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    Summary
    EudraCT Number:2020-003420-16
    Sponsor's Protocol Code Number:SPRINT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003420-16
    A.3Full title of the trial
    SPRINT_”AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS.”
    SPRINT_ "UNO STUDIO IN APERTO, MULTICENTRICO, PER VALUTARE GLI ALGORITMI DI TRATTAMENTO STEP-UP E TOP-DOWN NELLA COLITE ULCEROSA DA MODERATA A GRAVE".
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.
    Uno studio che confronta due diversi approcci terapeutici nel trattamento della colite ulcerosa da moderata a grave
    A.3.2Name or abbreviated title of the trial where available
    SPRINT
    SPRINT
    A.4.1Sponsor's protocol code numberSPRINT
    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 SponsorIRCCS ISTITUTO CLINICO HUMANITAS
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationB-COM
    B.5.2Functional name of contact pointLaetitia Bigot
    B.5.3 Address:
    B.5.3.1Street Address152 rue du Béliot
    B.5.3.2Town/ cityDax
    B.5.3.3Post code40990
    B.5.3.4CountryFrance
    B.5.6E-maillbigot@bcom.eu
    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 Amgevita
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAdalimumab
    D.3.2Product code [n.d.]
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor coden.d.
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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.2.5The 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 nameAzatioprina
    D.3.2Product code [n.d.]
    D.3.4Pharmaceutical form Modified-release 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 INNAZATIOPRINA
    D.3.9.2Current sponsor coden.d.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 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.2.5The 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 namePrednisone
    D.3.2Product code [n.d.]
    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 INNPREDNISONE
    D.3.9.2Current sponsor coden.d.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.2Current sponsor coden.d.
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 ulcerative colitis.
    Colite ulcerosa da moderata a grave.
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis in a moderate or severe form.
    Colite ulcerosa in forma moderata o grave.
    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 10045365
    E.1.2Term Ulcerative colitis
    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
    The primary objective is to assess the efficacy of a top-down approach in achieving histological improvement at week 52, without colectomy and without UC-related hospitalization versus a standard step-up approach.
    L’obiettivo primario è la valutazione dell’efficacia di un approccio top-down nell’ottenere miglioramenti istologici alla settimana 52 senza colectomia e senza ricovero correlato all’UC a confronto con un approccio step-up standard.
    E.2.2Secondary objectives of the trial
    to compare the efficacy of the TD approach to induce histological remission and histological healing in the short-term (week16) vs. the standard SU approach
    to compare the efficacy of the TD approach to induce clinical remission (combined clinical and endoscopic improvement=sub-score of 0 or 1 with rectal bleeding=0 AND Mayo endoscopic sub score=1) in the short- and long-term (weeks16 and 52) vs the standard SU approach
    to compare the efficacy of the TD approach to induce short- and long-term mucosal healing (endoscopic and histologic inprovement defined as a defined as a Mayo endoscopic subscore=0 AND a Nancy score=0) vs the standard SU approach (weeks 16 and 52)
    to compare the safety of the TD approach through week52 vs the standard SU approach
    to compare the quality of life of patients treated with the TD approach through week 52 vs the standard SU approach
    to compare the need for colectomies and UC-related hospitalizations in patients treated with the TD approach vs the SU approach
    confrontare efficacia approccio top-down TD nell’indurre remissione istologica e guarigione istologica nel breve termine (sett16) a confronto con approccio step-up SU standard
    confrontare efficacia appr TD nell’indurre remissione clinica (miglioramento combinato clinico ed endoscopico=subscore di 0 o 1 con sanguinamento rettale=0 E subscore endoscopico Mayo = 1) nel breve e lungo termine (sett16 e 52) a confronto con appr SU standard
    confrontare efficacia appr TD nell’indurre guarigione mucosale (miglioramento endoscopico e istologico definito come un subscore endoscopico Mayo=0 E un punteggio Nancy=0) nel breve e lungo termine a confronto con appr SU standard (sett16 e sett52)
    confrontare sicurezza appr TD fino alla sett52 a confronto con appr SU standard
    confrontare qualità della vita dei pazienti trattati con appr TD fino alla sett52 a confronto con appr SU standard
    confrontare necessità di colectomie e ricoveri correlati a UC in pazienti trattati con appr TD a confronto con appr SU
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients (age = 18 years and < 75 years)
    - Established diagnosis of UC (confirmed clinically, endoscopically and histologically) since at least 3 months
    - Disease duration no longer than 24 months before the screening visit
    - Ongoing oral 5-ASA treatment =1.6g/day
    - Having objective signs of moderate-to-severe UC activity, defined by a total Mayo score of 6 to 12
    - Proctitis, left-sided or extensive UC
    - Ability to perform study requirements
    - Ability to give informed consent according to ICH/ GCP, and national/local
    - Pazienti adulti (età = 18 anni e < 75 anni)
    - Diagnosi certa di UC (confermata clinicamente, endoscopicamente e istologicamente) da almeno tre mesi
    - Durata della malattia non superiore ai 24 mesi prima della visita di screening
    - Trattamento a base di 5-ASA per via orale (= 1.6g/giorno) in corso
    - Presenza di segni obiettivi di attività da moderata a grave della UC, definita da un punteggio Mayo totale tra 6 e 12
    - Proctite, colite ulcerosa sinistra o pancolite
    - Capacità di svolgere i requisiti dello studio
    - Capacità di dare il consenso informato in conformità a ICH/GCP e alla normativa nazionale/locale
    E.4Principal exclusion criteria
    - Have received any kind of treatment approved for UC (thiopurine, biologics, tofacitinib) apart from 5-ASA compounds, sulphasalazine or EcN during their UC history
    - Currently receiving local or systemic steroids (past steroids treatments are accepted)
    - Have concomitant history of segmental colitis associated to diverticula
    - Have active infections during the screening phase (patients can be rescreened after the infection is resolved
    - Have concomitant anti-HBcAb+ and HBsAg- at screening
    - Have a diagnosis of Crohn's disease
    - Have any contra-indication to study drugs or procedures
    - Are pregnant or in active breastfeeding at the time of inclusion.
    - Have planned intestinal surgery at time of randomization
    - Any contra-indication to anti-TNF therapy
    - Hanno ricevuto qualunque tipo di trattamento approvato per la UC (tiopurina, farmaci biologici, tofacitinib) salvo composti 5-ASA, salazosulfapiridina o EcN (Escherichia coli Nissle) nel corso della loro UC
    - Hanno in corso trattamenti con steroidi locali o sistemici (sono accettabili i trattamenti con steroidi già conclusi)
    - Hanno una concomitante storia di colite segmentale associata a diverticolosi
    - Hanno infezioni attive nella fase di screening (i pazienti possono ripetere lo screening una volta risolta l’infezione)
    - Hanno contemporaneamente anti-HBcAb+ e HBsAg- allo screening
    - Hanno una diagnosi di morbo di Crohn
    - Hanno controindicazioni ai farmaci o alle procedure dello studio
    - Sono in gravidanza o in allattamento al momento dell’inclusione
    - Hanno un intervento chirurgico intestinale programmato all’epoca dell’assegnazione casuale
    - Hanno controindicazioni alla terapia anti-TNF
    E.5 End points
    E.5.1Primary end point(s)
    Histological improvement (defined as a Nancy index = 1) at week 52, without colectomy and without UC-related hospitalization.
    Miglioramento istologico (definito come indice di Nancy = 1) alla settimana 52, senza colectomia e senza ricovero per CU.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    Settimana 52
    E.5.2Secondary end point(s)
    - Histological remission (Nancy Index =0) at week 52
    - Histological healing (defined as a Nancy score = 1) at week 16
    - Clinical remission (PRO2 remission + endoscopic remission) at week 52
    - Clinical remission (PRO2+endoscopic remission) at week 16
    - Symptomatic remission (PRO2 remission) at week 16
    - Symptomatic remission (PRO2 remission) at week 52
    - Endoscopic improvement at week 16
    - Endoscopic improvement at week 52
    - Endoscopic remission at week 16
    - Endoscopic remission at week 52
    - Mucosal healing (endoscopic and histologic improvement) at week 16
    - Mucosal healing (endoscopic and histologic improvement) at week 52
    - Changes in fecal calprotectin levels from baseline
    - Need for corticosteroids at weeks 16 and 52
    - To evaluate and compare the safety of the two strategies in terms of adverse events, serious adverse events, and adverse events leading to discontinuation
    - Quality of life (measured by the S-IBDQ and SF-36) at weeks 16 and 52
    - Rates of colectomies at weeks 16, 52, and 104 (or end of study)
    - UC-related hospitalizations at weeks 16, 52, and 104 (or end of study)
    - Remissione istologica (Indice di Nancy = 0) a settimana 52
    - Guarigione istologica (definita come punteggio di Nancy = 1) a settimana 16
    - Remissione clinica (remissione PRO2 + remissione endoscopica) a settimana 52
    - Remissione clinica (PRO2 + remissione endoscopica) a settimana 16
    - Remissione sintomatica (PRO2 remissione) a settimana 16
    - Remissione sintomatica (PRO2 remissione) a settimana 52
    - Miglioramento endoscopico a settimana 16
    - Miglioramento endoscopico a settimana 52
    - Remissione endoscopica a settimana 16
    - Remissione endoscopica a settimana 52
    - Guarigione della mucosa (miglioramento endoscopico e istologico) a settimana 16
    - Guarigione della mucosa (miglioramento endoscopico e istologico) a settimana 52
    - Cambiamenti nei livelli di calprotectina fecale rispetto al basale
    - Necessità di corticosteroidi a settimane 16 e 52
    - Valutare e confrontare la sicurezza delle due strategie in termini di eventi avversi, eventi avversi gravi ed eventi avversi che portano alla sospensione
    - Qualità della vita (misurata da S-IBDQ e SF-36) alle settimane 16 e 52
    - Tassi di colectomie alle settimane 16, 52 e 104 (o alla fine dello studio)
    - Ricoveri per CU alle settimane 16, 52 e 104 (o alla fine dello studio)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 and/or week 52, depending on the endpoints
    Settimana 16 e/o settimana 52, a seconda degli endpoint
    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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Due diversi approcci terapeutici (step-up e top-down) sono confrontati rispetto allo stesso IMP
    Two different therapeutic approaches (step-up and top-down) are compared with the same IMP
    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 EEA75
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    France
    Germany
    Italy
    Portugal
    Spain
    Sweden
    Switzerland
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 350
    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)
    n.a.
    n.a.
    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 Decision2021-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-24
    P. End of Trial
    P.End of Trial StatusOngoing
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