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    Summary
    EudraCT Number:2020-001690-72
    Sponsor's Protocol Code Number:M20-186
    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:2021-05-24
    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 number2020-001690-72
    A.3Full title of the trial
    A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)
    Studio clinico di Fase 2 di Estensione a Lungo Termine (LTE) con Elsubrutinib e Upadacitinib somministrati da soli oppure in combinazione (ABBV-599) in soggetti affetti da Lupus Eritematoso Sistemico in fase attiva e di grado da moderato a grave che hanno completato lo studio clinico randomizzato e controllato (RCT) di Fase 2 M19-130
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Long-Term Safety and Efficacy of ABBV-599 (ABBV-105 and ABT-494 Given Alone or in Combination) in Participants with Moderately to Severely Active Systemic Lupus Erythematosus who have completed Study M19-130.
    Studio clinico per studiare la sicurezza e l’efficacia a lungo termine di ABBV-599 (ABBV-105 e ABT-494 somministrati da soli oppure in combinazione) in partecipanti affetti da lupus eritematoso sistemico in fase attiva di grado da moderato a grave che hanno completato lo studio clinico M19-130
    A.3.2Name or abbreviated title of the trial where available
    A Phase 2, Long-Term Extension (LTE) Study in Subjects with Moderately to Severely Active SLE
    Uno studio di fase 2, estensione a lungo termine (LTE) in soggetti con LES da moderato a gravemente
    A.4.1Sponsor's protocol code numberM20-186
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU clinical trials helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwell Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441628561090
    B.5.5Fax number441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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 nameElsubrutinib
    D.3.2Product code [ABBV-105]
    D.3.4Pharmaceutical form Capsule
    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 INNElsubrutinib
    D.3.9.1CAS number 1643570-24-4
    D.3.9.2Current sponsor codeABBV-105
    D.3.9.4EV Substance CodeSUB192702
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 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 nameUpadacitinib
    D.3.2Product code [ABT-494]
    D.3.4Pharmaceutical form Film-coated 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 INNUPADACITINIB
    D.3.9.1CAS number 2050057-56-0
    D.3.9.2Current sponsor codeABT-494
    D.3.9.4EV Substance CodeSUB187251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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 nameUpadacitinib
    D.3.2Product code [ABT-494]
    D.3.4Pharmaceutical form Film-coated 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 INNUPADACITINIB
    D.3.9.1CAS number 2050057-56-0
    D.3.9.2Current sponsor codeABT-494
    D.3.9.4EV Substance CodeSUB187251
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number29
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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.1.1.1.IT - Condizione clinica in un linguaggio facilmente comprensibile
    Il lupus eritematoso sistemico (LES) è una patologia cronica in cui il sistema immunitario dell’organismo può attaccare la pelle, le articolazioni, i reni, il cervello e/o altri organi dell’organismo stesso. Spesso colpisce con maggiore frequenza le donne e le persone di origine africana.
    Lupus eritematoso sistemico (LES)
    E.1.1.1Medical condition in easily understood language
    SLE is a chronic disease where the body's immune system may attack the body's own skin, joints, kidneys, brain, and/or other organs. Women and people of African descent are more often affected.
    [campi non sufficienti - vedere sezione E.1.1.EN]
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

    Valutare la sicurezza e tollerabilità a lungo termine di elsubrutinib e upadacitinib somministrati da soli oppure nella forma della combinazione ABBV-599 (elsubrutinib/upadacitinib) in soggetti affetti da LES che hanno completato lo studio di Fase 2 M19-130
    E.2.2Secondary objectives of the trial
    To obtain longer-term efficacy data beyond Week 48 with the treatments studied in the RCT (monotherapies and combination) to more fully assess the risk/benefit of each treatment over time.
    Ottenere dati di efficacia più a lungo termine oltre la Settimana 48 per i trattamenti studiati nell’ambito dello studio clinico randomizzato controllato (RCT) (monoterapie e terapia combinata) per valutare in maniera più approfondita nel tempo il profilo rischi/benefici di ciascun trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects will have completed Study M19-130 (i.e., the preceding study of elsubrutinib, upadacitinib, and ABBV599 [elsubrutinib/upadacitinib] combination)
    2. Subjects must be on stable background treatment for SLE throughout the study.
    3. Subjects must understand and voluntarily sign and date an IEC/IRB- approved informed consent
    4. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test
    5. Female subjects must be either postmenopausal, OR permanently surgically sterile OR practicing at least one protocol-specified method of birth control
    1. Soggetti che hanno completato lo Studio M19-130 (ovvero lo studio pregresso su elsubrutinib, upadacitinib e la combinazione ABBV-599 [elsubrutinib/upadacitinib]).
    2. I soggetti devono essere in trattamento background per LES a dose stabile per l’intera durata dello studio clinico.
    3. I soggetti devono comprendere e volontariamente firmare e datare un consenso informato approvato dal comitato etico.
    4. Le donne in età fertile devono avere un risultato negativo all’test di gravidanza su urine.
    5. i soggetti di sesso femminile devono essere in menopausa OPPURE sterili in maniera permanente dopo intervento chirurgico OPPURE devono utilizzare almeno un metodo contraccettivo fra quelli specificati dal protocollo.
    E.4Principal exclusion criteria
    1. Subjects may not have any active, chronic, or recurrent viral or bacterial infection.
    2. Must not require vaccination with any live vaccine during study participation.
    3. Must not have a history of any malignancy except for successfully treated Non-Melanoma Skin Cancer (NMSC) or localized carcinoma in-situ (CIS) of the cervix.
    4. Must not be a recipient of an organ transplant.
    5. Women must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for at least 30 days after the last dose of study drug.
    1. I soggetti non devono presentare infezione virale o batterica attiva, cronica o ricorrente.
    2. I soggetti non devono necessitare di vaccinazione con qualsiasi vaccino vivo nel corso della partecipazione allo studio.
    3. I soggetti non devono avere una storia di neoplasia maligna di qualsiasi tipo, ad eccezione del carcinoma cutaneo non melanoma (NMSC) oppure carcinoma localizzato in situ (CIS) della cervice uterina trattati con successo.
    4. I soggetti non devono aver ricevuto un trapianto d’organo.
    5. Le donne non devono essere in stato di gravidanza, non devono allattare al seno o programmare una gravidanza durante lo studio clinico e per almeno 30 giorni dopo l’ultima dose del medicinale sperimentale.
    E.5 End points
    E.5.1Primary end point(s)
    Not applicable.
    Non applicabile
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable.
    Non applicabile
    E.5.2Secondary end point(s)
    • SLE Responder Index (SRI)-4.
    • British Isles Lupus Assessment Group (BILAG)-Based Combined Lupus Assessment (BICLA).
    • Steroid burden, assessed as change from M19-130 Baseline.
    • Number of mild, moderate or severe flares per patient-year (respectively and overall) by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI flare index (SFI), assessed by number and types of flare per subject compared across treatment groups .
    • Punteggio SRI-4 (SLE Responder Index)
    • Punteggio dell’indice BICLA (BILAG [British Isles Lupus Assessment Group] Based Combined Lupus Assessment)
    • Burden del trattamento con steroidi, valutato sulla base della variazione rispetto al baseline dello studio M19-130
    • Numero di esacerbazioni lievi, moderate o gravi per anno-paziente (rispettivamente per ciascuna gravità e globalmente) in base al punteggio dell’indice relativo alle esacerbazioni (SFI) SLEDAI modificato sulla base dello studio SELENA (Safety of Estrogens in Lupus Erythematosus National Assessment), valutato in base al numero e ai tipi di esacerbazione per soggetto, confrontato fra i diversi gruppi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    All visits.
    Tutte le visite
    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 Yes
    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) 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 EEA37
    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
    Australia
    Canada
    China
    Colombia
    Japan
    Korea, Republic of
    Mexico
    Taiwan
    United States
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    Argentina
    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
    The end-of-study is defined as the date of the last subject's last visit, or date of the last follow-up contact, whichever is later.
    Per conclusione dello studio si intende la data dell’ultima visita dell’ultimo soggetto, oppure la data dell’ultimo contatto di follow-up, quale dei due avvenga per ultimo
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Those that cannot consent on their own to the study for certain purposes per local regulations. The legally authorized representative would fulfill all statutory requirements for the patient.
    Quelli che non possono acconsentire da soli allo studio per determinati scopi secondo le norme locali. Il rappresentante legalmente autorizzato soddisferebbe tutti i requisiti di legge per il paziente.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 260
    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)
    AbbVie does not plan to offer any additional therapies after the subject's last study visit or discontinuation of study drug.
    AbbVie non intende offrire ai soggetti alcuna terapia aggiuntiva dopo la loro ultima visita per lo studio o dopo l’interruzione del medicinale sperimentale
    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 Decision2020-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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