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    Summary
    EudraCT Number:2018-002629-51
    Sponsor's Protocol Code Number:CNTO1275CRD3008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-01-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-002629-51
    A.3Full title of the trial
    A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients 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 to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive Tract
    A.3.2Name or abbreviated title of the trial where available
    Patient Optimization With ustekinumab Re-induction (POWER)
    A.4.1Sponsor's protocol code numberCNTO1275CRD3008
    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 N.V.
    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 Pharmaceutica NV
    B.4.2CountryBelgium
    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 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 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 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.3.9.4EV 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 in pre-filled syringe
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    A chronic inflammatory bowel disease that affects the lining of the digestive tract
    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
    The primary objective is to evaluate the achievement of clinical response at Week 16 following a single intravenous (IV) re-induction dose of ~6 milligram per kilogram (mg/kg) ustekinumab, compared with continuing regular subcutaneous (SC) dosing every 8 weeks (q8w) 90 milligram (mg) ustekinumab administration, in participants with secondary loss of response (LoR) to SC q8w 90 mg ustekinumab maintenance therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    ● Evaluate the achievement of clinical response and clinical remission, as well as the reduction in inflammatory biomarkers (serum C-reactive protein [CRP] and fecal calprotectin [FCal] levels), after IV ustekinumab re-induction.
    ● Assess the overall safety of IV ustekinumab re-induction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each potential participant must satisfy all the following criteria to be enrolled in the study:
    1. Male or female aged ≥18 years (or the legal age of consent in the jurisdiction in which the study is taking place if older than 18 years).
    2. A history of 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.
    3. Initially responded to ustekinumab induction therapy (a), administered according to the local label, followed by secondary LoR to ustekinumab (b).
    a) Initial response to ustekinumab as defined in Section 10.2.
    b) Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a crohn’s disease activity index (CDAI) score of ≥220 and ≤450 with at least one of the following:
    - Elevated CRP (>3.0 milligram per litre [mg/L]); and/or
    - Elevated fCal (>250 mg/kg); and/or
    - Endoscopy (performed ≤3 months before baseline) with evidence of active Crohn’s disease (defined as one or more ulcerations in the ileum and/or colon).

    Participants must currently be on a SC 90mg ustekinumab q8w maintenance dose regimen and have received at least 2 doses of SC 90
    mg ustekinumab treatment 8 weeks apart prior to enrollment

    4. The following medications for the treatment of Crohn’s disease are permitted providing the doses indicated are stable for at least 3 weeks before baseline or have been discontinued at least 3 weeks before baseline:
    ● Oral 5-aminosalicylic acid (5-ASA) compounds.
    ● Oral corticosteroids (eg, prednisone, budesonide) at a prednisone-equivalent dose of ≤40 mg/day or ≤9 mg/day of budesonide.
    ● Antibiotics used as the primary treatment of Crohn’s disease.
    Any participants receiving conventional immunomodulators (ie, azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) must have been taking them for ≥12 weeks and must have been on a stable dose for a least 4 weeks before baseline.
    5. The following laboratory test results are within the specified limits at screening:
    ● Hemoglobin ≥8.5 g/dL (≥85 g/L).
    ● White blood cell (WBC) count ≥3.5 x 10^3/µL (≥3.5 GI/L).
    ● Neutrophils ≥1.5 x 10^3/µL (≥1.5 GI/L).
    ● Platelets ≥100 x 10^3/µL (≥100 GI/L).
    ● Serum creatinine <1.7 mg/dL (≤150 μmol/L).
    ● Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels ≤2 times the upper limit of normal for the laboratory conducting the test.
    ● Direct (conjugated) bilirubin <1.0 mg/dL (<0.01 g/L).
    6. Meet the following TB screening criteria:
    ● No history of latent or active TB before screening. An exception is made for participants who have a history of latent TB and are currently receiving treatment for latent TB, will initiate treatment for latent TB prior to first administration of study intervention, or have documentation of having completed appropriate treatment for latent TB within 5 years prior to the first administration of study intervention. It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide appropriate documentation.
    ● No signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    ● No recent close contact with a person with active TB. If there has been such contact, the participant will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, will receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study intervention.
    ● Meets all other protocol-specified TB inclusion criteria
    8. All female participants of childbearing potential must have a negative highly sensitive serum (-human chorionic gonadotropin [-hCG]) pregnancy test at screening and a negative urine pregnancy test at baseline and prior to each administration of study intervention.
    9. A male participant who is heterosexually active with a woman of childbearing potential and is not surgically sterile must agree to use a double-barrier method of birth control and not donate sperm during the study and for 15 weeks after receiving study intervention.
    11. Sign an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study.

    Please see protocol for an overview of all inclusion criteria
    E.4Principal exclusion criteria
    1.Complications of Crohn’s disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with 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 before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided 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.Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline.
    4.A draining stoma or ostomy.
    5.Received any of the following prescribed medications or therapies within the specified period:
    ● Use of IV ustekinumab re-induction after the initial weight-tiered based IV induction dose of ustekinumab
    ● Any known history of shortened frequency of SC dose administration for a secondary loss of response where the participant did not,
    in the opinion of the treating physician, benefit from the dose interval shortening.
    ● Any off-label use of ustekinumab, including additional IV re-induction or shortened frequency of subcutaneous dose administration, after the initial weight-tiered based IV induction dose of ustekinumab.
    ●Intravenous corticosteroids as a treatment for Crohn’s disease within 3 weeks before baseline.
    ●Oral immunomodulatory agents other than AZA, 6-MP, or MTX within 4 weeks before baseline.
    ●Any other investigational agent for Crohn’s disease, unless at least 3 months or 5 half-lives have elapsed since the last dose.
    ●Treatment with apheresis or total parenteral nutrition as a treatment for Crohn’s disease within 3 weeks before baseline.
    6.A stool culture or other examination in the last 4 months that is positive for an enteric pathogen, including Clostridium difficile toxin, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.
    7.Received a Bacille Calmette-Guérin vaccination within 12 months before baseline or any other live bacterial or live viral vaccination within 2 weeks before baseline.
    8.A history of, or ongoing, chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection, recurrent urinary tract infection or open, draining, or infected skin wounds or ulcers.
    9.Any current signs or symptoms of infection. Established non-serious infections need not be considered exclusionary at the discretion of the investigator.
    10.A history of serious infection including any infection requiring hospitalization or IV antibiotics, for 8 weeks before baseline.
    11.Evidence of a herpes zoster infection ≤8 weeks before baseline.
    12.A history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening; refer to Inclusion Criterion 6 for information regarding eligibility with a history of latent TB.
    13.Evidence of current active infection, including TB, or a nodule suspicious for lung malignancy on screening or any other available chest radiograph, unless definitively resolved surgically or by additional imaging and with source document confirmation.
    14.A current or (lifetime) history of a nontuberculous mycobacterial infection or serious opportunistic infection.
    15.Known to be infected with human immunodeficiency virus, hepatitis B, or hepatitis C.
    16.Severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or any signs or symptoms thereof.
    17.A transplanted organ, with the exception of a corneal transplant performed >12 weeks before screening.
    18.A known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
    19.Any known malignancy or a history of malignancy, with the exception of: basal cell carcinoma; squamous cell carcinoma in situ of the skin; cervical carcinoma in situ that has been treated with no evidence of recurrence; or squamous cell carcinoma of the skin that was treated with no evidence of recurrence within 5 years before screening.
    20.Previous allergy immunotherapy for prevention of anaphylactic reactions.
    21.Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.

    Please see protocol for an overview of all exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical response at Week 16, defined as a ≥100-point reduction from the baseline CDAI score or a CDAI score <150 points.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 16
    E.5.2Secondary end point(s)
    1. Clinical remission at Week 16, defined as a CDAI score of <150 points.
    2. Clinical response at Week 8, defined as a ≥100-point reduction from the baseline CDAI score or a CDAI score <150.
    3. Clinical remission at Week 8, defined as a CDAI score of <150 points.
    4. Normalization of CRP and/or FCal concentration(s) at Week 16, among participants with an elevated CRP and/or FCal at baseline.
    5. Clinical remission at Week 24, defined as a CDAI score of <150 points.
    6. Clinical response at Week 24, defined as a ≥100-point reduction from the baseline CDAI score or a CDAI score <150.
    7. Normalization of CRP and/or FCal concentration(s) at Week 24, among participants with an elevated CRP and/or FCal at baseline.
    8. Safety endpoints, including the proportion of participants with at least one adverse event and subcategories of adverse events (all infections, all serious adverse events and serious infections), as well as changes in clinical laboratory test results.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 & 4. At week 16
    2 & 3. At week 8
    5, 6 & 7. At week 24
    8. Throughout the study (Screening to week 24 or early termination)
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker assessments
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Austria
    France
    Germany
    Italy
    Netherlands
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 185
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 200
    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)
    None
    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 Decision2020-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-16
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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