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    Summary
    EudraCT Number:2018-004175-12
    Sponsor's Protocol Code Number:B7931028
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-07-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2018-004175-12
    A.3Full title of the trial
    A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus
    A.4.1Sponsor's protocol code numberB7931028
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03845517
    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 SponsorPfizer 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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-06700841
    D.3.2Product code PF-06700841 5mg
    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 INNPF-06700841
    D.3.9.2Current sponsor codePF-06700841
    D.3.9.3Other descriptive namePF-06700841-15
    D.3.9.4EV Substance CodeSUB184971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 namePF-06700841
    D.3.2Product code PF-06700841 25mg
    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 INNPF-06700841
    D.3.9.2Current sponsor codePF-06700841
    D.3.9.3Other descriptive namePF-06700841-15
    D.3.9.4EV Substance CodeSUB184971
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Systemic Lupus Erythematosus (SLE)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Erythematosus (SLE) is a chronic inflammatory disease
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 3 once daily (QD) dose levels of PF-06700841 compared to placebo in participants with active SLE.
    E.2.2Secondary objectives of the trial
    - To assess time to first severe flare in PF-06700841 treated participants relative to placebo.
    - To assess attainment of low disease activity state of 3 QD dose levels of PF-06700841 compared to placebo in participants with active SLE.
    - To compare the corticosteroid use (prednisone or equivalent) in PF-06700841 treated participants relative to placebo.
    - To evaluate the efficacy of PF-06700841 compared to placebo in participants with active SLE and with sustained reduction of oral corticosteroids.
    - To evaluate the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score in the subset of participants with baseline CLASI-A score >10 in PF-06700841 treated participants relative to placebo.
    - To evaluate the effect on fatigue of PF-06700841 treated participants relative to placebo.

    Please refer to protocol B7931028 section 3 for a full list of secondary objectives.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female participants between the ages of 18 (or the minimum country specific age of consent if >18) and 75 years, inclusive, at the time of signing the informed consent document (ICD).
    o Refer to Appendix 4 for reproductive and contraceptive criteria for male and female participants.
    • Have a clinical diagnosis of SLE according to the 1997 update on the 1982 revised American College of Rheumatology (ACR) Criteria for the Classification of SLE see Appendix 8 OR meet at least 4 of the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria see Appendix 9, including at least 1 clinical criterion and 1 immunologic criterion, at least 6 months prior to dosing of study agent.
    • Have serologically positive SLE at the screening visit based on 1 of the following test results from the central laboratory during the screening period:
    o ANA titer ≥1:80, or
    o Positive anti dsDNA.
    Note: The ANA and/or anti double stranded DNA (anti-dsDNA) measurement may be repeated once at the central laboratory within approximately 2 weeks of the initial value, and the value resulting from repeat testing may be accepted for enrollment eligibility if it meets the eligibility criterion.
    • All participants must be currently receiving EITHER a stable dose of an immunosuppressant [methotrexate (MTX), azathioprine(AZA)/6-mercaptopurine (6-MP), leflunomide, mizoribine, mycophenolate/mycophenolic acid(MMF)] with or without antimalarials and/or corticosteroids, OR anti-malarials (hydroxychloroquine or chloroquine) in combination with corticosteroids. Antimalarial or steroid monontherapy is not permitted. Participants may not be receiving combinations of 2 or more immunosuppressants.
    Note: Stable dose is defined as no new therapy or change in standard-of-care therapies as above within 12 weeks of Day 1 for immunosuppressives or within 2 weeks of Day 1 for corticosteroids . See Appendix 13 for allowable stable doses.
    • Have active disease defined as:
    o SLEDAI 2K score of ≥8 points at screening, and “Clinical” SLEDAI 2K score of ≥4 points at both screening and randomization
    NOTE: "Clinical" SLEDAI 2K score (See Appendix 11) is the SLEDAI 2K score without the inclusion of points attributable to any urine or laboratory results including immunologic measures. For inclusion in the study, the Clinical SLEDAI-2K calculation for entry will exclude points for a) Lupus Headache, b) skin disease involving Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Erythema scores less than 2 and c) arthritis scores must involve a minimum of 3 joints with tenderness, swelling, or effusion (ie rather than 2).
    AND
    o BILAG Level A disease in ≥1 organ system (except renal or central nervous system [CNS]) or BILAG B disease in ≥2 organ systems if no level A disease is present at screening. At least one A or one B level body system grade must be in the Mucocutaneous or Musculoskeletal systems. A qualifying screening Mucocutaneous B due to BILAG #6, mild skin eruption, must have a CLASI erythema activity score of >=2. A qualifying screening Musculoskeletal B due to #42, moderate arthritis, must show >=3 swollen, tender joints and a qualifying Musculoskeletal A score due to #41, severe arthritis, must show >=6 tender, swollen joints on the screening joint count. (see Appendix 12).
    Note: Data from the SLICC, SLEDAI and BILAG evaluations will be reviewed by the Sponsor and/or the Sponsor-selected independent reviewer(s). For participants to receive their first administration of study agent, approval must be received by the Sponsor and/or Sponsor-selected independent reviewers.

    See section 5.1 of the Protocol for a full list of Inclusion Criteria
    E.4Principal exclusion criteria
    • Have active renal lupus as defined by the following: spot urine protein/creatinine ratio >3.0 mg/mg (proteinuria >3.0 g/24 hours may also be used if available) or have BILAG A renal disease, or have required hemodialysis or active urinary sediment with red blood cell cast(s), or histological evidence (if available) of diffuse proliferative glomerulonephritis within the 12 weeks prior to screening.
    o Note: The lab measurements related to lupus nephritis may be repeated once within approximately 2 weeks of the initial values, and the values resulting from repeat testing may be accepted for enrollment eligibility if they meet the eligibility criteria.
    • Have severe active central nervous system (CNS) lupus (eg, BILAG A neurological disease and/or active, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia or dementia related to SLE, psychosis, organic brain syndrome, cerebrovascular accident [CVA], cerebritis or CNS vasculitis) requiring therapeutic intervention within 60 days of Day 1. Participants with BILAG B level neurologic disease are not excluded as long as they meet all other qualifying criteria for the study.
    • Have cancer or a history of cancer (other than adequately resected cutaneous basal cell, squamous cell carcinoma, or carcinoma in situ of the uterine cervix with no evidence of recurrence within the previous 3 years). If a participant is followed for a history of cancer that is consider treated and cured, a note from the oncologist, or specialist following the participant for recurrence should be available in the source document. Additionally, the participant is required to comply with recommended follow up testing with their specialist of record while participating in the study.
    • The following is exclusionary;
    - Any history of thrombosis (venous or arterial) or cerebrovascular ischemic event (stroke or transient ischemic attack [TIA]) within the last 6 months.
    - A history of a ischemic cerebrovascular event (stroke, TIA) within the past 12 months unless these were caused by known antiphospholipid syndrome and the patients has been adequately anticoagulated (and will continue on anticoagulation per guidelines) according to current guidelines for at least 6 months without a recurrence of any thrombotic event.
    - Any history of a pulmonary embolus, unless these were caused by known antiphospholipid syndrome and the patients has been adequately anticoagulated (and will continue on anticoagulation per guidelines) according to current guidelines for at least 6 months without a recurrence of any thrombotic event.
    Note. Any participant being treated for antiphospholipid syndrome or anticardiolipin antibodies must be adequately anticoagulated according to current local guidelines. Sites should make every effort to obtain a medical history of at least 3 years duration to document that there have been no thrombotic events or an obstetrical history of repeat fetal losses. In the absence of this medical history information, a hematology consult may be required if antiphospholipid screening tests are positive.
    • Active bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, allergic aspergillosis or cavitary lung lesions or granulomatous disease on chest x ray). History of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to TB and atypical mycobacterial disease, granulomatous disease on chest x ray) that would substantially increase the risk to the participant if he or she participates in the study.

    See section 5.2 of the Protocol for a full list of Exclusion Criteria
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving the Systemic Lupus Erythematosus Responder Index (SRI) change of 4 (SRI 4) at Week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    • Time to first severe flare as measured by the modified Safety of Estrogen in Lupus: National Assessment (SELENA) Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) SLE Flare Index (SELENA SLEDAI SFI).
    • Proportion of participants achieving the Lupus Low Disease Activity State (LLDAS) at Week 52.
    • Proportion of participants achieving a reduction in prednisone (or equivalent) dose to ≤ 7.5 mg/day and sustained for 12 weeks at Week 52, in the subset of participants on prednisone >7.5 mg/day (or equivalent) at baseline.
    • Proportion of participants achieving SRI-4 response with dose of prednisone (or equivalent) reduced to ≤7.5 mg/day and sustained for 12 weeks at Week 24 and Week 52, in the subset of participants with prednisone dose >7.5 mg/day (or equivalent) at baseline.
    • Proportion of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI-A Total Activity Score.
    • Change from baseline in the total scores of Functional Assessment of Chronic Illness Therapy Fatigue (FACIT F) at Week 52.
    • Change from baseline in the individual domain scores of the Lupus Quality of Life (LupusQoL) at Week 52.
    • Incidence of treatment-emergent adverse events (AE’s)
    • Incidence of serious AE’s (SAEs) and AE’s leading to discontinuation.
    • The incidence of clinically significant abnormalities in vital signs and ECGs.
    • The incidence of clinically significant abnormalities in clinical laboratory values.

    Separate blinded, independent adjudication committees will be responsible for the ongoing review and adjudication of the following efficacy and safety endpoints: 1) BILAG, SLEDAI and associated data; 2) Severe Flare; 3) Cardiovascular and thromboembolic events; 4) Malignancy; and 5) Opportunistic infections.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Individual timepoints are included in each secondary endpoint bullet point above.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 trial4
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belgium
    Bulgaria
    Canada
    China
    Colombia
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Hungary
    Japan
    Korea, Republic of
    Mexico
    Poland
    Portugal
    Romania
    Serbia
    Spain
    Taiwan
    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 months7
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days20
    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: 403
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 158
    F.4.2.2In the whole clinical trial 448
    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 Decision2019-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-30
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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