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    Summary
    EudraCT Number:2019-001866-14
    Sponsor's Protocol Code Number:3150-303-008
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-04-09
    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 number2019-001866-14
    A.3Full title of the trial
    An Open-label, Long-term Extension Study of Brazikumab in Participants with Moderately to Severely Active Crohn’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Extension Study of Brazikumab in Crohn’s Disease
    A.4.1Sponsor's protocol code number3150-303-008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03961815
    A.5.4Other Identifiers
    Name:INDNumber:111,773
    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 SponsorAllergan Limited
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Limited
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressMarlow International, The Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailML-CTRG@Allergan.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 Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
    D.3.4Pharmaceutical form 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 INNBRAZIKUMAB
    D.3.9.1CAS number 1610353-18-8
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
    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 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 Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
    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 INNBRAZIKUMAB
    D.3.9.1CAS number 1610353-18-8
    D.3.9.3Other descriptive nameAnti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139, AGN-151-598
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to Severely Active Crohn’s Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's disease is a disease that causes the intestines to become swollen and may develop ulcers
    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
    To assess the safety of long-term treatment with brazikumab in CD participants who previously completed studies 3150-301-008 or 3150-302-008, or discontinued from Study D5170C00002 due to its termination, or discontinued from Study 3150-301-008 at or after Week 12 due to lack of efficacy.
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female participants with successful completion or early termination due to lack of efficacy from Study 3150-301-008, 3150-302-008, or discontinuation from therapy due to termination of Study D5170C00002.
    - No prior history of active TB and meets all TB-related criteria as defined in more detail in the protocol.
    - Each participant must have had the ileocolonoscopic procedure at the final visit of the lead-in study (either 3150-301-008 or 3150-302-008), no greater than 28 days before baseline of this study, or must consent to having one performed prospectively at baseline in this study. In the case of participants from Study D5170C00002, participants must consent to having one performed at baseline (Visit 1) and again at Week 52 (Visit 14) to be eligible for participation.
    - Agree to comply with contraception requirements as defined in more detail in the protocol.
    - Study participants must be willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period as defined in more detail in the protocol.
    - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
    - Written informed consent from the participant has been obtained prior to any study-related procedures.
    - Legally authorized representative consent has been obtained (if applicable).
    - Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]).
    - Demonstration of adequate compliance with the study procedures in Study 3150-301-008, 3150-302-008, or D5170C00002, in the opinion of the investigator and/or sponsor.
    - 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.
    E.4Principal exclusion criteria
    - Any participant with an unresolved AE from a lead-in study, (i.e., a clinically significant finding on physical examination, clinical laboratory test, or 12-lead ECG [including QTc prolongation]) that, in the investigator’s opinion, would limit the participant’s ability to participate in or complete the study. Any unresolved AE related to an infection will require further discussion with the study medical monitor.
    - Current diagnosis of ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or any demyelinating condition. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline.
    - Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
    - Any other condition or finding that, in the investigator’s or sponsor’s opinion, would either confound proper interpretation of the study or expose a participant to unacceptable risk, including but not limited to clinically significant findings on physical examination, clinical laboratory test, 12-lead ECG (including QTc prolongation), or clinically significant renal, hepatic, or cardiopulmonary disease.
    - History of cancer with the exceptions listed in detail under criterium 1.05.
    - Participant requires additional immunosuppressive therapy (aside from permitted concomitant medication), biological treatment or prohibited treatment.
    - Participant received a Bacille Calmette-Guérin vaccination within 12 months of baseline (Visit 1) or any other live vaccine < 4 weeks prior to baseline (Visit 1). Participant agrees to refrain from receiving live vaccines during the course of the study.
    - Participant receives a prohibited medication during participation in the study or during screening for this study.
    - Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3150-303-008.
    - Abnormal laboratory results at baseline as defined more detail in the protocol.
    - Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly.
    - Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, sub-investigator, study coordinator, other study staff member, or employee of Allergan, or the participant is a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is enrolled in this study at another clinical study site.
    E.5 End points
    E.5.1Primary end point(s)
    - AEs
    - Clinical laboratory values
    - Vital signs
    - ECGs
    E.5.1.1Timepoint(s) of evaluation of this end point
    - AE/SAE assessment: Assessed at Baseline & at 4-week intervals through week 52
    - Clinical laboratory values:
    Serum chemistry, hematology, and CRP: Baseline, Week 12, Week 24, Week 36, Week 52
    HbA1c, FCP (stool): Baseline, Week 24, Week 52
    Urinalysis: Baseline, Week 52
    Pregnancy test: Baseline, at 4-week intervals through week 52
    - Vital signs: All vital signs (e.g. BP, Temperature) should be collected prior to, and immediately following, dosing and recorded on the eCRF.
    - ECG: Baseline, Week 52
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    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 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
    Extension 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 trial1
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA180
    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
    Australia
    Austria
    Belgium
    Bulgaria
    Canada
    China
    Czech Republic
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Taiwan
    Ukraine
    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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 75
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 625
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1000
    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 Decision2020-04-16
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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