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    Summary
    EudraCT Number:2016-002126-36
    Sponsor's Protocol Code Number:BP39261
    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:2018-01-31
    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 number2016-002126-36
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RO7123520 AS ADJUNCT TREATMENT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO TNF-α INHIBITORS
    STUDIO MULTICENTRICO DI FASE II, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, ATTO A VALUTARE LA SICUREZZA E L’EFFICACIA DI RO7123520 COME TRATTAMENTO ADIUVANTE IN PAZIENTI AFFETTI DA ARTRITE REUMATOIDE ATTIVA DA MODERATA A GRAVE E RISPOSTA INADEGUATA AGLI INIBITORI DEL TNF-α
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and efficacy of RO7123520 as adjunct treatment in patients with moderately to severely active rheumatoid arthritis and an inadequate response to TNF-a inhibitors
    Uno studio atto a valutare la sicurezza e l'efficacia di RO7123520 come trattamento adiuvante in pazienti affetti da Artrite reumatoide attiva da moderata a grave e risposta inadeguata agli inibitori del TNF-a
    A.4.1Sponsor's protocol code numberBP39261
    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 SponsorF. Hoffmann - Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann - La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann - La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentech@roche.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 nameRO7123520
    D.3.2Product code RO7123520/F03-01
    D.3.4Pharmaceutical form Concentrate for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid Arthritis
    Artrite reumatoide
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis is a form of arthritis that causes pain, swelling, stiffness and loss of function in the joints
    L'artrite reumatoide è una forma di artrite che provoca dolore, gonfiore, rigidità e perdita delle articolazioni
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety, tolerability and efficacy of RO7123520 as adjunctive treatment with MTX and anti-TNF-α therapy in patients with moderately to severely active RA with an anti-TNF-α inadequate response (Study Parts 1,2,3).
    Valutare sicurezza, tollerabilità ed efficacia di RO7123520 come trattamento adiuvante con metotrexato (MTX) e terapia anti-TNF-α nei pazienti con artrite reumatoide (AR) attiva da moderata a grave con risposta inadeguata agli inibitori del TNF-α (Parti 1, 2 e 3 dello studio).
    E.2.2Secondary objectives of the trial
    • To assess the dose-ranging efficacy of RO7123520 (Study Part 3).
    • To assess the exposure versus response relationship and immunogenicity of RO7123520 (Study Parts 1,2,3).
    • Valutare l’efficacia di RO7123520 a dose variabile (Parte 3 dello studio).
    • Valutare il rapporto tra esposizione rispetto alla risposta e l’immunogenicità di RO7123520 (Parti 1, 2 e 3 dello studio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult men and women, 18 to 80 years of age (inclusive).
    4. Diagnosis of adult-onset RA as defined by the American College of Rheumatology (ACR) 2010 criteria, for at least 6 months before screening.
    5. Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints (Note: surgically treated joints cannot be counted in TJC/SJC for enrollment purposes).
    6. For Part 2 only: Active synovitis and/or osteitis of the dominant hand/wrist as determined by contrast-enhanced MRI.
    7. Patients must be taking one of the following anti-TNF-α therapies: certolizumab, golimumab, etanercept, adalimumab or approved biosimilars of these, given at an approved and stable dose for at least 12 weeks before randomization and have experienced in the opinion of the Investigator an inadequate response to anti-TNF-α therapy with a DAS28≥ 3.2. Note: prior use of other anti-TNF-α therapies is allowed.
    8. Patients must be taking MTX (PO, SC, or IM) for at least 12 weeks before randomization and must be on a stable dose for at least 4 weeks before randomization (7.5 to 25 mg/week). Note: The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety or intolerability reasons. Local standard-of-care should be followed for concomitant administration of folic acid.
    9. Patients on glucocorticoids (≤ 10 mg/day PO prednisone or equivalent) are permitted if doses are stable within 6 weeks of planned randomization. Note: Patients should remain on stable doses of glucocorticoids throughout the duration of study unless for safety or intolerability reasons.
    10. Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (e.g., up to 2-3 times weekly) for short-term relief of pain are allowed, and patients on regular NSAID use (i.e., on stable dose for ≥ 4 weeks) are allowed. Note: NSAIDs must not be taken for at least 2 days before clinical assessments in the study for patients with intermittent use of NSAIDs. If needed for symptomatic relief, paracetamol (up to 3 g/day) is permitted.
    11. Negative pregnancy test at screening and baseline (women only), and agreement to comply with measures to prevent pregnancy and restrictions on sperm donation
    Uomini e donne adulti di età compresa tra 18 e 80 anni (inclusi).
    3. Diagnosi di AR con insorgenza in età adulta, in base alla definizione sancita dai criteri dell’American College of Rheumatology (ACR) 2010, per almeno 6 mesi prima dello screening.
    4. AR attiva da moderata a grave, definita come almeno 4/28 articolazioni dolenti (TJC) e almeno 4/28 articolazioni tumefatte (SJC) (nota: le articolazioni trattate con intervento chirurgico non possono essere contate come TJC/SJC ai fini dell’arruolamento).
    5. Solo per la Parte 2: sinovite acuta e/od osteite della mano/polso dominante rilevate con RM con mezzo di contrasto.
    6. I pazienti devono assumere una delle seguenti terapie anti-TNF-α: certolizumab, golimumab, etanercept, adalimumab o i relativi biosimilari approvati, somministrati ad una dose approvata e stabile per almeno 12 settimane prima della randomizzazione e manifestare, a giudizio dello sperimentatore, una risposta inadeguata alla terapia anti-TNF-α con DAS28 ≥3,2. Nota: è consentito il previo uso di altre terapie anti-TNF-α.
    7. I pazienti devono assumere MTX (PO, SC oppure IM) da almeno 12 settimane prima della randomizzazione e devono ricevere una dose stabile per almeno 4 settimane prima della randomizzazione (da 7,5 a 25 mg/settimana). Nota: si prevede che la dose di MTX rimanga stabile per tutta la durata dello studio e possa essere aggiustata solo per motivi di sicurezza o intollerabilità. Lo standard di cura locale dovrà essere seguito per la somministrazione concomitante di acido folico.
    8. I pazienti sottoposti a glucocorticoidi (≤10 mg/die PO di prednisone o equivalente) sono ammessi se le dosi sono stabili nelle 6 settimane precedenti alla randomizzazione programmata. Nota: i pazienti devono continuare ad assumere dosi stabili di glucocorticoidi per tutta la durata dello studio, fatta eccezione per motivi di sicurezza o intollerabilità.
    9. Sono ammessi i pazienti che assumono farmaci antinfiammatori non steroidei (FANS) in modo intermittente (ad esempio fino a 2-3 volte alla settimana) per alleviare temporaneamente il dolore, e i pazienti che usano regolarmente i FANS (ad esempio a dose stabile per  4 settimane). Nota: i FANS non devono essere assunti dai pazienti che usano i FANS in modo intermittente per almeno 2 giorni prima delle valutazioni cliniche dello studio e non devono essere assunti regolarmente (>2-3 volte/settimana) durante lo studio. Se necessario per un sollievo sintomatico, è consentito il paracetamolo (fino a 3 g/die).
    10. Test di gravidanza negativo allo screening e al basale (solo le donne) e consenso a rispettare le misure di prevenzione della gravidanza e le restrizioni sulla donazione dello sperma,
    E.4Principal exclusion criteria
    1. Currently receiving concomitant treatment with sulfasalazine or leflunomide. Note: Enrollment is allowed after an appropriate wash-out period (i.e., 5 half-lives).
    12. Patients currently on IV infliximab or an approved IV biosimilar of it are excluded.
    13. Parenteral glucocorticoids administration (IM, IV) of ≥50 mg within 6 weeks or ≤50 mg within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study.
    14. Joint(s) injected with intra-articular glucocorticoids within 6 weeks prior to planned randomization.
    15. Active inflammatory diseases of the joints not related to RA: Gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease.
    16. Systemic autoimmune disease other than RA: Systemic lupus erythematosus, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed forms of connective tissue inflammatory diseases.
    17. Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16.
    18. Active fibromyalgia that makes appropriate RA disease activity challenging for the Investigator.
    19. RA patients functional status class IV according to the ACR 1991 criteria (i.e., largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to wheelchair).
    20. Patients with severe chronic or recurrent viral, bacterial, parasitic or fungal infections.
    21. History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection.
    22. Any identified confirmed congenital or acquired immunodeficiency.
    23. Abnormal laboratory values:
    • Hemoglobin level is less than 80 g/L.
    • Leucocyte level is less than 2.5 × 109/L.
    • Absolute neutrophil count is less than 1.0 × 109/L.
    • Thrombocyte level is less than 75 × 109/L.
    24. Laboratory test results for liver function meeting criteria for marked abnormality (ULN: upper limit of normal): Alkaline phosphatase: > 3 × ULN; aspartate aminotransferase: > 3 × ULN; alanine aminotransferase: > 3 × ULN; γ-glutamyl transferase: > 3 × ULN.
    25. Other unstable somatic diseases apart from RA that can increase the probability of adverse events during the study, mask, enhance or alter the symptoms of RA or cause clinical or laboratory symptoms similar to that of RA.
    26. Major surgery within 28 days prior to randomization, or requiring major surgery (e.g., elective joint replacement surgery) during the trial.
    27. Any mental disorder, including major depressive disorder and/or suicidal thoughts in anamnesis that can, in the Investigator's opinion, create a risk for the patient or influence the patient's ability to follow the study protocol.
    28. Myocardial infarction within less than 6 months prior to participation in the study.
    29. Severe central or peripheral nervous system diseases.
    30. Chronic drug or alcohol abuse.
    Known hypersensitivity to any components of the medications used in the study.
    32. Acute forms of any infectious diseases or history of chronic infections with severe clinical manifestations that would increase risk in participation of trial in the opinion of the Investigator.
    33. Presence of malignant neoplasm, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ and any malignancy with complete remission of more than 5 years.
    Attualmente sottoposti a trattamento concomitante con sulfasalazina o leflunomide. Nota: l’arruolamento è consentito dopo un appropriato periodo di wash-out (ovvero 5 emivite)
    2. Sono esclusi i pazienti attualmente sottoposti a infliximab EV o suo biosimilare approvato EV.
    3. Somministrazione di glucocorticoidi per via parenterale (IM, EV) ≥50 mg nelle 6 settimane o ≤50 mg nelle 4 settimane precedenti alla randomizzazione programmata, oppure somministrazioni programmate per via parenterale durante lo studio.
    4. Articolazione/i sottoposta/e a iniezioni intra-articolari di glucocorticoidi nelle 6 settimane precedenti la randomizzazione programmata.
    5. Malattia/e infiammatoria/e attiva/e delle articolazioni non correlate all’AR: gotta, artrite reattiva, artrite psoriasica, spondiloartropatia sieronegativa, malattia di Lyme.
    6. Malattia sistemica autoimmune diversa dall’AR: lupus eritematoso sistemico, morbo di Crohn, colite ulcerosa, sclerodermia sistemica, miopatia infiammatoria, forme miste di malattie infiammatorie del tessuto connettivo.
    7. Artrite idiopatica giovanile o AR giovanile e/o AR sviluppata prima dei 16 anni.
    8. Fibromialgia attiva che rende difficile per lo sperimentatore stabilire l’attività appropriata dell’AR.
    9. Pazienti con AR e classe funzionale IV secondo i criteri ACR 1991 (ovvero incapacità significativa o completa con autosufficienza scarsa o nulla, come allettato o su sedia a rotelle).
    10. Pazienti con infezioni gravi croniche o ricorrenti di entità virale, batterica, parassitaria o micotica
    11. Anamnesi di infezione attiva da virus dell’epatite B (HBV), virus dell’epatite C (HCV) o virus dell’immunodeficienza umana (HIV).
    12. Qualsiasi immunodeficienza congenita o acquisita confermata identificata..
    13. Valori anomali alle analisi di laboratorio
    Altre malattie somatiche instabili, a parte l’AR, che possono aumentare la probabilità di eventi avversi durante lo studio, mascherare, aumentare o alterare i sintomi dell’AR o determinare riscontri clinici o di laboratorio simili a quelli dell’AR.
    16. Intervento chirurgico maggiore nei 28 giorni precedenti la randomizzazione o necessità di intervento chirurgico maggiore (ad esempio chirurgia articolare sostitutiva elettiva) durante la sperimentazione.
    17. Qualsiasi malattia mentale, inclusi disturbi depressivi maggiori e/o pensieri suicidi nell’anamnesi che possano, a giudizio dello sperimentatore, creare un rischio per il paziente o influenzare la capacità del paziente di seguire il protocollo dello studio.
    18. Infarto del miocardio nei 6 mesi precedenti la partecipazione allo studio.
    19. Gravi malattie del sistema nervoso centrale o periferico.
    20. Abuso cronico di sostanze o alcol.
    21. Nota ipersensibilità a qualsiasi componente dei farmaci usati nello studio.
    22. Forme acute di qualsiasi malattia infettiva o anamnesi di infezioni croniche con gravi manifestazioni cliniche che potrebbero aumentare il rischio con la partecipazione alla sperimentazione secondo il giudizio dello sperimentatore.
    23. Presenza di neoplasia maligna, fatta eccezione per il carcinoma a cellule basali adeguatamente trattato e il carcinoma della cervice in situ e qualsiasi neoplasia maligna con remissione completa da oltre 5 anni.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, nature and severity of adverse events, including targeted adverse events, number of participants with SAEs, treatment-related SAEs, SAEs leading to discontinuation, treatment-related AEs, or AEs leading to discontinuation
    • Incidence of laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results
    • ECGs
    • Vital signs
    • Assessment of bone remodeling and cartilage markers (e.g., CTX-I, PINP and osteocalcin)
    • Assessment of blood cell markers (including, but not limited to, CD4, CD8, CD19, CD16/56, CD3, CD45, CD14)
    • Anti-drug antibodies (ADA)
    • Bone mineral density lumbar spine L1-L4 by dual energy X-ray absorptiometry (DEXA) scans
    Proportion of patients achieving an ACR50 response at Week 12
    Incidenza, natura e gravità degli eventi avversi, inclusi eventi avversi mirati, numero di partecipanti con eventi avversi seri (SAE), SAE correlati al trattamento, SAE che determinano l’interruzione, eventi avversi (AE) correlati al trattamento o AE che determinano l’interruzione
    • Incidenza dei valori anomali nelle analisi di laboratorio relative a ematologia, ematochimica clinica e risultati delle analisi delle urine
    • ECG
    • Segni vitali
    • Valutazione del rimodellamento osseo e dei marcatori della cartilagine (ad esempio CTX-I, PINP e osteocalcina)
    • Valutazione dei marcatori delle cellule ematiche (tra cui, senza limitazione, CD4, CD8, CD19, CD16/56, CD3, CD45, CD14)
    • Anticorpi anti-farmaco (ADA)
    • Densità minerale ossea del tratto lombare L1-L4 in base all’assorbimetria a raggi X a doppia energia (DEXA)
    Percentuale di pazienti che ottengono una risposta ACR50 alla Settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. Entro 36 sett
    3. Basale, sett 4, 12, 16, 24, 28
    4. Basale, sett. 2, 4, 6, 12, 16, 24, 28
    5. Basale, sett. 12, 16, 18
    6. Screening, sett 12, 14
    7. sett 12
    1-2. Entro 36 sett
    3. Basale, sett 4, 12, 16, 24, 28
    4. Basale, sett. 2, 4, 6, 12, 16, 24, 28
    5. Basale, sett. 12, 16, 18
    6. Screening, sett 12, 14
    7. sett 12
    E.5.2Secondary end point(s)
    • Change from baseline in CDAI Score at Week 12
    • Change from baseline in DAS28 at Week 12
    • Proportion of patients achieving DAS28 remission at Week 12
    • Proportion of patients achieving CDAI remission at Week 12
    • Proportion of patients achieving an ACR20 response at Week 12
    • Proportion of patients achieving an ACR70 response at Week 12
    • Simple Disease Activity Index (SDAI) Score at Week 12
    • Change from baseline in the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
    • Variazione dal basale nel punteggio CDAI alla Settimana 12
    • Variazione dal basale nel DAS28 alla Settimana 12
    • Percentuale di pazienti che ottengono una remissione DAS28 alla Settimana 12
    • Percentuale di pazienti che ottengono una remissione CDAI alla Settimana 12
    • Percentuale di pazienti che ottengono una risposta ACR20 alla Settimana 12
    • Percentuale di pazienti che ottengono una risposta ACR70 alla Settimana 12
    • Punteggio dell’indice semplificato di attività della malattia (SDAI) alla Settimana 12
    • Variazione dal basale nell’indice di disabilità del questionario di valutazione della salute di Stanford (HAQ-DI) alla Settimana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-2. Basale e sett 12
    3-7 sett 12
    8. Basale e sett 12
    9. Basale e sett 12, 14 (per liquido sinoviale), Basale e sett 2, 4, 8, 12, 16, 20, 24, 28 (per il siero)
    1-2. Basale e sett 12
    3-7 sett 12
    8. Basale e sett 12
    9. Basale e sett 12, 14 (per liquido sinoviale), Basale e sett 2, 4, 8, 12, 16, 20, 24, 28 (per il siero)
    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 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 trial5
    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 EEA31
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Austria
    Colombia
    Germany
    Guatemala
    Italy
    Mexico
    Peru
    Poland
    Spain
    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 years
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months22
    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: 174
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 204
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    No
    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 Decision2017-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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