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    The EU Clinical Trials Register currently displays   43234   clinical trials with a EudraCT protocol, of which   7153   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-001605-93
    Sponsor's Protocol Code Number:D5272C00001
    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:2020-05-05
    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 number2018-001605-93
    A.3Full title of the trial
    A 54-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (Expedition Lead-in)
    54 hétig tartó, többközpontú, randomizált, kettős vak,
    placebokontrollos, párhuzamos csoportos, II. fázisú vizsgálat a
    brazikumab hatásosságának és biztonságosságának felmérésére
    közepesen-erősen aktív colitis ulcerosában szenvedő résztvevőknél
    (Expedition Lead-In)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    Phase 2 Dose-finding UC Study
    A.4.1Sponsor's protocol code numberD5272C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03616821
    A.5.4Other Identifiers
    Name:INDNumber:137684
    Name:LegacyNumber:#3151-201-008
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.6E-mailinformation.center@astrazeneca.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.3.1Product nameBrazikumab
    D.3.2Product code MEDI2070
    D.3.4Pharmaceutical form Solution for injection/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 INNBRAZIKUMAB
    D.3.9.1CAS number 1610353-18-8
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
    D.3.9.4EV Substance CodeSUB188673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 No
    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 typefully human IgG2 monoclonal 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 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 nameBrazikumab
    D.3.2Product code MEDI2070
    D.3.4Pharmaceutical form Solution for injection/infusion 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 INNBRAZIKUMAB
    D.3.9.1CAS number 1610353-18-8
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
    D.3.9.4EV Substance CodeSUB188673
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 No
    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 typefully human IgG2 monoclonal 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/infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis is a type of inflammatory bowel disease that causes the lining of the large intestine (colon) to become inflamed (irritated and swollen) which may cause ulcers and bleeding.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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
    -To compare the efficacy of brazikumab with that of placebo to achieve clinical remission at week 10
    E.2.2Secondary objectives of the trial
    -To compare the efficacy of brazikumab with that of placebo to achieve sustained clinical remission
    -To compare the efficacy of brazikumab with that of placebo to achieve corticosteroid-free (CS-free) clinical remission
    -To compare the efficacy of brazikumab with that of placebo to achieve clinical response
    -To compare the efficacy of brazikumab with that of placebo to achieve endoscopic improvement
    -To evaluate the pharmacokinetics (PK) and immunogenicity of brazikumab
    -To characterize the exposure-response relationships of brazikumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Ability to provide informed consent prior to any study procedures and willing and able to attend all study visits.
    2.Aged 18 to 80 years of age at the time of signing the informed consent.
    3.Diagnosis of UC with an onset of symptoms for a minimum of 3 months prior to Screening.
    4.Evidence of UC extending proximal to the rectum (≥ 15 cm of involved colon).
    5.Moderately to severely active UC as defined by (5a and 5b must be met):
    (a) Stool Frequency and Rectal Bleeding subscores will be obtained during Screening on an eDiary. The following criteria must also be met:
    i. Average daily mMS Stool Frequency subscore ≥ 1 AND
    ii. Average daily mMS Rectal Bleeding subscore ≥ 1
    (b) Modified Mayo endoscopic subscore of ≥ 2 based on a full colonoscopy within 14 days prior to initial IRT randomization.
    6.Participant had an inadequate response or intolerance to intervention with conventional treatment (oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6 mercaptopurine) or prior biological treatment or demonstrated CS dependence for the treatment of UC. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.
    7.Where applicable, participants taking any of the following medications must be at a stable dose or discontinued:
    (a) Oral 5-aminosalicylates must be at a stable dose for 2 weeks prior to the screening colonoscopy.
    (b) Oral prednisone up to 25 mg/day or equivalent, must be at a stable dose for 2 weeks prior to the screening colonoscopy and kept stable until the Week 10 assessment.
    (c) Oral budesonide up to 9 mg/day, must be at a stable dose for 2 weeks prior to the screening colonoscopy and kept stable until the Week 10 assessment.
    (d) Topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids should be discontinued within 2 weeks prior to screening colonoscopy. Rectal therapies should not be restarted after the screening colonoscopy.
    (e) An immunomodulator: participants must have been on treatment for a minimum of 8 weeks and must be kept at stable doses as below:
    i. Azathioprine, must be at a stable dose for 4 weeks prior to screening, OR
    ii. 6-mercaptopurine, must be at a stable dose for 4 weeks prior to screening, OR
    iii. Methotrexate, must be at a stable dose for 4 weeks prior to screening.
    8.Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention
    9.Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
    10.Non sterilized males who are sexually active with a female partner of childbearing potential should use condoms during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
    11.No known history of active TB or latent TB without completion of appropriate intervention.
    E.4Principal exclusion criteria
    1.Participant has UC limited to the rectum (ie, not beyond 15 cm of the anal verge).
    2.Current diagnosis of fulminant colitis, a diagnosis of CD or indeterminate colitis, presence or history of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or untreated bile acid malabsorption. Participants with a history of toxic megacolon within 12 months of screening are excluded.
    3.History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, ileostomy, or other prior colonic resection, or need for surgical intervention for control of UC anticipated within 6 months.
    4.Participant has received the following treatment:
    (a) Infliximab: within 8 weeks prior to randomization.
    (b) Adalimumab, certolizumab pegol, or golimumab: within 8 weeks prior to randomization.
    (c) Vedolizumab or ustekinumab within 12 weeks of randomization.
    (d) Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to randomization.
    (e) Fecal microbiota transplantation: within 8 weeks prior to randomization.
    5.Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23 (risankizumab, brazikumab, mirikizumab, guselkumab, tildrakizumab).
    6.Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy.
    7.Participant received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening.
    8.Participants who received IV or intramuscular steroids within 2 weeks prior to Screening.
    9.Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s), or receiving other investigational agent(s).
    10.Participant received a transfusion of blood, plasma, or platelets within 30 days prior to Screening.
    11.Participant received a Bacille Calmette-Guérin vaccination within 12 months of randomization or any other live vaccine less than 4 weeks prior to randomization.
    12.Participant has any of the following criteria related to infections:
    (a) Evidence of a recent systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment.
    (b) Any infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks of Screening.
    (c) Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening.
    (d) Clinically significant chronic infection that has not resolved within 8 weeks of Screening.
    (e) Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with study medical monitor.
    (f) Clinical evidence of or suspected to have an abscess during Screening.
    (g) Any underlying condition that predisposes the participant to infections.
    (h) Participant had previous allogenic bone marrow transplant or history of organ or cell-based transplantation.
    (i) Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy.
    (j) Signs or symptoms of ongoing infection due to intestinal pathogens.
    13.Participant has known or suspected history of chronic use of NSAIDs and/or opiates, drug, or alcohol abuse.
    14.History of cancer with the following exceptions:
    history of basal cell carcinoma and/or squamous cell carcinoma of the skin OR carcinoma in
    situ of the cervix; with apparent successful curative therapy, greater than 12 months prior to
    screening.
    15.Clinically significant cardiovascular conditions.
    16.Prolonged QTcF interval or conditions leading to additional risk for QT prolongation.
    17.Clinically significant kidney disease including but not limited to:
    (a) Acute kidney injury within 6 weeks of Screening.
    (b) Chronic kidney disease with an estimated glomerular filtration rate of less than 30 mL/min.
    18.Abnormal laboratory results at Screening as defined in the study protocol
    19.Participant is pregnant or breastfeeding or plans to become pregnant during the study.
    20.Participant has other known, pre existing, clinically significant medical conditions that are not associated with UC and are uncontrolled with standard treatment.
    21.Participant has any disorder that may compromise the ability of the participant to give written informed consent and/or to comply with all required study procedures.
    22.Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical remission:
    - modified Mayo Score (mMS):
    Endoscopy subscore = 0 or 1, AND
    Rectal bleeding subscore = 0, AND
    Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 10
    E.5.2Secondary end point(s)
    1-Sustained clinical remission:
    -mMS at both Week10 and Week54:
    Endoscopy subscore = 0 or 1, AND
    Rectal bleeding subscore = 0, AND
    Stool frequency subscore = 0 or1 AND at least a 1 point decrease from baseline.
    2- CS-free clinical remission:
    -mMS at Week 54 for participants who are CS-free for at least the last 12 weeks before the assessment at Week 54:
    Endoscopy subscore = 0 or 1, AND
    Rectal bleeding subscore = 0, AND
    Stool frequency subscore = 0 or 1 AND at least a 1 point decrease from baseline.
    3-Clinical response:
    -Reduction in mMS ≥ 2 points from baseline AND ≥ 30% from baseline AND a decrease in the rectal bleeding score ≥ 1 point from baseline or a score of 0 or 1 at Week10
    4-Endoscopic improvement:
    -Endoscopy subscore ≤ 1 at Week10
    5-Population PK model of serum concentrations of brazikumab and analysis for serum anti-brazikumab antibodies over the 54 week treatment period.
    6-Exposure-response model linking primary endpoints to metrics of model-predicted individual brazikumab exposures over the 54 week treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    as listed in E.5.2
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Blood and stool samples will be collected and analyzed to evaluate protein, nucleic acid, and
    cellular biomarkers, optional blood sample for genetic research
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA85
    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
    Canada
    India
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United States
    Austria
    France
    Germany
    Hungary
    Italy
    Poland
    Spain
    United Kingdom
    Czechia
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 255
    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)
    The sponsor will not provide any study intervention after the end of the study unless the participant enters the open-label extension study with brazikumab (D5272C00002).
    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 Decision2021-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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