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    Summary
    EudraCT Number:2021-001184-25
    Sponsor's Protocol Code Number:WN42444
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-12-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-001184-25
    A.3Full title of the trial
    A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGES OF ALZHEIMER’S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Gantenerumab in Participants at Risk for or at the Earliest Stages of Alzheimer’s Disease
    A.4.1Sponsor's protocol code numberWN42444
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGantenerumab
    D.3.2Product code Ro 490-9832/F10-03
    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 INNGANTENERUMAB
    D.3.9.2Current sponsor codeRo 490-9832/F10-03
    D.3.9.3Other descriptive nameGANTENERUMAB Ro 490-9832/F10-03
    D.3.9.4EV Substance CodeSUB190296
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameGantenerumab
    D.3.2Product code Ro 490-9832/F10-04
    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 INNGANTENERUMAB
    D.3.9.2Current sponsor codeRo 490-9832/F10-04
    D.3.9.3Other descriptive nameGANTENERUMAB Ro 490-9832/F10-04
    D.3.9.4EV Substance CodeSUB190296
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Alzheimer's Disease (AD)
    E.1.1.1Medical condition in easily understood language
    Alzheimer's disease is a progressive neurologic disorder that causes brain cells to die and leads to memory and thinking problems.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ● To evaluate the efficacy of gantenerumab compared with control on cognition
    E.2.2Secondary objectives of the trial
    ● To evaluate the efficacy of gantenerumab compared with control on clinical progression based on time from randomization to clinical progression to mild cognitive impairment (MCI) or dementia and time to onset of confirmed clinical progression
    ● To evaluate the efficacy of gantenerumab compared with control on cognition and/or function
    ● To evaluate the safety of gantenerumab compared with placebo
    ● To evaluate biomarkers of pharmacodynamics of gantenerumab compared with control
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main Study
    ● Participants who:
    - Are age 60-80 years (inclusive) at the time of signing the ICF
    - Cognitively unimpaired with a screening Clinical Dementia Rating Global Score (CDR-GS) of 0, and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Delayed Memory Index (DMI) >=80
    - Show evidence of cerebral amyloid accumulation
    - Have an available person (referred to as a “study partner” throughout the protocol) who: a) Has frequent and sufficient contact with the participant, and is willing and able to provide accurate information regarding the participant’s cognitive and functional abilities, signs the necessary ICF(s), and has sufficient cognitive capacity to accurately report on the participant’s cognitive and functional abilities; b) Is in sufficiently good general health to have a high likelihood of maintaining the same level of interaction with the participant and participation in study procedures throughout the duration of the study; c) Is fluent in the language of the tests used at the study site; d) Every effort should be made to have same study partner participate throughout the duration of the study
    - Are fluent in the language of the tests used at the study site
    - Have adequate visual and auditory acuity, sufficient to perform neuropsychological testing
    - Have agreed not to donate blood or blood products for transfusion for the duration of the study and for 1 year after the final dose of study drug
    - Have agreed not to participate in other interventional research studies for the duration of this trial
    ● For women of childbearing potential:
    - Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 17 weeks after the final dose of study Treatment

    Optional Blood-Based Biomarker Prescreening Procedure
    ● Participants who:
    - Are age 60-80 years (inclusive) at the time of signing the Blood-Based Biomarker Prescreening Informed Consent Form (ICF)
    - Do not have a known clinical diagnosis of cognitive impairment, MCI, prodromal AD, or any form of dementia
    E.4Principal exclusion criteria
    Exclusions Related to central nervous system (CNS) Disorders
    Participants who:
    - Show any evidence of an underlying neurological or neurodegenerative condition that may lead to cognitive impairment other than AD
    - Have a clinical diagnosis of MCI, prodromal AD, or any form of dementia
    - Have a history or presence of intracranial or intracerebral vascular malformations, aneurysm, subarachnoid hemorrhage, intracerebral macrohemorrhage, or posterior reversible encephalopathy syndrome
    - Have a history of ischemic stroke with clinical symptoms or an acute event that is consistent with a transient ischemic attack or severe, clinically significant CNS trauma
    - Have a history or presence of intracranial mass lesion that could potentially impair cognition or lead to progressive neurological deficits
    - Have infections that may affect brain function or a history of infections that resulted in neurologic sequelae
    - Have a history of major depression, schizophrenia, schizoaffective disorder, or bipolar disorder
    - Are at risk for suicide
    - Have had history of alcohol and/or substance abuse or dependence
    Exclusions Related to Imaging Findings
    Participants who:
    - According to the MRI central reader, show MRI evidence of any of the following:
    * >1 lacunar infarcts
    * Any territorial infarct >1 cm3
    * Any white matter lesion that corresponds to an Overall
    Fazekas score of 3
    - Have a combined number of microbleeds and areas of leptomeningeal hemosiderosis on the MRI of >5
    - Have a presence of any other significant cerebral abnormalities
    - Are not able to tolerate MRI procedures or have a contraindication to MRI
    Exclusions Related to Cardiovascular Disease
    Participants who:
    - Have a history or presence of clinically significant systemic vascular disease or atrial fibrillation
    - Experienced unstable or clinically significant cardiovascular disease
    - Have a history or presence of heart failure
    - Have had uncontrolled hypertension
    Exclusions Related to Hepatic and Renal Disorders
    Participants who:
    - Have chronic kidney disease or confirmed and unexplained impaired hepatic function
    Exclusions Related to Infections and Immune Disorders
    Participants who:
    - Have a history of, or are known to currently have an HIV infection, or hepatitis B or hepatitis C virus infection or spirochete infection of the CNS
    - Have a history or presence of systemic autoimmune disorders
    - Have systemic immunosuppression or immunomodulation
    - Have current COVID-19 infection
    Exclusions Related to Metabolic and Endocrine Disorders
    Participants who:
    - Have abnormal thyroid function
    - Show evidence of folic acid deficiency or vitamin B-12 deficiency
    - Have a screening hemoglobin A1c (HbA1c) >8% or poorly controlled insulin-dependent diabetes with hypoglycemic episodes
    Exclusions Related to Medications
    ● Any previous administration of:
    - Gantenerumab
    - Active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline
    - Passive immunotherapy (Ig) or other long-acting biologic agent to prevent or postpone cognitive decline
    ● Any other investigational treatment within 5 half-lives or 6 months
    ● Any previous administration of sodium oligomannate (GV-971)
    ● Any previous treatment with medications specifically intended to treat symptoms related to Parkinson’s disease or any other neurodegenerative disorder
    ● Anticonvulsant medications, typical and atypical anti-psychotic or neuroleptic medications, anticoagulation medications
    ● Psychedelic drugs and substances, recreational cannabis and illicit use of opioids or ketamine
    ● Medical marijuana, chronic use of prescribed opiates or opioids for pain management and chronic use of prescribed benzodiazepines, barbiturates and hypnotic medications, medical food supplements are allowed if on a stable dose for at least 1 month prior to screening
    ● Nootropics and stimulant medications
    ● Any previous treatment with cholinesterase inhibitors and N-methyl-D-aspartate receptor antagonists
    Additional Exclusions
    ● Participants who:
    - Are pregnant or breastfeeding, or intending to become pregnant
    - Have a deformity of the lumbosacral region of the spine, clinically significant abnormal screening blood, CSF or urine results, impaired coagulation, history of cancer, severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins, hypersensitivity to any gantenerumab excipients
    - Have any other severe or unstable medical conditions that could be expected to progress, recur, or change to such an extent that it could put the participant at special risk, interfere with the participant’s ability to complete the study assessments, or would require the equivalent of institutional or hospital care
    - Reside in a skilled nursing facility such as a convalescent home or long-term care facility
    ● Planned or recent exposure to ionizing radiation that exceeds recommended local guidelines
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from baseline to Year 4 in the Preclinical Alzheimer’s Cognitive Composite-5 (PACC-5) score
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Baseline to Year 4
    E.5.2Secondary end point(s)
    1. Time from randomization to clinical progression to MCI or dementia due to AD based on the diagnosis of the independent Clinical Adjudication Committee (iCAC)
    2. Time to onset of confirmed clinical progression, defined as the time from randomization to the first occurrence of two consecutive visits (approximately 6 months apart) with a CDR-GS >0
    3. Change from baseline to Year 4 in the Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV) and the Cognitive Function Instrument acute (CFIa)
    4. Change from baseline to Year 4 in the Clinical Dementia Rating Sum of Boxes (CDR-SB)
    5. Nature, frequency, severity, and timing of adverse events, serious adverse events, and adverse events of special interest
    6. Physical examinations (including neurological systems), vital signs, blood tests, electrocardiograms (ECGs), and Columbia-Suicide Severity Rating Scale (C-SSRS)
    7. Nature, frequency, severity, and timing of MRI findings: amyloid-related imaging abnormality-edema/effusion (ARIA-E) and amyloid-related imaging abnormality-hemosiderin deposition (ARIA-H)
    8. Nature, frequency, severity, and timing of injection-site reactions (ISRs)
    9. Presence of anti-drug antibodies (ADAs) during the study relative to the presence of ADAs at baseline
    10. Change in brain amyloid load over time, as measured by amyloid positron emission tomography (PET) in a subset of participants
    11. Change in brain tau load over time, as measured by tau PET in a subset of participants
    12. Change in cerebrospinal fluid (CSF) biomarkers, including, but not limited to, Aβ1-42, Aβ1-40, NfL, pTau, and tTau in a subset of participants
    13. Change in blood-based biomarkers biomarkers, including, but not limited to, Aβ1-42, Aβ1-40, NfL, pTau, and tTau in a subset of participants
    14. Change in magnetic resonance imaging (MRI)-derived measurements over time, including, but not limited to, volumetric changes in whole-brain, ventricles, hippocampus, or other structures in all participants
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Baseline to Year 4 (Week 211)
    5-9. Baseline to Week 227 (or 15 weeks after Early Term Visit) (Note: The primary comparison for safety will be between active gantenerumab and placebo)
    10-14. For CSF and PET: Baseline to week 211/For MRI: Baseline to Week 227 (or 15 weeks after Early Term Visit)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    E.8.2.3.1Comparator description
    Control arm: pts randomized to pcb + pts randomised to pcb and starting active tx (ref protocol 4.1
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    Argentina
    Australia
    Belgium
    Canada
    France
    Germany
    Ireland
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    A participant is considered to have completed the study if he or she has completed all phases of the study, including the safety FU visit shown in the schedule of activities (see Section 1.3). The end of this study is defined as the date of the LPLV in the study or the date at which the last data point required for safety analyses or safety FU is received from the last participant, whichever occurs later. The end of the study is expected to occur 227 weeks after the last participant randomized.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 900
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 410
    F.4.2.2In the whole clinical trial 1200
    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 offer continued access to gantenerumab free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in the Protocol section 6.6.
    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 Decision2022-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-24
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