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    Summary
    EudraCT Number:2018-004346-42
    Sponsor's Protocol Code Number:D5271C00001
    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:2019-06-17
    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 number2018-004346-42
    A.3Full title of the trial
    A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease
    A.3.2Name or abbreviated title of the trial where available
    52-Week Phase 2b/3 Crohn’s Disease Study
    A.4.1Sponsor's protocol code numberD5271C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03759288
    A.5.4Other Identifiers
    Name:IND Number:111773
    Name:LegacyNumber:#3150-301-008
    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 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 No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Humira®
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH Co. KG
    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.3.4Pharmaceutical 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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 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 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 nameMEDI2070
    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 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 No
    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
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 3
    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
    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
    Crohn's disease is a condition that affects the lining of the digestive tract due to inflammation and may result in ulcers and/or strictures.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    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
    Stage 1: To compare the efficacy of brazikumab with that of placebo to achieve CDAI remission at Week 12
    Stage 2: To compare the efficacy of brazikumab with that of Humira® to achieve endoscopic response and clinical remission at Week 52 in participants who are BM+
    E.2.2Secondary objectives of the trial
    Stage1
    Compare efficacy of brazikumab (IMP) with placebo
    •endoscopic response, CDAI response, clinical remission [W(week)12]
    •CDAI remission, CDAI response, endoscopic response, clinical remission (W12 and W52)
    •CDAI remission, CDAI response, endoscopic response, SES-CD total score of 0-2, endoscopic remission, clinical remission (W52)
    •endoscopic response (W12) and endoscopic remission (W52)
    •Establish serum IL22 concentration Baseline clinical cutoff value to predict IMP efficacy
    Stage2 (BM+ patients)
    Compare efficacy of IMP with Humira
    •endoscopic response, clinical remission (W12 and W52)
    •endoscopic remission, clinical remission (W52)
    •CS-free endoscopic remission, clinical remission (W52)
    And in patients taking CS at baseline
    •endoscopic response, clinical remission (W12)
    •endoscopic response (W12), endoscopic remission (W52), clinical remission (W12, 52)
    Stage 1 and 2
    Evaluate IMP PK, immunogenicity, safety, tolerability
    Characterize IMP exposure-response relationships
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive.
    2 A diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings.
    3 Moderately to severely active CD
    4 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 CD. 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.
    5 Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Probiotics must be at a stable dose.
    6 No known history of active TB or latent TB without completion of appropriate intervention.
    7 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.
    8 Women not of childbearing potential are defined as women who are either permanently sterilized or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12
    months prior to the planned date of randomization without an alternative medical cause.
    9 Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the
    male participant, plus a further 18 weeks.
    10 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
    11 Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period.

    For all detailed Inclusion criteria please refer to the section 5.1 of the protocol.
    E.4Principal exclusion criteria
    1 Participant is unable or unwilling to have endoscopic procedures performed during the study.
    2 History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
    3 History of toxic megacolon within 3 months prior to Randomization (Day 1).
    4 Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma, ostomy, or extensive colonic resection are excluded.
    5 Participant has an enterocutaneous or enterovesicular fistula. Participants with other active fistulas, including perianal fistulas, may be considered for enrollment if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess).
    6 Bowel perforation during the 6 months prior to Screening or evidence of obstruction within 3 months of Screening.
    7 Complications of CD including short bowel syndrome, strictures/stenoses with obstruction or pre-stenotic dilation, or
    conditions where surgery may be anticipated within 6 months, or other conditions that may confound efficacy evaluations for the study.
    8 Participant has any non-passable colonic stenosis/narrowing identified during the qualifying ileocolonoscopy (successful endoscope passage to the caecum with inability to enter the endoscope into the ileum is not covered under this exclusion criterion, and does not require exclusion).
    9 Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at Screening.
    10 Participant has any of the following related to infections:
    • Evidence of a recent (within 6 months of Randomization [Day 1]) systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment.
    • Any infection requiring hospitalization or treatment with IV antiinfectives (including antiviral treatment) within 4 weeks of Screening.
    11 Previous allogenic bone marrow transplant or history of organ or cellbased transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
    12 Chronic hepatitis B or C infection defined as:
    • Hepatitis B: positive for hepatitis B surface antigen (HBsAg+) or positive for anti–hepatitis B core antibody (HBcAB+) and positive confirmatory PCR for HBV, regardless of anti–hepatitis B surface antibody status
    • Hepatitis C: positive result for hepatitis C antibody and positive confirmatory PCR test for hepatitis C virus
    13 Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection. Participants with positive results of HIV testing by the central laboratory will be excluded.
    14 Participant has received the following treatment:
    • Adalimumab, certolizumab pegol, infliximab, or golimumab: within 8 weeks prior to Randomization (Day 1)
    • Vedolizumab or ustekinumab within 12 weeks prior to Randomization (Day 1)
    • Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to Randomization (Day 1)
    • Fecal microbiota transplantation: within 8 weeks prior to Screening ileocolonoscopy
    15 Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.

    All exclusion criteria with all details cannot be list in this field, please refer to the section 5.2 of the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1:
    a. CDAI remission
    Stage 2:
    a. Endoscopic response
    b. Clinical remission
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1:
    a. at Week 12

    Stage 2:
    a. at Week 52
    b. at Week 52
    E.5.2Secondary end point(s)
    Stage 1:
    A. Endoscopic response
    B. Clinical remission
    C. CDAI response
    D. CDAI remission
    E. CDAI response
    F. Endoscopic response
    G. Clinical remission
    H. Endoscopic remission
    I. Clinical remission
    J. CDAI response
    K. CDAI remission
    L. Endoscopic response
    M. SES-CD total score of 0-2
    N. Endosopic response, endoscopic remission
    O. Population PK model of serum concentrations of brazikumab and analysis for serum anti-brazikumab antibodies
    P. Exposure-response model linking primary endpoint to metrics of model-predicted individual brazikumab exposures
    Q. Exploration of relationship of Baseline serum IL-22 concentration with efficacy of brazikumab and establishment of the serum IL-22 concentration clinical cutoff to stratify participants in Stage 2 through CDAI remission and endoscopic response.
    R. AEs, clinical laboratory values, vital signs, physical exams, ECGs

    Stage 2:
    A. Endoscopic response
    B. Clinical remission
    C. Endoscopic remission
    D. Clinical remission
    E. CS-free endoscopic remission
    F. CS-free clinical remission
    G. CS-free endoscopic remission for participants taking CS at Baseline
    H. CS-free clinical remission for participants taking CS at Baseline
    I. Endoscopic response
    J. Clinical remission
    K. Endoscopic response, endoscopic remission
    L. Clinical remission
    M. Endoscopic response
    N. Clinical remission
    O. Population PK model of serum concentrations of brazikumab and analysis for serum anti-brazikumab antibodies
    P. Exposure-response model linking primary endpoints to metrics of model-predicted individual brazikumab exposures
    Q. Adverse events, clinical laboratory values, vital signs, physical exams, ECGs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage 1:
    A. at Week 12
    B. at Week 12
    C. at Week 12
    D. at both Week 12 and Week 52
    E. at both Week 12 and Week 52
    F. at both Week 12 and Week 52
    G. at both Week 12 and Week 52
    H. at Week 52
    I. at Week 52
    J. at Week 12
    K. at Week 52
    L. at Week 52
    M. at Week 52
    N. Week 12, Week 52
    O. Up to Week 52
    P. Up to Week 52
    Q. at Week 12
    R. Up to Week 52

    Stage 2:
    A. at both Week 12 and Week 52
    B. at both Week 12 and Week 52
    C. at Week 52
    D. at Week 52
    E. at Week 52
    F. at Week 52
    G. at Week 52
    H. at Week 52
    I. at Week 12
    J. at Week 12
    K. at week 12 and Week 52
    L. at both Week 12 and Week 52
    M. at Week 52
    N. at Week 52
    O. Up to Week 52
    P. Up to Week 52
    Q. Up to Week 52
    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 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) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 EEA78
    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
    China
    India
    Israel
    Korea, Republic of
    Russian Federation
    South Africa
    Taiwan
    Ukraine
    United States
    Austria
    France
    Germany
    Hungary
    Italy
    Poland
    Slovakia
    Spain
    United Kingdom
    Czechia
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months5
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 51
    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 208
    F.4.2.2In the whole clinical trial 553
    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)
    No interventions will be dispensed after the end of the study unless the participant enters the open-label brazikumab study (Study D271C00002).
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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