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    Summary
    EudraCT Number:2018-003985-15
    Sponsor's Protocol Code Number:APD334-301
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2018-003985-15
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE UC 52
    A.4.1Sponsor's protocol code numberAPD334-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03945188
    A.5.4Other Identifiers
    Name:IND numberNumber:125154
    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 SponsorArena Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 supportArena Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointSnehal Naik
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego - CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018582103647
    B.5.6E-mailsnaik@arenapharm.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 nameEtrasimod
    D.3.2Product code APD334
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.3Other descriptive nameAR401959 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis a form of inflammatory bowel disease.
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045366
    E.1.2Term Ulcerative colitis, unspecified
    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 efficacy of etrasimod on clinical remission in subjects with moderately to severely active ulcerative colitis (UC) after 12 and 52 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Secondary:
    The secondary objective is to assess the efficacy of etrasimod on clinical response, symptomatic response and remission, endoscopic changes, corticosteroid-free remission, and mucosal healing in subjects with moderately to severely active UC at time points up to 52 weeks of treatment.

    Safety:
    The safety objective is to assess the long-term safety of etrasimod after daily doses of 2 mg for up to 52 weeks in subjects with moderately to severely active UC.

    Other:
    Other objectives include evaluation of etrasimod pharmacokinetics (PK) and the effect of etrasimod on health-related subject-reported outcomes and biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women 16 to 80 years of age, inclusive, at the time of assent/consent. Enrollment of subjects < 18 years should be conducted only if acceptable according to local law and regulations
    2. Ability to provide written informed consent or assent and to be compliant with the schedule of protocol assessments
    3. Diagnosed with UC ≥ 3 months prior to screening confirmed by endoscopic and histologic evidence
    4. Active UC confirmed by endoscopy with ≥ 10 cm rectal involvement. Subjects with proctitis only at baseline who meet the other eligibility criteria for inclusion, including the endoscopic and rectal bleeding criteria for moderate to severe disease, will be capped at 15% of the total subjects
    5. Moderately to severely active UC defined as MMS of 4 to 9, including an ES of ≥ 2 and RB score ≥ 1
    6. Received a surveillance colonoscopy within 12 months before baseline. Subjects without a surveillance colonoscopy within the prior 12 months will have a colonoscopy at screening (ie, in place of screening proctosigmoidoscopy).
    7. Demonstrated an inadequate response to, loss of response to, or intolerance to at least 1 of the following therapies:
    a. Corticosteroids
    b. Thiopurines
    Biologic therapy or JAK inhibitor therapy
    a. Antitumor necrosis factor alpha (TNFα) antibodies
    b. Anti-integrin antibodies
    c. Anti-Interleukin 12/23 antibodies (eg, ustekinumab)
    d. JAK inhibitors
    Concomitant treatments:
    8. Subjects are permitted to be receiving a therapeutic dose of the following drugs:
    - Oral 5-ASA compounds provided the dose has been stable for ≥ 2 weeks immediately prior to randomization
    - Oral corticosteroid therapy (prednisone at a stable dose ≤ 20 mg/day, budesonide at a stable dose ≤ 9 mg/day, or equivalent steroid provided the dose has been stable for the 4 weeks immediately prior to the screening endoscopy assessment
    - Immunosuppressive agents such as oral azathioprine or 6-mercaptopurine must be discontinued ≥ 2 weeks prior to randomization
    - Probiotics (eg, Culturelle®, Saccharomyces boulardii) provided the dose has been stable for the 2 weeks immediately prior to randomization
    If oral 5-ASA or corticosteroids have been recently discontinued, they must have been stopped for at least 2 weeks prior to the endoscopy used for the baseline MMS.
    9.Adequate hematological function defined by white blood cell count ≥ 3.5 × 109/L with absolute neutrophil count (ANC) ≥ 1.5 × 109/L, lymphocyte count ≥ 0.8 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 8 g/dL
    10.Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.0 × ULN. Subjects with an isolated total bilirubin and normal AST and ALT diagnosed with Gilbert’s syndrome may participate
    11. Adequate renal function defined by an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 by the CKD epidemiology
    collaboration equation at screening
    12. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
    a. A female who is not of childbearing potential must meet 1 of the following:
    − Postmenopausal, defined as no menses for 12 months without an alternative medical cause;
    − Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
    b. Non-pregnant female of childbearing potential must agree to using a highly effective contraception method during treatment and for 30 days following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly. The following are considered highly effective birth control methods:
    − Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal
    − Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted
    − Intrauterine device (IUD)
    − Intrauterine hormone-releasing system
    − Bilateral tubal occlusion
    − Vasectomized partner, provided that partner is the sole sexual partner of the WOCBP trial subject and that the vasectomized partner has received medical assessment of the surgical success.
    − Sexual abstinence. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence is not acceptable.
    c. A male subject with a pregnant or non-pregnant female of
    childbearing potential partner must agree to using condoms during treatment and for 4 weeks following treatment
    E.4Principal exclusion criteria
    1. Severe extensive colitis as evidenced by
    Physician judgment that subject is likely to require hospitalization for medical care or surgical intervention for UC within 12w following
    randomization
    Current evidence of fulminant colitis, toxic megacolon or recent history (last 6months) of toxic megacolon or bowel perforation
    Previous total or partial colectomy
    2. Diagnosis of CD or indeterminate colitis or the presence or history of a fistula consistent with CD
    3. Diagnosis of microscopic colitis, ischemic colitis or infectious colitis
    4. Hospitalization for exacerbation of UC requiring IV steroids within 12w of screening
    5. Positive assay or stool culture for pathogens or positive test for Clostridioides difficile toxin at screening
    6. Pregnancy, lactation or a +ve serum β-hCG at screening
    7. Clinically relevant neurological, endocrine, metabolic, psychiatric, cognitive impairment, alcohol/drug abuse/dependence or other major
    systemic disease making implementation of the protocol or interpretation of the study difficult or would put the subject at risk
    8. Have any of the following conditions or receiving treatments that may affect cardiovascular function
    Myocardial infarction, unstable angina, stroke/transient ischemic attack, decompensated heart failure requiring hospitalization or Class III/IV heart failure ≤ 6m prior or during Screening period
    History or presence of second-degree or third-degree atrioventricular block, sick sinus syndrome or periods of asystole for > 3 seconds without functional pacemaker
    History or presence of recurrent symptomatic bradycardia or recurrent cardiogenic syncope
    Screening or W0/Day 1 prerandomization vital signs with a heart rate <50bpm OR systolic blood pressure <90mm Hg OR diastolic BP <55mm Hg
    Screening or W0/Day 1 prerandomization ECG with PR interval >200ms
    or Fridericia's corrected QT interval ≥450ms in men or ≥470ms in women
    Start, stop, change or planned change in dosage of any anti-arrhythmic drugs (Class I to V) ≤1w b4 screening or within 1w b4 or after randomization
    9. Forced expiratory volume @ 1 second or forced vital capacity <70% of predicted values & FEV1/FVC ratio <0.70 at screening
    10. Uncontrolled diabetes determined by hemoglobin A1c (HbA1c) >9% at screening or subjects with diabetes with significant comorbid conditions
    11. History of macular edema or retinopathy
    12. History of active tuberculosis, history of untreated or inadequately treated latent TB infection, active or latent TB infection at screening
    13. clinically significant active infection ≤28d prior to randomization, required IV medication ≤14d prior to randomization or that may worsen
    14. Have HIV/acquired immune deficiency syndrome or test positive for HIV antibodies
    15. Have acute or chronic hep B infection or test positive for hepatitis B virus at screening (detectable HBV DNA or positive for hepB surface antigenor negative for HBsAg & positive for antihepatitis B core antibody in conjunction with detectable HBV DNA or detectable HBV DNA)
    16. Have current hepC infection or test +ve for hepC virus (HCV)
    17. History of an opportunistic infection or history of disseminated herpes simplex or disseminated herpes zoster
    18. History of or currently active primary or secondary immunodeficiency
    19. History of cancer within the last 5y including solid tumors & haematological malignancies (except basal cell & in situ squamous cell carcinomas of the skin that have been excised and resolved) or colonic mucosal dysplasia
    20. History of lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorder or multiple myeloma
    21. Hypersensitivity to etrasimod or any of the excipients or placebo compounds
    22. Prior treatment with S1P receptor modulators
    23. Treatment with a biologic agent ≤8w or a small molecule agent ≤5
    elimination half-lives & detectable drug level prior to randomization
    24. Treatment with an investigational therapy ≤3m prior to randomization
    25. Treatment with ≥ 3 biologic agents or ≥ 2 biologics plus a JAK inhibitor approved for UC
    26. Treatment with topical rectal 5-ASA, short-chain fatty acid enemas, or steroids ≤2w prior to & during screening
    27. Treatment with topical rectal traditional medicine (eg, Chinese medicine), herb enemas or suppositories ≤2w prior to randomization
    28. Treatment with methotrexate ≤8w prior to & during screening or cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil ≤16w prior to & during screening
    29. Receipt of live vaccine ≤4w before randomization
    30. Previous treatment with natalizumab
    31. Previous treatment with lymphocyte-depleting therapies
    32. Previous treatment with D-penicillamine, thalidomide, dimethyl fumarate or pyrimidine synthesis inhibitors
    33. Treatment with IV immune globulin or plasmapheresis, ≤3m prior to randomization
    34. Chronic use of therapies that moderately/strongly inhibit/induce cytochrome P450 (CYP) 2C8 & 2C9 metabolism & inhibitors of UGT1A7 ≤ 4w before randomization
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoints will evaluate etrasimod versus placebo in:
     The proportion of subjects achieving clinical remission at Week 12
     The proportion of subjects achieving clinical remission at Week 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 & Week 52
    E.5.2Secondary end point(s)
    The key secondary efficacy endpoints are:
    The proportion of subjects achieving endoscopic improvement at Week 52
    The proportion of subjects achieving endoscopic improvement at Week 12
    The proportion of subjects achieving symptomatic remission at Week 52
    The proportion of subjects achieving symptomatic remission at Week 12
    Proportion of subjects in clinical remission at w52 & who had not been receiving corticosteroids for ≥12 weeks prior to w52
    Proportion of subjects with mucosal healing at Week 52
    Proportion of subjects with mucosal healing at Week 12
    Proportion of subjects achieving clinical remission at both Weeks 12 and 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 52 and 2 & 4 weeks follow-up
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    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 EEA253
    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
    Austria
    Belarus
    Belgium
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czechia
    Denmark
    Egypt
    Estonia
    France
    Georgia
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Mexico
    Moldova, Republic of
    Netherlands
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 Yes
    F.1.1Number of subjects for this age range: 15
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 167
    F.4.2.2In the whole clinical trial 420
    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. However eligible participants will be given the opportunity to enter an open label extension study (OLE) with etrasimod
    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 Decision2019-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-16
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