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    Summary
    EudraCT Number:2019-000817-35
    Sponsor's Protocol Code Number:M-14745-41
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-30
    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 number2019-000817-35
    A.3Full title of the trial
    An open-label, randomized, Phase IV study, to assess the efficacy and safety of tildrakizumab in patients with moderate to severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open-label, randomized, Phase IV study, to assess the efficacy and safety of tildrakizumab in patients with moderate to severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy
    A.3.2Name or abbreviated title of the trial where available
    TRANSITION study
    A.4.1Sponsor's protocol code numberM-14745-41
    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 SponsorAlmirall
    B.1.3.4CountrySpain
    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 supportAlmirall
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlmirall
    B.5.2Functional name of contact pointInternat. Clinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressLaureà Miró, 408-410
    B.5.3.2Town/ citySant Feliu de Llobregat
    B.5.3.3Post code08980
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932917403
    B.5.6E-mailsara.herrero.external@almirall.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 Illumetri
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    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 nameIllumetri
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTILDRAKIZUMAB
    D.3.9.1CAS number 1326244-10-3
    D.3.9.3Other descriptive nameTILDRAKIZUMAB
    D.3.9.4EV Substance CodeSUB130334
    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: 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 Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    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 nameSkilarence
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 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 Skilarence
    D.2.1.1.2Name of the Marketing Authorisation holderAlmirall, S.A.
    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 nameSkilarence
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe chronic plaque psoriasis
    E.1.1.1Medical condition in easily understood language
    Moderate to severe chronic plaque psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071117
    E.1.2Term Plaque psoriasis
    E.1.2System Organ Class 100000004858
    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 tildrakizumab treatment (as assessed by PASI 75) in moderate-to-severe plaque psoriasis patients who are non-responders to DMF
    E.2.2Secondary objectives of the trial
    - assess the efficacy of tildrakizumab treatment in moderate-to-severe plaque psoriasis patients who are non-responders to DMF:
    - PASI, BSA, PGA, scalp PGA, palmoplantar PGA
    - DLQI, Skindex-16, pruritus-VAS, MOSS
    - assess the safety, tolerability of tildrakizumab treatment in moderate-to-severe plaque psoriasis patients who are non-responders to DMF
    - assess the efficacy of DMF treatment in moderate-to-severe plaque psoriasis patients:
    - PASI, BSA, PGA, scalp PGA, palmoplantar PGA
    - DLQI, Skindex-16, pruritus-VAS, MOSS
    - explore patient’s adherence rate to DMF treatment in moderate-to-severe plaque psoriasis patients
    - assess the safety, tolerability of DMF treatment in moderate-to-severe plaque psoriasis patients
    Exploratory objectives (part 1, Germany subgroup)
    Compare efficacy, safety, tolerability, adherence rate between standard and simplified DMF dosing schemes after 16 w of treatment in moderate-to-severe plaque psoriasis patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand and comply with the requirements of the study and communicate with the Investigator, and written, signed and dated informed consent given before any study related activity is performed.
    2. Male or female, aged 18 years at the time of the Screening Visit.
    3. Diagnosed with chronic plaque psoriasis of at least 6 months prior to the Screening Visit, and has stable active plaque-type psoriasis (stable is defined as without clinically significant flares during the 12 weeks before the Baseline Visit).
    4. Moderate-to-severe plaque psoriasis at the Screening and Baseline visits as defined by PASI score of ≥ 10
    5. Complete record of at least the last 12 months prior to the Screening Visit of anti-psoriatic previous topical, phototherapy and non-biologic systemic treatments, if any.
    6. Candidate for systemic treatment for plaque psoriasis at the Screening Visit
    7. General good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the Investigator based upon results of medical history, laboratory results (within normal or clinically acceptable range limits) and physical examination (no clinical significant abnormal findings). Investigators are encouraged to consult with the Sponsor if there are questions regarding the significance of any out of range values.
    8. Unlikely to conceive, as indicated by at least one “yes” answer to the following questions:
    a. Patient is a male.
    b. Patient is a surgically sterilized female by hysterectomy or bilateral tubal ligation.
    c. Patient is a postmenopausal female ≥45 years of age with >1 year since last menses. If a patient is <45 years of age, or cessation of menses is more than 3 months and less than 1 year, follicle stimulating hormone must be documented as elevated into the postmenopausal range (>60 mIU/mL) at the Screening visit.
    d. Patient is a non-sterilized and pre-menopausal female using a highly effective medically accepted method of contraception, during the study period and for 4 or 17 weeks after the last dose of DMF or tildrakizumab, respectively.
    9. For female patients of child-bearing potential, a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit. Additionally, they must agree to have urine pregnancy tests while on study medication.
    E.4Principal exclusion criteria
    1. Female patients who are currently pregnant, who intend to become pregnant during the course of the study, or who are breastfeeding. Also if there is unwillingness/inability for the patients (women or men) to use appropriate measures of contraception (if necessary).
    2. Current forms of psoriasis other than chronic plaque-type (e.g. erythrodermic, guttate, or pustular psoriasis)
    3. Drug-induced psoriasis (i.e., a new onset or current exacerbation of psoriasis from beta-blockers, calcium channel blockers, or lithium) at the Screening Visit
    4. History or evidence of skin disease (atopic dermatitis, eczema) or conditions (scarring, open wounds) other than chronic plaque-type psoriasis that might interfere with the study conduct or evaluations, or which exposes the patient to unacceptable risk by study participation
    5. History of hypersensitivity or allergy to the study drugs or its excipients, which include lactose*
    * People with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not be included in the study.
    6. History of or concurrent malignancy (excluding successfully treated basal cell carcinoma, squamous cell carcinoma of the skin in situ, squamous cell carcinoma with no evidence of recurrence within 5 years or carcinoma in situ of the cervix that has been adequately treated).
    7. History of or current relevant autoimmune diseases (e.g. lupus-like syndromes) other than psoriasis.
    8. Active significant gastrointestinal problems (ulcers, diarrhoea, etc.) at the Screening Visit
    9. Severe renal impairment (creatinine clearance <30 mL/min, estimated glomerular filtration rate [eGFR] using CKD-EPI Creatinine Equation) or significant proteinuria (3+ or higher measured by dipstick) at the Screening Visit.
    10. Any of the following haematological abnormality at the Screening Visit:
    a. Platelet count < 100,000/mm3
    b. White blood cell count < 3,000 cells/mm3,
    c. Lymphocyte count <1.000/μl,
    d. Haemoglobin, haematocrit, or red blood cell count outside 30 % of the upper or lower limits of normal for the laboratory
    11. Abnormal liver enzymes at the Screening Visit:
    a. If an enzyme was >3x the upper limit of the normal range (ULN): aspartate amino transferase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine amino transferase (ALT; serum glutamic pyruvic transaminase [SGPT]), gamma-glutamyl-transferase (GGT), alkaline phosphatase (ALP)
    b. If bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary
    12. Active infectious disease at the Screening Visit
    13. Known positive test for human immunodeficiency virus or any other immunosuppressive disease
    14. Known latent or active tuberculosis (TB) at the Screening visit
    15. History (within 2 years prior to the Screening Visit) or evidence/indication of current drug and/or alcohol abuse or dependence, according to the judgment of the Investigator
    16. Previous exposure to fumarate-based drug or a biologic systemic treatment (e.g. tumour necrosis factor-alpha inhibitors, IL-17 inhibitors, IL-17R inhibitors, IL-12/23 p40 inhibitors, IL-23p19 inhibitors or experimental biological product)
    17. Have had a live vaccination within 4 weeks prior to the Baseline Visit, or intend to have a live vaccination during the course of the study, or have participated in a vaccine clinical study within 12 weeks of the Baseline Visit
    18. Patient who intend to use any concomitant medication not permitted by this study or who have not undergone the required washout period, prior to the Baseline Visit, for a particular prohibited medication:
    a. Topical psoriasis treatment (e.g. topical corticosteroids, vitamin A analogues, vitamin D analogues, coal tar, anthracene derivatives, salicylic acid preparations): 2 weeks
    b. Phototherapy (e.g. UV-B light phototherapy, Psoralen-UVA therapy, tanning salon or home-administered UVB): 4 weeks
    c. Conventional systemic anti-psoriatic drugs (e.g. cyclosporine, methotrexate, apremilast or acitretin) excluding fumarate-based drugs: 4 weeks
    d. Any other immunosuppressive medication (e.g. cytostatics, etc.): 6 months
    19. Concomitant treatment with immunomodulating or systemic corticosteroid.
    20. Participating in a drug investigational trial within the 30 days (or five half-lives, whichever is longer) prior to enrolment.
    21. Concurrent systemic therapy with drugs that may interfere with the study drugs taken within the defined washout period
    22. Previously included in the current study
    23. Patient who is employee or relative of employees at the research site or Almirall
    24. Patient with any other serious or uncontrolled physical or mental dysfunction that, as judged by the Investigator, could place the patient at higher risk derived from his/her participation in the study, could confound the results of the study or is likely to prevent the patient from complying with the requirements of the study or completing the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint (Part 2)
    Proportion of patients who were non-responders to DMF at Week 16 that were treated with Tildrakizumab and achieved a PASI 75 at week 40.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 40
    E.5.2Secondary end point(s)
    Secondary endpoints (Part 1 and Part 2):
    Efficacy endpoints (Part 1)
    - Proportion of patients achieving PASI 50, PASI 75 and PASI 90 responses at Week 8 and Week 16 Visits of the Part 1
    - Proportion of patients achieving absolute PASI scores of ≤5, ≤3 and ≤1 at Week 8 and Week 16 Visits of the Part 1
    - Absolute PASI score and change in the absolute PASI score at Week 8 and Week 16 Visits of the Part 1
    - Absolute BSA score and change from baseline in the absolute BSA score at Week 8 and Week 16 Visits of the Part 1
    - Proportion of patients achieving PGA, ScPGA† and PPPGA‡ scores of 0 or 1 at Week 8 and Week 16 Visits of the Part 1
    - Absolute PGA, ScPGA† and PPPGA‡ scores and change in the absolute PGA, ScPGA† and PPPGA‡ scores at Week 8 and Week 16 Visits of the Part 1
    - Proportion of patients achieving DLQI scores of 0 or 1 at Week 8 and Week 16 Visits of the Part 1
    - Absolute DLQI score and change from baseline in the absolute DLQI score at Week 8 and Week 16 Visits of the Part 1
    - Absolute Skindex-16 score and change from baseline in the absolute Skindex-16 score at Week 8 and Week 16 Visits of the Part 1
    - Absolute pruritus-VAS score and change from baseline in the absolute pruritus-VAS score at Week 8 and Week 16 Visits of the Part 1
    - Absolute MOS score and change from baseline in the absolute MOS score at Week 16 Visit of the Part 1
    Efficacy endpoints (Part 2)
    - Proportion of patients achieving PASI 50, PASI 75, PASI 90, and PASI 100 responses at each visit of the Part 2.
    - Proportion of patients achieving absolute PASI scores of ≤5, ≤3 and ≤1 at each visit of the Part 2
    - Absolute PASI score and absolute and percentage change from baseline in the absolute PASI score at each visit of the Part 2
    - Absolute BSA score and change from baseline in the absolute BSA score at each visit of the Part 2
    - Proportion of patients achieving PGA, ScPGA† and PPPGA‡ scores of 0 or 1 at each visit of the Part 2
    - Absolute PGA, ScPGA† and PPPGA‡ scores and absolute and percentage change from baseline in the absolute PGA, ScPGA† and PPPGA‡ scores at each visit of the Part 2Proportion of patients achieving DLQI score of 0 or 1 at Week 32 and Week 40 Visits of the Part 2
    - Absolute DLQI score and absolute and percentage change from baseline in the absolute DLQI score at Week 32 and Week 40 Visits of the Part 2
    - Absolute Skindex-16 score and absolute and percentage change from baseline in the absolute Skindex-16 score at Week 32 and Week 40 Visits of the Part 2
    - Absolute pruritus-VAS score and absolute and percentage change from baseline in the absolute pruritus-VAS score at each visit of the Part 2
    - Absolute MOS score and absolute and percentage change from baseline in the absolute MOS score at Week 40 Visit of the Part 2
    † Only in patients with scalp involvement
    ‡ Only in patients with palmar or plantar involvement
    E.5.2.1Timepoint(s) of evaluation of this end point
    please see section E.5.2
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    DMF
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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.1.1.1In 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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 Decision2019-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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