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    Summary
    EudraCT Number:2016-000101-37
    Sponsor's Protocol Code Number:IM128-035
    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:2018-02-27
    Trial results View 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 number2016-000101-37
    A.3Full title of the trial
    A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome
    Studio di fase II randomizzato, multicentrico, in doppio cieco, controllato con placebo, per valutare l’efficacia e la sicurezza di BMS-931699 (lulizumab) o di BMS-986142 in soggetti affetti da sindrome di Sjögren primaria da moderata a grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
    Studio per valutare l'efficacia e la sicurezza di BMS-931699 (Lulizumab) o BMS-986142 nella sindrome di Sjögren primaria
    A.3.2Name or abbreviated title of the trial where available
    POC H2H study
    POC H2H study
    A.4.1Sponsor's protocol code numberIM128-035
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02843659
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1171-5832
    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 SponsorBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
    B.1.3.4CountryBelgium
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032
    B.5.5Fax number0032
    B.5.6E-mailclinical.trials@bms.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 nameBTK Inhibitor
    D.3.2Product code BMS-986142
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBTK Inhibitor
    D.3.9.1CAS number 1643368-58-4
    D.3.9.2Current sponsor codeBMS986142
    D.3.9.3Other descriptive nameBMS986142
    D.3.9.4EV Substance CodeSUB179398
    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: 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 nameBTK Inhibitor
    D.3.2Product code 1643368-58-4
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBTK Inhibitor
    D.3.9.1CAS number 1643368-58-4
    D.3.9.2Current sponsor codeBMS986142
    D.3.9.3Other descriptive nameBMS986142
    D.3.9.4EV Substance CodeSUB179398
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameAnti-CD28dab
    D.3.2Product code BMS-931699
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-CD28dAb
    D.3.9.1CAS number 1421830-13-8
    D.3.9.2Current sponsor codeBMS-931699
    D.3.9.3Other descriptive nameAnti-CD28dAb
    D.3.9.4EV Substance CodeSUB168198
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    subjects with moderate to severe Sjögren's syndrome
    Soggetti affetti da sindrome di Sjögren da moderata a grave
    E.1.1.1Medical condition in easily understood language
    subjects with moderate to severe Sjögren's syndrome
    Soggetti affetti da sindrome di Sjögren da moderata a grave
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040766
    E.1.2Term Sjogren's disease
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10048676
    E.1.2Term Sjogren-Larsson syndrome
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040767
    E.1.2Term Sjogren's syndrome
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042846
    E.1.2Term Syndrome Sjogren's
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10040765
    E.1.2Term Sjogren's
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren’s syndrome as measured by the change from baseline in ESSDAI at Week 12 between active treatment arms (lulizumab or BMS-986142, respectively) and the placebo arm
    Valutare l’efficacia del trattamento con lulizumab o con BMS-986142 rispetto al placebo in soggetti affetti da sindrome di Sjögren primaria da moderata a grave, in base alla variazione del punteggio ESSDAI dal basale alla Settimana 12 tra i bracci in trattamento attivo (lulizumab o BMS-986142, rispettivamente) e il braccio placebo.
    E.2.2Secondary objectives of the trial
    To assess the:-Change from baseline in ESSPRI score at Wk 12 -Proportion of subject from baseline at wk12 with:>3 pt improvement in ESSDAI/>1 pt improvement in ESSPRI/both >3 pt improvement in ESSDAI and >1 pt improvement in ESSPRI -Change from baseline at Wk 4 and Wk 8: in ESSDAI and ESSPRI scores -Change from baseline in ESSPRI components at Wk 4, 8 and 12-Change from baseline in unstimulated and stimulated salivary flow at Wks 4, 8, and 12-Change from baseline in ocular surface staining, Schirmer’s test, and tear-break up time test at Wks 4, 8,and 12-Safety and tolerability of lulizumab or BMS-986142 in subjects with moderate to severe pSS, as measured by adverse events, laboratory parameters, vital signs, physical exams, and ECGs-Change from baseline in patient and physician assessments of disease activity:NRS scores for mouth, eye and vaginal dryness/patGDA and phyGDA/PROMIS Fatigue SF/SF-36 acute/FSFI/WPAI-Trough plasma concentrations of lulizumab and BMS-986142 in pSS subjects
    Valutare i seguenti parametri:
    • Variazione dal basale del punteggio dell’indice riferito dal paziente con sindrome Sjögren della Lega europea contro le malattie reumatiche (EULAR’s Sjögren’s Syndrome Patient-Reported Index, ESSPRI) alla Settimana 12
    • Proporzione di soggetti con un miglioramento di  3 punti rispetto al basale del punteggio ESSDAI alla Settimana 12
    • Proporzione di soggetti con un miglioramento di  1 punto dal basale del punteggio ESSPRI alla Settimana 12
    • Proporzione di soggetti con un miglioramento sia di  3 punti del punteggio ESSDAI sia di ≥ 1 punto del punteggio ESSPRI dal basale alla Settimana 12
    • Variazione rispetto al basale dei punteggi ESSDAI alla Settimana 4 e alla Settimana 8
    • Variazione rispetto al basale dei punteggi ESSPRI alla Settimana 4 e alla Settimana 8
    • Variazione rispetto al basale delle componenti dell’indice ESSPRI (secchezza, affaticamento e dolore) alle Settimane 4, 8 e 12
    ecc
    PER LA LISTA COMPLETA, FAR RIF. AL PROTOCOLLO DI STUDIO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-70 years old
    - Subjects diagnosed or classified as having moderate to severe primary Sjögren’s syndrome based on the 2015 ACR-EULAR Classification Criteria
    - ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
    - Positive anti-SS-A/Ro or anti-SS-B/La autoantibody
    - Unstimulated whole saliva secretion > 0.01 ml/min
    - Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted.
    • Età compresa tra 18-70 anni;
    • Soggetti che hanno ricevuto una diagnosi di, o sono stati classificati come affetti da, sindrome di Sjögren da moderata a grave in base ai criteri di classificazione per la sindrome di Sjögren ACR-EULAR del 2015, con una durata della malattia dalla diagnosi che deve essere, alla visita di screening, di almeno 16 settimane, ma non superiore a 7 anni
    • Punteggio ESSDAI  5; inclusa attività della malattia (qualsiasi punteggio > 0) in almeno uno dei seguenti domini: ghiandolare, articolare, ematologico, biologico, linfoadenopatia
    • Positività agli autoanticorpi anti-SS-A/Ro o anti-SS-B/La
    • Secrezione salivare non stimolata > 0,01 ml/min
    • Donne in età fertile (donne potenzialmente fertili) devono avere una negatività del siero o
    del test di gravidanza (sensibilità minima di 25 IU/L o unità
    equivalenti di HCG) nelle 24 ore prima dell'inizio del farmaco in studio e non devono essere
    gravide o in l'allattamento. Soggetti maschi e femmine devono essere disposti ad adottare metodi contraccettivi altamente efficaci come descritti nel protocollo di studio per tutta la
    durata dello studio e per il periodo di follow-up specificato nel protocollo.
    Non sono consentiti metodi contraccettivi a base di ormoni.
    E.4Principal exclusion criteria
    -Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis)
    -Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
    -Active systemic bacterial (including tuberculosis), viral or fungal infection, or evidence of prior or current Hepatitis B or C, HIV infection, latent bacterial, viral or fungal infections
    -Any significant concurrent medical condition at the time of screening or baseline visit
    -Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
    -Previous treatment with other biologics either marketed or in development within 6 months prior to screening visit
    -Treatment started or an unstable dose of hydroxychloroquine within
    8 weeks of screening visit.
    -Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit.
    - Sindrome di Sjögren secondaria o presenza di qualsiasi altra malattia sistemica
    autoimmune (es, RA, LES, sclerosi multipla)
    - Sindrome di Sjogren primaria molto grave o con gravi complicazioni, al momento della visita di screening.
    - Infezione sistemica batterica (compresa la tubercolosi) virale o fungina attiva o evidenza di una precedente epatite B o C, infezione da HIV, infezioni latenti batteriche, virali o fungine;
    - qualsiasi condizione medica concomitante significativa al momento dello screening o della
    visita basale;
    - Uso di metotrexato, ciclofosfamide, ciclosporina, tacrolimus, azatioprina, micofenolato mofetile (MMF) o leflunomide entro 12 settimane dalla visita di screening;
    - Precedente trattamento con altri farmaci biologici sia in commercio o in sviluppo nei 6 mesi precedenti la visita di screening;
    -Iniziare un trattamento o avere una dose instabile di idrossiclorochina entro le 8 settimane dalla visita di screening.
    - Corticosteroidi orali > 10 mg /die entro 14 giorni dal giorno 1 di somministrazione dei farmaci in studio, terapia con corticosteroidi ≥ 1 mg / kg durante le 4 settimane precedenti l’arruolamento, corticosteroidi per via endovenosa, intramuscolare o intra-articolare entro 4 settimane dalla visita di screening.
    E.5 End points
    E.5.1Primary end point(s)
    To compare the change from baseline in ESSDAI score at Week 12
    between active treatment arms (lulizumab or BMS-986142) and the
    placebo arm
    L’endpoint primario consiste nel confrontare la variazione del punteggio ESSDAI dal basale alla Settimana 12 tra i bracci in trattamento attivo (lulizumab o BMS-986142) e il braccio placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    settimana 12
    E.5.2Secondary end point(s)
    (1)Change from baseline in ESSPRI score
    (1)Proportions of subjects with >3 points of improvement from baseline in ESSDAI
    (1)Proportions of subjects with >1 point of improvement from baseline in ESSPRI
    (1)Proportion of subjects with both >3 points improvement in ESSDAI and >1 point improvement in ESSPRI from baseline
    (2)Change from baseline in ESSDAI score
    (2)Change from baseline in ESSPRI score
    (3)Change from baseline in ESSPRI individual component (Dryness, Fatigue, and Pain) scores
    (3)Change from baseline in unstimulated and stimulated salivary flow
    (3)Change from baseline in ocular surface staining, Schrimer's test, and the tear break-up time test
    (4)Safety and tolerability of lulizumab or BMS-986142 in subjects with moderate to severe pSS
    (4)Numeric rating scale (NRS) for mouth, eye and vaginal dryness
    (4)Patient and physician Global Assessment of Disease activity
    (4)Short Form-36 acute (SF-36 acute)
    (4)Female Sexual Function Index (FSFI)
    (4)Work Participation and Activity Impairment Questionnaire (WPAI)
    (4)PROMIS Fatigue Short Form
    (4)Trough plasma concentrations of lulizumab and BMS-986142 in pSS subjects
    (1) Variazione dal basale del punteggio ESSPRI alla Settimana 12
    (1) Proporzione di soggetti con un miglioramento di ≥ 3 punti del punteggio ESSDAI dal basale alla Settimana 12
    (1) Proporzione di soggetti con un miglioramento di ≥ 1 punti del punteggio ESSPRI dal basale alla Settimana 12
    (1) Proporzione di soggetti con un miglioramento sia di ≥ 3 punti nel punteggio ESSDAI sia di ≥ 1 punto nel punteggio ESSPRI dal basale alla Settimana 12
    • Variazione rispetto al basale dei seguenti parametri:
    o (2) Punteggi ESSDAI alla Settimana 4 e alla Settimana 8
    o (2) Punteggi ESSPRI alla Settimana 4 e alla Settimana 8
    o (3)Punteggi delle singole componenti dell’indice ESSPRI (secchezza, affaticamento e dolore) alle Settimane 4, 8 e 12
    o (3) Tasso di flusso salivare non stimolato e stimolato alle Settimane 4, 8 e 12
    o (3)Colorazione della superficie oculare, test di Schirmer e tempo di rottura del film lacrimale alle Settimane 4, 8 e 12
    (4) Sicurezza e tollerabilità di lulizumab o BMS-986142 misurate in base ad eventi avversi, parametri di laboratorio, parametri vitali, esami obiettivi ed ECG
    (4) Variazione rispetto al basale delle valutazioni di paziente e medico dell’attività della malattia:
    o Scala numerica (NRS) relativa alla secchezza orale, oculare e vaginale
    o Valutazione globale del soggetto dell’attività della malattia (SubGDA) e valutazione globale del medico dell’attività della malattia (phyGDA)
    o Questionario Short Form-36 (SF-36)
    o Indice di funzionalità sessuale femminile (FSFI)
    o Questionario sull’attività lavorativa e la compromissione dell’attività (WPAI)
    o Modulo breve PROMIS
    (4) Concentrazioni minime di BMS-931699 e BMS-986142 nei punti di rilevazione specificati dal protocollo
    E.5.2.1Timepoint(s) of evaluation of this end point
    (1)Week 12
    (2)Up to Week 8
    (3)Up to Week 12
    (4)Up to Week 18
    (1) Settimana 12
    (2) Fino alla settimana 8
    (3 Fino alla settimana 12
    (4) Fino alla settimana 18
    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 No
    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) 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Belgium
    Chile
    Colombia
    Denmark
    France
    Greece
    Italy
    Mexico
    Netherlands
    Norway
    Peru
    Poland
    Romania
    Russian Federation
    South Africa
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 120
    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)
    At the end of the study, BMS will not continue to provide BMS supplied study drug to subjects/investigators unless BMS chooses to extend the study. Please refer to section 3.2 of the protocol
    Al termine dello studio, BMS non continuerà a fornire i farmaci in studio a meno che non decida, a sua discrezione, di estendere lo studio . Si prega di fare riferimento alla sezione 3.2 del protocollo.  
    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 Decision2017-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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