polyps, if not removed prior to study entry, or history of adenomatous colonic polyps that were not removed.
    10. Have evidence of Crohn’s disease:
    a. Small intestinal or ileal disease by upper GI small bowel follow-through, ileocolonoscopy with histology, video capsule endoscopy, or magnetic resonance enterography
    b. Noncaseating and non-mucin granulomas that are suggestive of a diagnosis of Crohn’s disease on colonoscopy
    c. Skip lesions on colonoscopy including absolute rectal sparing, with a normal rectum both endoscopically and histologically
    d. Perianal disease

    Concomitant or previous medical therapies received
    11. Have received the following concomitant or previous medical therapies:
    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 LY-3074828), and risankizumab.
    b. Has ever received thalidomide or related agents.
    c. Has received natalizumab within 12 months of Week I-0.
    d. 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.
    e. Has received vedolizumab without an appropriate washout period prior to Week I-0.
    f. Has received other oral immunomodulatory agents (eg, 6-thioguanine [6-TG], cyclosporine, tacrolimus, sirolimus, or mycophenolate mofetil [MMF]) within 8 weeks prior to Week I-0.
    g. Has received anti-TNFα biologic agents without an appropriate washout period prior to Week I-0.
    h. 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.
    i. Has used apheresis (ie, Adacolumn apheresis, Cellsorba apheresis) within 2 weeks prior to Week I-0.
    j. Has used laxatives, except preparations for endoscopy or other procedures, within 1 week prior to screening procedures.
    k. Has an indwelling catheter.
    l. 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, must have stopped therapy at least <3 weeks before baseline.
    m. Is on rectal therapy for UC with either 5-ASA medications or corticosteroids.
    n. Is on IV steroids
    o. Is on more than one antibiotic prescribed for the treatment of UC.

    Infections or predisposition to infections
    12. Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening.
    13. 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.

    Please refer to 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 response at Week I-8.
    2. Symptomatic remission at Week I-8.
    3. Clinical remission at Week I-8 as assessed by the Pediatric Ulcerative Colitis Activity Index (PUCAI) score.
    4. Endoscopic improvement at Week I-8.
    5. Clinical remission at Maintenance Week (Week M-44.)
    6. Symptomatic remission at Week M-44.
    7. Clinical remission at Week M-44 as assessed by the PUCAI score.
    8. Endoscopic improvement at Week M-44.
    9. Clinical remission at Week M-44 and not receiving corticosteroids for at least 90 days prior to Week M-44 among participants who received corticosteroids at Week M-0.
    10. Clinical remission at Week M-44 for participants who are in clinical remission at Week I-8.

    US-specific
    11. Clinical remission at Induction Week 8 (Week I-8).
    12. Clinical response at Week I-8.
    13. Symptomatic remission at Week I-8.
    14. Clinical remission at Week I-8 as assessed by the PUCAI score.
    15. Endoscopic improvement at Week I-8.
    16. Symptomatic remission at Week M-44.
    17. Clinical remission at Week M-44 as assessed by the PUCAI score.
    18. Endoscopic improvement at Week M-44.
    19. Clinical remission at Week M-44 and not receiving corticosteroids for at least 90 days prior to Week M-44 among participants who received corticosteroids at Week M-0.
    20. Clinical remission at Week M-44 for participants who are in clinical remission at Week I-8.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 to 4. and 11 to 15. Week I-8
    5 to 10. and 16 to 20. 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 months4
    E.8.9.1In the Member State concerned days17
    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 41
    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 Decision2020-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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