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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   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:2022-002378-95
    Sponsor's Protocol Code Number:D7000C00001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-27
    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 ConcernedFrance - ANSM
    A.2EudraCT number2022-002378-95
    A.3Full title of the trial
    A Phase I/III Randomized, Double blind Study to Evaluate the Safety and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants with Conditions Causing Immune Impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase I/III study to assess pre-exposure prophylaxis of AZD5156/AZD3152 in immunocompromised individuals
    A.3.2Name or abbreviated title of the trial where available
    SUPERNOVA
    A.4.1Sponsor's protocol code numberD7000C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05648110
    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 AB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street Address151, 85 Södertälje
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE-151 85
    B.5.3.4CountrySweden
    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 nameAZD3152
    D.3.2Product code AZD3152
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZD3152
    D.3.9.1CAS number 2768288-97-5
    D.3.9.2Current sponsor codeAZD3152
    D.3.9.3Other descriptive namemonoclonal antibody
    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 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 EVUSHELD™
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecilgavimab
    D.3.2Product code AZD1061
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCilgavimab
    D.3.9.1CAS number 2420563-99-9
    D.3.9.2Current sponsor codeAZD1061
    D.3.9.3Other descriptive namemonoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 3
    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 EVUSHELD™
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTixagevimab
    D.3.2Product code AZD8895
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTixagevimab
    D.3.9.1CAS number 2420564-02-7
    D.3.9.2Current sponsor codeAZD8895
    D.3.9.3Other descriptive namemonoclonal antibody (mAb)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Cohort
    1.To evaluate the safety of AZD3152 and AZD7442
    2.To compare the nAb responses to the SARS-CoV-2 Alpha variant in serum following AZD3152 and AZD7442 administration
    Sentinel Safety Cohort
    1.To evaluate the safety of AZD5156
    E.2.2Secondary objectives of the trial
    Main Cohort
    1..To compare the efficacy of AZD3152 to AZD7442 in the prevention of symptomatic COVID-19
    2.To compare the nAb responses to the SARS-CoV-2 Omicron variant BA.4/5 and the emerging dominant variant of concern circulating during the course of the study in serum following AZD3152 and AZD7442 administration
    3.To describe the incidence of symptomatic COVID-19, severe COVID-19, COVID-19 related hospitalization, and COVID-19 related death in participants receiving study intervention
    4.To characterize the PK of AZD5156 and AZD7442 in serum
    5.To evaluate the ADA responses to AZD3152 and AZD7442 in serum
    Sentinel Safety Cohort
    1.To characterize the PK of AZ5156 and AZD3152 in serum
    2.To evaluate the ADA responses to AZD5156, AZD3152 and AZD1061 in serum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sentinel Safety Cohort Participants (Phase I)
    Participants are eligible to be included in the Part A Sentinel Safety Cohort only if all of the following criteria apply:
    1.Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol).
    2.Age 18 to 55 years at the time of signing the informed consent.
    3.Negative rapid antigen test at Visit 1.
    4.Weight ≥ 45 kg and ≤ 110 kg at screening.
    Main Cohort Participants (Phase III)
    Participants are eligible to be included in the Part A Main Cohort only if all of the following criteria apply:
    1.Participant must be 12 years of age or older at the time of signing the informed consent.
    2.Negative rapid antigen test at Visit 1 and Visit 5.
    3.Weight ≥ 40 kg at Visit 1 and Visit 5.
    4.Participants must satisfy at least 1 of the following risk factors at enrollment:
    •Have solid tumor cancer and be on active treatment except for adequately treated:
    Non-melanoma skin cancer or lentigo maligna
    Uterine cervical carcinoma in situ
    Local prostate carcinoma
    •Have hematologic malignancy
    •Have solid organ transplant or a hematopoietic stem cell transplant (within 2 years of transplantation, are taking immunosuppression therapy or who have chronic graft versus-host disease)
    •Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks], high dose alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg, Bruton’s tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive or immunomodulatory biologic agents for rheumatic diseases)
    •Received chimeric antigen receptor T cell therapy
    •Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab)
    •Have a moderate or severe primary immunodeficiency (eg, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe combined immunodeficiency, common variable immunodeficiency, agammaglobulinemia)
    5.Medically stable defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment.
    E.4Principal exclusion criteria
    Sentinel Safety Cohort Participants (Phase I)
    Participants are excluded from the Part A Sentinel Safety Cohort if any of the following criteria apply:
    1.Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention adm and until at least 6 months after study intervention adm (see details in CSP)
    2.Known hypersensitivity to any component of the study intervention.
    3.Previous hypersensitivity or severe adverse reaction following admof a mAb.
    4.Acute (time-limited) or febrile (temperature ≥ 38.0°C illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
    5.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
    6.Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM inj or venipuncture.
    7.Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1
    8.Previous receipt of a mAb against SARS-CoV-2.
    9.Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
    10.Receipt of a COVID-19 antiviral for prophylaxis within at least 2
    weeks prior to Visit 1
    11.COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]).
    Main Cohort Participants (Phase III)
    Participants are excluded from the Part A Main Cohort if any of the following criteria apply:
    1.Women who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential(see details in CSP)
    2.Known hypersensitivity to any component of the study intervention.
    3.Previous hypersensitivity or severe adverse reaction following administration of a mAb.
    4.Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
    5.Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
    6.Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
    7.Has HIV infection.
    8.Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.
    9.Previous receipt of a mAb against SARS CoV 2 within 6 months prior to Visit 1.
    10.Receipt of a COVID-19 vaccine within 3 months prior to Visit 1
    11.Receipt of a COVID-19 antiviral within at least 2 weeks prior to Visit 1
    12.COVID-19 within 6 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test including at-home testing).
    13. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study
    E.5 End points
    E.5.1Primary end point(s)
    Main Cohort
    1.Occurrence of AEs collected through 90 days after IMP administration; SAEs, MAAEs and AESIs collected throughout the study
    2.GMTs for SARS-CoV-2 Alpha variant nAbs
    Sentinel Safety Cohort
    1.Occurrence of AEs collected through 90 days after IMP administration; SAEs, MAAEs, and AESIs collected through the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through 90 days after IMP administration
    E.5.2Secondary end point(s)
    1.Time from the first dose of IMP to the first occurrence of a
    symptomatic COVID-19 case which is defined as:
    •Negative RT-PCR at baseline to positive at any time up to Visit 9
    (12months) AND
    •Satisfying modified WHO definition of symptomatic COVID-19
    2.Geometric mean titer (GMT) and geometric mean fold rise (GMFR) ratio of SARS-CoV-2 nAbs between the treatment arms at Visit 3 (Day 29).
    3.Incidence of a post treatment:
    •Symptomatic COVID 19 case (negative RT PCR at baseline to positive at any time up to 6 and 12 months)
    •Severe COVID-19
    •Composite of COVID-19 related hospitalization and/or COVID-19 related death
    •COVID-19 related hospitalization (separately)
    •COVID 19 related death (separately)
    4. AZD3152, AZD7442, AZD1061, and AZD8895 concentrations over time and PK parameters
    In the Main Cohort: AZD5156, and AZD7442, AZD1061, AZD3152, and AZD8895 concentrations over time
    5.Incidence of ADA
    Sentinel Safety Cohort
    1.AZD5156, AZD1061, and AZD3152 concentrations over time and PK
    parameters
    2.Incidence of ADA
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Visit 3 (Day 29)
    Through the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Canada
    Israel
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    Philippines
    Taiwan
    Thailand
    United States
    Turkey
    Belgium
    Denmark
    France
    Germany
    Poland
    Spain
    Sweden
    United Kingdom
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 488
    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: 488
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2279
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 489
    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 No
    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 state226
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 747
    F.4.2.2In the whole clinical trial 3256
    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 Decision2023-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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