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    Summary
    EudraCT Number:2011-002068-26
    Sponsor's Protocol Code Number:BEL115123
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-05
    Trial results View 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 number2011-002068-26
    A.3Full title of the trial
    A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)

    A.4.1Sponsor's protocol code numberBEL115123
    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 SponsorGlaxoSmithKline Research & Development 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 supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)208990 4466
    B.5.5Fax number+44(0)208990 1234
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 Yes
    D.2.1.1.1Trade name BENLYSTA® (belimumab)
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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 nameBenlysta (belimumab)
    D.3.2Product code GSK1550188
    D.3.4Pharmaceutical form Powder for 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 INNbelimumab
    D.3.9.1CAS number 356547-88-1
    D.3.9.2Current sponsor codeGSK1550188
    D.3.9.4EV Substance CodeSUB25607
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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) Yes
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myasthenia Gravis
    E.1.1.1Medical condition in easily understood language
    Myasthenia Gravis
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10028417
    E.1.2Term Myasthenia gravis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of belimumab in subjects with MG by testing the hypothesis that belimumab will be more effective than placebo in reducing signs of MG as measured by the Quantitative Myasthenia Gravis (QMG) score.
    E.2.2Secondary objectives of the trial
    • To further assess efficacy of belimumab in subjects with MG
    • To assess safety, tolerability, and pharmacodynamics of belimumab in subjects with MG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects eligible for enrolment in the study must meet all of the following criteria:
    1. Subjects aged 18 years and older, with life expectancy of greater than 1 year.
    2. MG of class II to IVa inclusive.
    3. Acetylcholine receptor (AChR) or muscle-specific kinase (MuSK)antibody positive.
    4. Stable dose (defined as no dose changes) not exceeding the maximum doses given in Section 5.6.1 of protocol, the following therapy(ies) prior to screening:
    A. Cholinesterase inhibitor(pyridostigmine or equivalent) for at least 2 weeks prior to screening and no immunosuppressants;
    or
    B. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening and/or only one of the following:
    i. prednisone (up to 40 mg/day or equivalent) for at least 1 month prior to screening,
    ii. azathioprine for at least 6 months prior to screening,
    iii. mycophenolate for at least 6 months prior to screening,
    iv. cyclosporine for at least 3 months prior to screening;
    v. methotrexat for at least 3 months prior to screening
    or
    C. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening and/or prednisone (up to 20 mg/day or
    equivalent) for at least 1 month prior to screening and only one of the following:
    i. azathioprine for at least 6 months prior to screening,
    ii. mycophenolate for at least 6 months prior to screening,
    iii. cyclosporine for at least 3 months prior to screening
    iv. methotrexat for at least 3 months prior to screening
    5. Quantitative Myasthenia Gravis (QMG) score of 8 or greater, with at least 4 points derived from signs other than ocular
    6. A female subject is eligible to participate if she is:
    A. Of non-childbearing potential
    B. Of childbearing potential and NOT pregnant or nursing, has a negative serum
    pregnancy test at screening, and agrees to one of the following:
    a. Complete abstinence from penile-vaginal intercourse, when this is the
    female’s preferred and usual lifestyle, for the period from consent into the study until 16 weeks after the last dose of investigational product; or,
    b. Consistent and correct use of one of the following acceptable methods of
    birth control for the period from consent into the study until 16 weeks
    after the last dose of investigational product:
    i. Oral contraceptives (either combined or progesterone only)
    ii. Injectable progesterone
    iii. Implants of etonogestrel or levonorgestrel
    iv. Estrogenic vaginal ring
    v. Percutaneous contraceptive patches
    vi. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of <1% per year
    vii. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study;
    this male must be the sole partner for the subject
    viii. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent(foam/gel/film/cream/suppository).
    A female is considered “Non-childbearing potential” if she is status-post hysterectomy,
    status-post surgical removal of both ovaries, has current, documented tubal ligation, or is
    postmenopausal and >2 years without menses. Female subjects who are post-menopausal
    <2 years must be confirmed menopausal by Follicle Stimulating Hormone (FSH) and
    estradiol levels.
    A female is considered “childbearing potential” if she has functional ovaries, ducts, and
    uterus with no impairment that would cause sterility. This includes women with oligomenorrhea (even severe), and women who are perimenopausal or who have just
    begun to menstruate.
    7. Capable of giving written informed consent, which includes compliance with the
    requirements and restrictions listed in the consent form.
    8. Single QTc < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
    9. AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin > 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
    French subjects: In France, a subject will be eligible for inclusion in this study only if
    either affiliated to or a beneficiary of a social security category.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    1. The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to screening or planning to take any investigational drug for the planned duration of study participation (6
    months after the last dose of study drug).
    2. Presence or previous history of thymoma.
    3. Thymectomy within 12 months
    4. Clinically significant (in the opinion of investigator) abnormal laboratory values.
    5. Pregnant females as determined by positive (serum) hCG test at screening or prior to dosing, or lactating females or planning to become pregnant within 16 weeks after last dose of investigational product.
    6. History of sensitivity to any of the study medications, or components thereof or a
    history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    7. May require (in the opinion of investigator) treatment with IVIg and/or plasmapheresis during the 12 weeks after the screening visit.
    8. Have received IVIg and/or plasmapheresis within 4 weeks prior to screening.
    9. Have received any other biopharmaceutical agent (except IVIg as described in exclusion criteria #8) in the 364 days prior to screening.
    10. Have received treatment with rituximab within 12 months prior to screening or have received treatment with belimumab or any other B cell targeted therapy at any time.
    11. Have received a live vaccine within 30 days of study Day 0 (baseline).
    12. Have received cyclophosphamide or any other immunosuppressive agent apart from
    the ones allowed by the inclusion criteria #4, within the past 6 months.
    13. Have another medical condition that requires treatment with steroids or immunosuppressive agents.
    14. Hospitalization due to infection or use of parenteral antibacterial, antifungal or antiviral agents within 60 days prior to screening; or history of recurrent or chronic infection, or currently active systemic infection.
    15. Have a history of malignant neoplasm within the last 5 years, except for adequately
    treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the
    uterine cervix.
    16. Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant.
    17. Have a historically positive test or test positive at screening for HIV-1, hepatitis B surface antigen, hepatitis B core antibody or hepatitis C antibody (Patients who are positive for hepatitis C antibody but negative for a confirmatory RNA test will be eligible to participate.)
    18. Have an IgG Grade 3 or greater deficiency (≤ 400mg/dL).
    19. Have an IgA deficiency (IgA < 10mg/dL).
    20. Have a history of an anaphylactic reaction to parenteral administration of contrast
    agents, human or murine proteins or monoclonal antibodies.
    21. The subject has a progressive medical, neurological or psychological condition or
    situation that, in the investigator’s judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures, to complete all scheduled assessments, or precludes accurate assessments.
    22. Is currently abusing drugs or alcohol or has history of abuse in the last 12 months.
    23. Subjects who have evidence of serious suicide risk including any history of suicidal
    behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the CSSRS (Appendix 4 of Protocol) in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change from baseline for QMG score at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    QMG Score:
    • Proportion of subjects with improvement by ≥ 3points from baseline to Week 24 in QMG score
    • Proportion of subjects with a sustained response (improve by ≥ 3 points from baseline to Week 12 and maintain the response through Week 24) in the QMG score
    • Proportion of subjects with a worsening by ≥ 3 points in QMG score from baseline to Week 24
    • Median time to QMG response which is sustained (from earliest time point at which
    improvement by ≥ 3 points from baseline is observed and maintained through Week 24)
    • Mean change from baseline for QMG score at Week 28, Week 32, and Week 36.

    MG Composite (MGC) Score:
    • Mean change from baseline in MGC at Week 24
    • Proportion of subjects with improvement by ≥ 3points from baseline to Week 24 in the MG Composite (MGC) score
    • Proportion of subjects with a sustained response (improve by ≥ 3 points from
    baseline to Week 12 and maintain the response through Week 24) in MGC score
    • Proportion of subjects with a worsening by ≥ 3 points in MGC score from baseline to Week 24
    • Median time to MGC score response which is sustained (from earliest time point at which improvement by ≥ 3 points from baseline is observed and maintained through Week 24)
    • Mean change from baseline for MGC score at Week 28, Week 32, and Week 36.

    Myasthenia Gravis Foundation of America (MGFA) Post-Intervention Status:
    • Proportion of subjects with a MGFA post-intervention status of Minimal Manifestation (MM) or better at Week 24 and Week 36
    • Proportion of subjects with MGFA post-intervention status of Pharmacologic Remission (PR) or better at Week 24 and Week 36
    • Proportion of subjects with a MGFA post-intervention status of MM sustained response (MM at Week 12 and maintained the response through Week 24)
    • Proportion of subjects with MGFA post-intervention status of PR sustained response
    (PR at Week 12 and maintained the response through Week 24)
    • Proportion of subjects with MGFA post-intervention status (Unchanged, Improved,
    Worsened) at Week 24
    MG Activities of Daily Living Scale (MG-ADL):
    • Mean change from baseline in the MG-ADL at Week 12 and Week 24
    • Mean change from baseline in the MG-ADL at Week 28, Week 32, and Week 36

    Other
    Pharmacokinetics:
    • Individual serum concentrations of belimumab at Day 0, Week 2, Week 8, Week 20, Week 24 and Week 28.

    Pharmacodynamics/biomarkers:
    • Change from baseline to Week 8, Week 24, Week 28 and to Week 36 in acetylcholine receptor (AChR/MuSK) antibody titre
    • Change from baseline to Week 8, Week 24, Week 28 and Week 36 in B cell and T cell subsets
    Safety
    • Frequency and severity of adverse events (AEs)
    • Frequency of serious adverse events (SAEs)
    • Percentage of subjects withdrawing due to AEs
    • Percentage of subjects with drug-related AEs
    • Change from baseline in vital signs.
    • Frequency of vital signs of clinical concern
    • Change from baseline in hematology and chemistry parameters.
    • Frequency of hematology and chemistry parameters of potential clinical concern
    • Percentage of subjects withdrawing from study due to MG worsening/exacerbation
    • Percentage of subjects withdrawing from the study due to MG improvement and the
    need to decrease dose of MG concomitant medications more than allowed per protocol.
    • Percentage of subjects that decrease dose of MG concomitant medications due to MG improvement (regardless of withdrawal status).
    • Incidence of positive immunogenicity demonstrating the presence of anti-belimumab
    antibodies.
    E.5.2.1Timepoint(s) of evaluation of this end point
    QMG:Mean change from baseline for QMG score at:
    wk4, wk8, wk12, wk16, wk20, wk24, wk28, wk32, wk36.
    MG Composite (MGC) Score:Mean change from baseline for MGC score at wk2, wk4, wk8, wk12, wk16, wk20, wk24, wk28, wk32, wk36.
    MGFA Post-Intervention Status: wk12, wk24, wk 36
    MG Activities of Daily Living Scale (MG-ADL):
    wk4, wk8, wk12, wk16, wk20, wk24, wk28, wk32, wk36.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA6
    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
    Germany
    Italy
    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
    last subject’s last safety visit (16 week post last dose)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 42
    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)
    Post-study treatment with belimumab will not be provided to subjects, as further
    determination of efficacy and safety is required in the MG population prior to exposing subjects for longer durations.
    Considerations for the post-study care of a subject’s medical conditions are the
    responsibility of the investigator.
    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 Decision2011-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-27
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