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    The EU Clinical Trials Register currently displays   43844   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2019-000884-26
    Sponsor's Protocol Code Number:TP0003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-17
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-000884-26
    A.3Full title of the trial
    A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants with Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
    Studio multicentrico di fase 3, randomizzato, in doppio cieco, controllato verso placebo per valutare l’efficacia, la sicurezza e la tollerabilità di rozanolixizumab in soggetti adulti con trombocitopenia immune primaria (ITP) persistente o cronica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP)
    Studio per valutare l’efficacia, la sicurezza e la tollerabilità di rozanolixizumab in soggetti adulti con ITP.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberTP0003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04200456
    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 SponsorUCB Biopharma SRL
    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 supportUCB Biopharma SRL
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB Biosciences GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Str. 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/18/2131
    D.3 Description of the IMP
    D.3.1Product nameRozanolixizumab
    D.3.2Product code [UCB7665]
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.4EV Substance CodeSUB187374
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Immune Thrombocytopenia
    Trombocitopenia immune primaria
    E.1.1.1Medical condition in easily understood language
    Primary immune thrombocytopenia is a autoimmune disease which is characterized by an isolated low platelet count (thrombocytopenia) and the absence of other causes of thrombocytopenia.
    La trombocitopenia immune primaria è una malattia autoimmune che è caratterzzata da un'isolata bassa conta piastrinica (trombocitopenia) e dall'assenza di altre cause di trombocitopenia.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10043554
    E.1.2Term Thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment in study participants with primary immune thrombocytopenia (ITP).
    Dimostrare l’efficacia clinica di rozanolixizumab in trattamento di mantenimento nei partecipanti allo studio con trombovitopenia immune (ITP) primaria.
    E.2.2Secondary objectives of the trial
    Assess the safety and tolerability of rozanolixizumab.
    Valutare la sicurezza e la tollerabilità di rozanolixizumab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Study participants who have consented can participate in the pharmacogenomics sub-study.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: I partecipanti allo studio che hanno dato il loro consenso possono partecipare in un sotto-studio di farmacogenomica.
    E.3Principal inclusion criteria
    - Study participant must be >or= 18 years of age at the time of the Screening Visit;
    - Study participant has a diagnosis of persistent (>3 months duration) or chronic (>12 months duration) primary immune thrombocytopenia (ITP)at the Screening Visit;
    - Study participant has documented intolerance or insufficient response to one or more appropriate courses of standard of care ITP medication prior to Screening;
    - Study participants must have prior history of a response to a previous ITP therapy;
    - If taking allowed immunosuppressive drugs, study participant must be on stable doses during defined time periods prior to Baseline (Day 1);
    - Study participant has a documented history of low platelet count (<30x10^9/L) prior to Screening;
    - Study participant has a platelet count measurement at Screening and atBaseline (Day 1) with an average of the two <30x10^9/L and no single count may be >35x10^9/L (using local laboratories);
    - Study participant has a current or history of a peripheral blood smear consistent with ITP;
    - Study participants may be male or female:
    a. A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
    b. A female participant is eligible to participate if she is not pregnant as confirmed by a negative serum pregnancy test or not planning to get pregnant during the participation in the study, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the dose of study treatment.
    - Il partecipante allo studio deve avere un'età >o= 18 anni al momento della visita di screening;
    - Il partecipante allo studio ha una diagnosi di trombocitopenia immunitaria primaria (ITP) persistente (durata >3 mesi) o cronica (durata >12 mesi) alla visita di screening;
    - Il partecipante allo studio ha una documentata intolleranza o risposta insufficiente a una o più vie di terapia ITP standard prima dello screening;
    - I partecipanti allo studio devono avere una precedente storia di risposta a una precedente terapia ITP;
    - Se è consentita l'assunzione di farmaci immunosoppressivi, il partecipante allo studio deve assumerne dosi stabili durante periodi di tempo definiti prima del Baseline (Giorno 1);
    - Il partecipante allo studio ha una storia documentata di un basso numero di piastrine (<30x10^9/L) prima dello Screening;
    - Il partecipante allo studio ha una misurazione della conta delle piastrine allo Screening e al Basale (Giorno 1) con una media dei due <30x10^9/L e nessun singolo conteggio può essere >35x10^9/L (utilizzando laboratori locali);
    - Il partecipante allo studio ha un'attuale o una storia di uno striscio di sangue periferico coerente con l'ITP;
    - I partecipanti allo studio possono essere uomini o donne:
    a. Il partecipante di sesso maschile deve accettare di usare la contraccezione durante il periodo di trattamento e per almeno 3 mesi dopo la dose finale del trattamento di studio e di astenersi dal donare sperma durante questo periodo
    b. La partecipante di sesso femminile ha diritto a partecipare se non è incinta come confermato da un test di gravidanza sierico negativo o se non prevede di rimanere incinta durante la partecipazione allo studio, non allatta al seno, e se segue almeno una delle seguenti condizioni: non è una donna con potenziale di gravidanza (WOCBP) O una WOCBP che accetti di seguire le linee guida contraccettive durante il periodo di trattamento e per almeno 3 mesi dopo la dose di trattamento in studio.
    E.4Principal exclusion criteria
    - Participant has a history of arterial or venous thromboembolism (eg, stroke, transient ischemic attach, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the 6 months prior to randomization or requires anticoagulant treatment;
    - Study participant has clinically significant bleeding that warrants immediate platelet adjustment (eg, menorrhagia with significant drop in hemoglobin);
    - Study participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs (and/or an investigational device) as stated in this protocol;
    - Study participant has evidence of a secondary cause of immune thrombocytopenia from the past medical history (eg, bacterial or viral infection, past medical history of leukemia, lymphoma, common variable immunodeficiency, systemic lupus erythematosus, autoimmune thyroid disease) or to drug treatments (eg, heparin, quinine, antimicrobials,anticonvulsants) or participant has a multiple immune cytopenia, eg,Evan's syndrome;
    - Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the dose of IMP;
    - Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI);
    - Study participant has a history of a major organ transplant or hematopoietic stem cell/marrow transplant;
    - Study participant has experienced intracranial bleed in the last 6 months prior to the Screening Visit;
    - Study participant has a history of coagulopathy disorders other than ITP;
    - Study participant has a Karnofsky Performance Status rating <60% at the Screening Visit;
    - Study participant with current or medical history of immunoglobulin A (IgA) deficiency, or a measurement of IgA <50 mg/dL at the Screening Visit;
    - Study participant has undergone a splenectomy in the 2 years prior to the Baseline Visit.
    - Il partecipante ha una storia di tromboembolia arteriosa o venosa (ad esempio, ictus, attacco ischemico transitorio, infarto del miocardio, trombosi venosa profonda o embolia polmonare) nei 6 mesi precedenti la randomizzazione o richiede un trattamento anticoagulante;
    - Il partecipante allo studio ha un'emorragia clinicamente significativa che giustifica un immediato aggiustamento delle piastrine (ad esempio, menorragia con un significativo calo dell'emoglobina);
    - Il partecipante allo studio presenta un'ipersensibilità nota a qualsiasi componente del medicinale in fase di sperimentazione (MPI) o a qualsiasi farmaco di confronto (e/o a un dispositivo in fase di sperimentazione), come indicato nel presente protocollo;
    - Il partecipante allo studio ha evidenza di una causa secondaria di trombocitopenia immunitaria dalla storia medica passata (per esempio, infezione batterica o virale, storia medica passata di leucemia, linfoma, immunodeficienza variabile comune, lupus eritematoso sistemico, malattia autoimmune della tiroide) o a trattamenti farmacologici (per esempio, eparina, chinino, antimicrobici, anticonvulsivanti) o il partecipante ha una citopenia immunitaria multipla, per esempio, la sindrome di Evan;
    - Il partecipante allo studio ha un'infezione attiva clinicamente rilevante (ad esempio, sepsi, polmonite o ascesso) a giudizio dello sperimentatore, o ha avuto una grave infezione (che ha portato al ricovero ospedaliero o che richiede un trattamento antibiotico parenterale) entro 6 settimane prima della dose del medicinale in fase di sperimentazione;
    - Partecipante allo studio con una nota infezione da tubercolosi (TBC), ad alto rischio di contrarre un'infezione da TBC, o un'infezione da tubercolosi latente (LTBI), o corrente/storia di infezione micobatterica non tubercolosa (NTMBI);
    - Il partecipante allo studio ha una storia di un importante trapianto di organi o di cellule staminali ematopoietiche/trapianto di midollo;
    - Il partecipante allo studio ha avuto un'emorragia intracranica negli ultimi 6 mesi prima della visita di screening;
    - Il partecipante allo studio ha una storia di disturbi della coagulopatia diversi dall'ITP;
    - Il partecipante allo studio ha una valutazione del Performance Status Karnofsky <60% alla Visita di Screening;
    - Il partecipante allo studio con una storia medica o attuale di deficit di immunoglobulina A (IgA) o una misurazione di IgA <50 mg/dL alla visita di screening;
    - Il partecipante allo studio è stato sottoposto a splenectomia nei 2 anni precedenti la visita di base.
    E.5 End points
    E.5.1Primary end point(s)
    Durable Clinically Meaningful Platelet Response of >o= 50x10^9/L during the last 12 weeks.
    Risposta piastrinica duratura clinicamente significativa >o= 50x10^9/L durante le ultime 12 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the last 12 weeks (Week 13 to Week 25).
    Durante le ultime 12 settimane (dalla settimana 13 alla settimana 25).
    E.5.2Secondary end point(s)
    1. Cumulative number of visits with Clinically Meaningful Platelet Response of >o= 50x10^9/L;
    2. Response defined as platelet count >o=30x10^9/L and at least a 2-fold increase of the Baseline count confirmed on at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding by visit;
    3. Complete Response defined as platelet count >o= 100x10^9/L confirmedon at least 2 separate occasions at two adjacent nominal visits at least 7 days apart, and absence of bleeding by visit;
    4. Time to Clinically Meaningful Platelet Response of >o= 50x10^9/L: time from starting treatment to achievement of first response of >o= 50x10^9/L;
    5. Clinically Meaningful Platelet Response of >o= 50x10^9/L by Day 8;
    6. Time to first rescue therapy;
    7. Response defined as change from Baseline at or above the defined threshold for ITP Patient Assessment Questionnaire (ITPPAQ) SymptomsScore;
    8. Occurrence of treatment-emergent adverse events (TEAEs);
    9. Occurrence of TEAEs leading to withdrawal of investigational medicinal product (IMP).
    1. Numero cumulativo di visite con risposta piastrinica clinicamente significativa >o= 50x10^9/l
    2. Risposta definita come conta piastrinica >o= 30x10^9/l e almeno raddoppiata rispetto al Basale confermata in almeno 2 occasioni separate in due visite nominali adiacenti a distanza di almeno 7 giorni e assenza di sanguinamento in ciascuna visita;
    3. Risposta completa definita come conta piastrinica >o= 100x10^9/l confermata in almeno 2 occasioni separate in due visite nominali adiacenti ad almeno 7 giorni di distanza e assenza di sanguinamento in ciascuna visita;
    4. Tempo alla risposta piastrinica clinicamente significativa >o= 50x10^9/l: tempo dall’inizio del trattamento al raggiungimento della prima risposta >o= 50x109/l;
    5. Risposta piastrinica clinicamente significativa >o= 50x10^9/L entro il giorno 8;
    6. Tempo alla prima somministrazione della terapia di emergenza;
    7. Risposta definita come variazione dal Basale a un livello pari o superiore alla soglia definita per il punteggio relativo ai sintomi del questionario ITP-PAQ (ITP Patient Assessment Questionnaire);
    8. Manifestarsi di eventi avversi durante il trattamento (TEAE);
    9. Manifestarsi di TEAE che portano all’interruzione del medicinale sperimentale (IMP).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.; 2.; 3. and 7. From Baseline during Treatment Period (up to Week 25)
    4. Time from starting treatment to achievement of first response of >o= 50x10^9/L (up to Week 25)
    5. Baseline to Day 8;
    6. From Baseline to first rescue therapy (up to Week 25);
    8. and 9. From Baseline to end of Safety Follow-Up Period (up to Week 31).
    1.; 2.; 3. e 7. dal basale durante il periodo di trattamento (fino alla settimana 25)
    4. Tempo dall'inizio del trattamento al raggiungimento della prima risposta di >o= 50x10^9/l (fino alla settimana 25)
    5. Basale al giorno 8;
    6. Dal basale fino alla prima terapia di emergenza (fino alla settimana 25);
    8. e 9. Dal basale alla fine del periodo di Follow-Up di sicurezza (fino alla settimana 31).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Immunogenicity
    Tollerabilità, immunogenicità
    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. 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Hong Kong
    Moldova, Republic of
    Russian Federation
    United States
    United Kingdom
    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
    last visit of the last subject (LVLS)
    last visit of the last subject (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 months1
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days8
    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: 69
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 105
    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)
    Eligible study participants will be given the opportunity to enroll into the open-label extension (OLE) study, TP0004.
    Ai partecipanti allo studio ritenuti idonei verrà data la possibilità di essere coinvolti in uno studio di estensione in aperto (OLE), TP0004.
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-04-27
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