Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42882   clinical trials with a EudraCT protocol, of which   7063   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-003558-26
    Sponsor's Protocol Code Number:ABX464-103
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 number2018-003558-26
    A.3Full title of the trial
    A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
    Studio di induzione randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli e a dose multipla per valutare la sicurezza, la tollerabilità e la dose ottimale di ABX464 rispetto al placebo in pazienti affetti da colite ulcerosa da moderata a grave che hanno una risposta inadeguata, perdita della risposta, o intolleranza ad almeno uno dei seguenti agenti: trattamento con farmaci immunosoppressori (ad es. azatioprina, 6-mercaptopurina, metotrexato), inibitori del fattore di necrosi tumorale alfa [TNF-a], vedolizumab, inibitori di JAK e/o trattamento con corticosteroidi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.
    Investigare sulla sicurezza e l'efficacia del farmaco in studio ABX464 rispetto al placebo in pazienti con colite ulcerosa da moderata a grave che hanno fallito in altri trattamenti.
    A.3.2Name or abbreviated title of the trial where available
    ABX464-103
    ABX464-103
    A.4.1Sponsor's protocol code numberABX464-103
    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 SponsorAbivax
    B.1.3.4CountryFrance
    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 supportABIVAX
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbivax
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address5 Rue dela Baume
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number0033153830961
    B.5.5Fax number000000000
    B.5.6E-mailPaul.Gineste@abivax.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 nameABX464
    D.3.2Product code [ABX464]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 nameABX464
    D.3.2Product code [ABX464]
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeABX464
    D.3.9.4EV Substance CodeSUB184487
    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.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, hard
    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
    Moderate to Severe Ulcerative Colitis
    Colite ulcerosa da moderata a grave
    E.1.1.1Medical condition in easily understood language
    In Ulcerative Colitis the lining of the colon becomes inflamed and develops tiny open sores that produce pus and mucous.This causes abdominal discomfort and frequent emptying of the colon (diarrhoea).
    Nella colite ulcerosa il rivestimento del colon si infiamma e sviluppa minuscole piaghe aperte che producono pus e muco. Questo provoca disagio addominale e frequenti svuotamenti del colon (diarrea).
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine an optimal ABX464 dose to be used in moderate to severe active ulcerative colitis patients who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab, JAK inhibitors and/or corticosteroids by comparing the mean change from baseline in the MMS at week 8 between each ABX464 group and placebo.
    L’obiettivo primario dello studio consiste nel determinare la dose ottimale di ABX464 da utilizzare nei pazienti con colite ulcerosa attiva da moderata a grave che non hanno risposto o sono intolleranti a immunomodulatori, anti-TNFa, vedolizumab, inibitori di JAK e/o corticosteroidi confrontando la variazione media dell’MMS rispetto al basale alla Settimana 8 tra ciascun gruppo ABX464 e placebo.
    E.2.2Secondary objectives of the trial
    ¿ To evaluate the global effect of ABX464 on MMS at Week (W) 8 and W16 and on partial Modified Mayo Score (MMS) at every study visit vs placebo.

    To evaluate the effect of the different dose groups of ABX464 vs placebo:
    ¿ on MMS at W16 and on partial MMS at every study visit.
    ¿ on clinical remission at W8 and at W16
    ¿ on clinical response at W8 and at W16
    ¿ on endoscopic improvement/remission, by segment, at W8 and W16
    ¿ on stool and rectal bleeding frequency at every study visit
    ¿ on fecal calprotectin and CRP levels at W8 and W16
    ¿ on miR-124 expression in tissue at W8 and W16 and in total blood at every timepoint
    ¿ on the rectal/sigmoidal infiltrates using the Robarts Histopathology Index at W8 and W16
    ¿ on Quality of Life measured by the IBDQ at W8 and W16
    ¿ on IL-6, TNFa, IL-1b, IL-10 plasma concentrations at every timepoint
    ¿ its safety profile
    ¿ To assess the pharmacokinetics of the ABX464 and its main active metabolite N-Glu-ABX464
    1) Valutare l'effetto glob di ABX464 su MMS alla settim (W) 8 e W16 e su Mayo Score (MMS) parziale modificato ad ogni visita studio vs placebo.

    2) l'effetto dei diversi gruppi di dosaggio di ABX464 risp al placebo:
    ¿Su MMS a W16 e su MMS parziale ad ogni visita.
    ¿Su remissione clinica al W8 e al W16
    ¿Su risposta clinica al W8 e al W16
    ¿Su miglioramento / remissione endoscopica, per segmento, a W8 e W16
    ¿Su feci e freq di sanguinam rettale ad ogni visita di studio
    ¿Su calprotectina fecale e livelli di CRP a W8 e W16
    ¿Su espress di miR-124 nel tessuto a W8 e W16 e nel sangue tot ad ogni punto temporale
    ¿Sugli infiltrati rettali/sigmoidali utilizzando l'indice di istopatologia di Robarts, le scale di valutaz dell'istologia di Geboes e Nancy a W8 e W16
    ¿Su Qual della vita misurata da IBDQ in W8 e W16
    ¿Su concentraz plasm di IL-6, TNFa, IL-1b, IL-10 ad ogni intervallo di tempo
    ¿Il suo profilo di sicurezza
    ¿Valutare la farmacocinetica di ABX464 e il suo princip metabolita attiv N-Glu-ABX464
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:
    - Men or women age 18 - 75 years;
    - Diagnosis of moderate to severe active UC confirmed by endoscopy and histology at least 12 Weeks prior to screening visit. Moderate to severe active UC defined by MMS of 4 to 9 inclusive (on a scale of 0-9). Moderate to severe active UC should be confirmed at screening visit with a centrally read endoscopy sub-score of at least 2 (on a scale of 0-3);
    - Patients having either a documented inadequate response, no response, a loss of response, or an intolerance to either immunosuppressant treatment, tumor necrosis factor [TNF] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.
    - Patients receiving oral corticosteroids must have been on a stable dose of prednisone or prednisone equivalent (<=16 mg/day) or on beclomethasone diproprionate (<=5mg/day) or on budesonide MMX (<=6mg/day) for at least 2 Weeks prior to the screening visit;
    - Topical corticosteroids and topical 5-aminosalicylic acid preparations must have been withdrawn at least 2 Weeks prior to the screening visit;
    - Patients who are on oral 5-aminosalicylic acid must have been on a stable dose for at least 4 Weeks prior to the screening visit;
    - Patients who are receiving immunosuppressants in the form of azathioprine, 6-mercaptopurine, or methotrexate needed to be on a stable dose for at least 4 Weeks prior to screening visit. Patients taking methotrexate also are advised to take folic acid 1 mg/day (or equivalent) supplementation if there is no contraindication;
    - Patients on probiotics must be on stable doses for at least 2 Weeks prior to the screening visit;
    - Patients on antidiarrheals must be on stable doses for at least 2 Weeks prior to the screening visit;
    - Patients who have received tumor necrosis factor [TNF] inhibitors, vedolizumab or other biologics must have discontinued therapy at least 8 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
    - Patients previously treated with cyclosporine, tacrolimus or JAK inhibitors must have discontinued therapy at least 4 Weeks prior to the screening visit due to lack or insufficient efficacy or intolerance;
    - Patients previously treated with tube feeding, defined formula diets, or parenteral alimentation/nutrition must have discontinued treatment 3 Weeks before the screening visit and must be able to take, orally, appropriate amount of food (calories) and liquids to maintain body weight;
    - Patients with surveillance colonoscopy defined as per ECCO guidelines;
    ¿ Patients with the following hematological and biochemical laboratory parameters obtained within 14 days prior to baseline:
    o Hemoglobin > 9.0 g dL-1;
    o Absolute neutrophil count >= 750 mm-3;
    o Platelets >= 100,000 mm-3;
    o Total serum creatinine <= 1.3 x ULN (upper limit of normal);
    o Creatinine clearance > 50 mL min-1 by the Cockcroft-Gault equation within 60 days prior to baseline;
    o Total serum bilirubin < 1.5 x ULN;
    o Alkaline phosphatase, AST (SGOT) and ALT (SGPT) < 2 x ULN;
    - Patients are able and willing to comply with study visits and procedures as per protocol;
    - Patients should understand, sign and date the written voluntary informed consent form at the screening visit prior to any protocol-specific procedures are performed;
    - Patients should be affiliated to a social security regimen (for French sites only);
    - Females and males receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 3 months after end of study or early termination. Contraception should be in place at least 2 Weeks prior to study participation.
    Un paziente sarà idoneo a partecipare a questo studio se TUTTI i seguenti criteri sono soddisfatti:
    - Uomini o donne di Età compresa tra 18 e 75 anni;
    - Diagnosi di UC attiva da moderata a grave confermata da endoscopia e istologia almeno 12 settimane prima della visita di screening. UC attiva da moderata a grave definita da MMS compreso tra 4 e 9 (su una scala da 0 a 9).
    - Pazienti con risposta inadeguata documentata, nessuna risposta, perdita di risposta o intolleranza al trattamento immunosoppressore, inibitori del fattore di necrosi tumorale [TNF], vedolizumab, inibitori della JAK e / o trattamento con corticosteroidi.
    - I pazienti trattati con corticosteroidi orali devono aver assunto una dose stabile di prednisone o di prednisone equivalente (<= 16 mg / die) o di beclometasone diproprionato (<= 5 mg / die) o di budesonide MMX (<= 6 mg / die) per almeno 2sett prima alla visita di screening;
    - I corticosteroidi topici e i preparati topici di acido 5-aminosalicilico devono essere stati prelevati almeno 2sett prima della visita di screening;
    - I pazienti che assumono acido 5-aminosalicilico orale devono aver assunto una dose stabile per almeno 4sett prima della visita di screening;
    - I pazienti che assumono immunosoppressori sotto forma di azatioprina, 6-mercaptopurina o metotrexato devono essere sottoposti a una dose stabile per almeno 4sett prima della visita di screening. I pazienti che assumono metotrexato sono anche invitati ad assumere un supplemento di acido folico 1 mg / die (o equivalente) se non ci sono controindicazioni;
    - I pazienti con probiotici devono essere sottoposti a dosi stabili per almeno 2sett prima della visita di screening;
    - I pazienti con antidiarroici devono assumere dosi stabili per almeno 2sett prima della visita di screening;
    - I pazienti che hanno ricevuto inibitori del TNF, vedolizumab o altri farmaci biologici devono aver interrotto la terapia almeno 8sett prima della visita di screening a causa di carenza o insufficienza di efficacia o intolleranza;
    - I pazienti precedentemente trattati con ciclosporina, tacrolimus o inibitori della JAK devono aver interrotto la terapia almeno 4sett prima della visita di screening a causa di carenza o insufficienza di efficacia o intolleranza;
    - I pazienti precedentemente trattati con alimentazione con sondino, diete a formula definita o alimentazione / nutrizione parenterale devono avere interrotto il trattamento 3sett prima della visita di screening e devono essere in grado di assumere, oralmente, una quantità appropriata di cibo (calorie) e liquidi per mantenere il peso corporeo;
    - Pazienti con colonscopia di sorveglianza definiti secondo le linee guida ECCO;
    - Pazienti con i seguenti parametri ematologici e di laboratorio biochimici ottenuti entro 14g prima del basale:
    o Emoglobina> 9,0 g dL-1;
    o Conteggio assoluto dei neutrofili >= 750 mm-3;
    o piastrine >= 100.000 mm-3;
    o creatinina sierica totale <= 1,3 x ULN (limite superiore del normale);
    o clearance della creatinina> 50 mL min-1 dall'equazione di Cockcroft-Gault entro 60g prima della linea di base;
    o bilirubina totale sierica <1,5 x ULN;
    o fosfatasi alcalina, AST (SGOT) e ALT (SGPT) <2 x ULN;
    - I pazienti sono in grado e disposti a rispettare visite e procedure di studio come da protocollo;
    - I pazienti devono comprendere, firmare e datare il modulo di consenso informato volontario scritto alla visita di screening prima che vengano eseguite le procedure specifiche del protocollo;
    - I pazienti devono essere affiliati a un regime di sicurezza sociale (solo per i siti francesi);
    - Le donne ei maschi che ricevono il trattamento di studio e i loro partner devono accettare di utilizzare un metodo contraccettivo altamente efficace durante lo studio e per 3m dopo la fine dello studio o la risoluzione anticipata. La contraccezione dovrebbe essere in atto almeno 2sett prima della partecipazione allo studio.
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
    ¿ Patients with Crohn's Disease (CD) or presence or history of fistula, indeterminate colitis (IC), infectious/ischemic colitis or microscopic colitis (lymphocytic and collagenous colitis);
    ¿ History of toxic megacolon, abdominal abscess, symptomatic colonic stricture or stoma; history or imminent colectomy, colonic malignancy;
    ¿ History or current evidence of colonic dysplasia or adenomatous colonic polyps. Patient with severe gastrointestinal complications; e.g., short bowel syndromes, recent or planned bowel surgery, Ileostomy and/or colostomy, recent bowel perforation;
    ¿ History of more than one episode of herpes zoster or a history (single episode) of disseminated zoster;
    ¿ Patients with known active infections at screening such as infected abdominal abscess, Clostridium difficile (stool antigen and toxin required), CMV, TB colitis and recent infectious hospitalization;
    ¿ Patients previously treated with ABX464;
    ¿ Acute, chronic or history of clinically relevant pulmonary, cardiovascular, hepatic, pancreatic or renal functional abnormality, encephalopathy, neuropathy or unstable CNS pathology such as seizure disorder, angina or cardiac arrhythmias, active malignancy or any other clinically significant medical problems as determined by physical examination and/or laboratory screening tests and/or medical history;
    ¿ Acute, chronic or history of immunodeficiency or autoimmune disease;
    ¿ History of malignancy excluding patients considered cured (5 years disease free survivors);
    ¿ Serious illness requiring systemic treatment and/or hospitalization within 3 Weeks prior to baseline;
    ¿ Pregnant or breast-feeding women;
    ¿ Illicit drug or alcohol abuse or dependence;
    ¿ Use of any investigational or non-registered product within 3 months preceding baseline;
    ¿ Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
    I pazienti che soddisfano uno dei seguenti criteri di esclusione saranno esclusi dallo studio:
    ¿Pazienti con malattia di Crohn (CD) o presenza o storia di fistola, colite indeterminata (IC), colite infettiva / ischemica o colite microscopica (colite linfocitica e collagene);
    ¿Storia di megacolon tossico, ascesso addominale, stenosi del colon sintomatica o stoma; storia o colectomia imminente, neoplasia colica;
    ¿Storia o evidenza attuale di displasia del colon o polipi adenomatosi del colon. Paziente con gravi complicazioni gastrointestinali; per esempio, sindromi intestinali corte, intervento chirurgico intestinale recente o programmato, Ileostomia e / o colostomia, recente perforazione intestinale;
    ¿Storia di più di un episodio di herpes zoster o di una storia (episodio singolo) di zoster disseminato;
    ¿Pazienti con infezioni attive conosciute allo screening come ascesso addominale infetto, Clostridium difficile (antigene fecale e tossina necessaria), CMV, colite TB e recente ospedalizzazione infettiva;
    ¿Pazienti precedentemente trattati con ABX464;
    ¿Acuta, cronica o storia di anormalità funzionale polmonare, cardiovascolare, epatica, pancreatica o renale clinicamente rilevante, encefalopatia, neuropatia o patologia del SNC instabile come disturbi convulsivi, angina o aritmie cardiache, neoplasie attive o altri problemi medici clinicamente significativi come determinato da esame fisico e / o prove di screening di laboratorio e / o anamnesi;
    ¿Acuta, cronica o storia di immunodeficienza o malattia autoimmune;
    ¿Storia di neoplasie maligne escluse quelle considerate guarite (5 anni sopravvissuti alla malattia);
    ¿Malattia grave che richiede un trattamento sistemico e / o ospedalizzazione entro 3 settimane prima del basale;
    ¿Donne incinte o che allattano;
    ¿Illecito abuso di droga o alcol o dipendenza;
    ¿Uso di qualsiasi prodotto sperimentale o non registrato entro 3 mesi precedenti la baseline;
    Qualsiasi condizione, che secondo il parere dello sperimentatore, potrebbe compromettere la sicurezza del paziente o l'aderenza al protocollo dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction from baseline in Modified Mayo Score at Week 8.
    Riduzione dalla linea di base nel punteggio di Mayo modificato alla settimana 8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 8
    Alla settimana 8
    E.5.2Secondary end point(s)
    ¿ Number and rate of patients in clinical remission at the end of Week 8, per each intervention/treatment group. Clinical remission, based on the Mayo Scoring system, is defined as a rectal bleeding sub-score = 0 and an Endoscopy sub-score <=1 (excluding friability) and at least one-point decrease in stool frequency sub score from baseline to achieve a stool frequency sub-score <=1
    ¿ Combined number and rate of patients in clinical remission at Week 8 and at Week 16, per each intervention/treatment group.
    ¿ Number and rate of patients with clinical response at Week 8 and Week 16 per intervention/treatment group. Clinical Response is defined as a reduction in Mayo Score of at least 2 points and greater than or equal to 30 percent from baseline with an accompanying decrease in rectal bleeding sub-score of greater than or equal to 1 point or absolute rectal bleeding sub-score of less than or equal to 1 point.
    ¿ Number and rate of patients with endoscopic improvement, by segment, and number and rate of patients with endoscopic remission, by segment, at Week 8 and at Week 16 (if available) per intervention/treatment group. Endoscopic improvement is defined as a Mayo endoscopic sub score of <=1 (excluding friability) and endoscopic remission defined as sub score of 0.
    ¿ Reduction relative to baseline in stool and rectal bleeding frequency at every study visit by ABX464 dose group and versus placebo.
    ¿ Reduction relative to baseline in partial Modified Mayo Score at every study visit and Modified Mayo Score at Week 16 (if available) by ABX464 dose group and versus placebo.
    ¿ Reduction relative to baseline in fecal calprotectin and CRP levels at Week 8 and Week 16 by intervention/treatment group.
    ¿ Change relative to baseline in miRNA-124 expression in rectal/sigmoidal biopsies at Week 8 and Week 16 and in total blood at every timepoints by intervention/treatment group.
    ¿ The scores and changes from baseline in IBDQ at Week 8 and Week 16 per intervention treatment group.
    ¿ Reduction relative to baseline of infiltrate/histopathology (rectal/sigmoidal biopsies) using the Robarts Histopathology Index (RHI), the Geboes and Nancy Histology Scoring Scales at Week 8 and Week 16 (if available) per intervention/treatment group.
    ¿ Change relative to baseline in IL-6, TNFa, IL-1b, IL-10 plasma concentrations at every timepoints by intervention/treatment group.
    ¿ Serum concentration of ABX464 and N-Glu ABX464 according to dose group.
    ¿ Number and rate of all adverse events, causally-related adverse events, all SAE and causally-related SAEs classified by severity per intervention/treatment group.
    ¿ Incidence of treatment-emergent serious adverse event per intervention/treatment group.
    ¿ Incidence of adverse events leading to investigational product discontinuation per intervention/treatment group.
    ¿ The number of clinically-significant laboratory abnormalities per intervention/treatment group.; ¿Numero e percentuale di pazienti in remissione clinica alla fine della settimana 8, per ciascun gruppo di intervento / trattamento. La remissione clinica, basata sul sistema di punteggio di Mayo, è definita come un sottotesto di sanguinamento rettale = 0 e un sottogruppo di endoscopia <= 1 (friabilità esclusa) e almeno una diminuzione di un punto nel punteggio sub di frequenza delle feci rispetto al basale per ottenere un sub-score di frequenza delle feci <= 1
    ¿Numero combinato e tasso di pazienti in remissione clinica alla settimana 8 e alla settimana 16, per ciascun gruppo di intervento / trattamento.
    ¿Numero e velocità dei pazienti con risposta clinica alla settimana 8 e alla settimana 16 per gruppo di intervento / trattamento. La risposta clinica è definita come una riduzione del punteggio di Mayo di almeno 2 punti e maggiore o uguale al 30 percento rispetto al basale con una diminuzione accompagnatoria del sottotesto emorragico rettale superiore o uguale a 1 punto o sanguinamento rettale assoluto sub-score inferiore o uguale a 1 punto.
    ¿Numero e velocità dei pazienti con miglioramento endoscopico per segmento e numero e velocità dei pazienti con remissione endoscopica, per segmento, alla settimana 8 e alla settimana 16 (se disponibile) per gruppo di intervento / trattamento. Il miglioramento endoscopico è definito come un sottotesto endoscopico Mayo di <= 1 (esclusa friabilità) e la remissione endoscopica definita come sub punteggio di 0.
    ¿Riduzione rispetto al basale delle feci e frequenza del sanguinamento rettale ad ogni visita di studio dal gruppo di dosaggio ABX464 e rispetto al placebo.
    ¿Riduzione rispetto al basale nel punteggio di Mayo modificato parziale ad ogni visita di studio e punteggio Mayo modificato alla settimana 16 (se disponibile) dal gruppo di dosaggio ABX464 e rispetto al placebo.
    ¿Riduzione rispetto al basale nei livelli di calprotectina fecale e CRP alla settimana 8 e alla settimana 16 per gruppo di intervento / trattamento.
    Cambiamento rispetto al basale nell'espressione del miRNA-124 nelle biopsie rettali /
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. at the end of Week 8, per each intervention/treatment group
    2. at Week 8 and at Week 16, per each intervention/treatment group
    3. at Week 8 and at Week 16, per each intervention/treatment group
    4. at Week 8 and at Week 16 (if available) per intervention/treatment group
    5. at every study visit by ABX464 dose group and versus placebo
    6. at Week 16 (if available) by ABX464 dose group and versus placebo
    7. at Week 8 and Week 16 by intervention/treatment group
    8. in rectal/sigmoidal biopsies at Week 8 and Week 16 and in total blood at every timepoints by intervention/treatment group
    9. at Week 8 and Week 16
    10. at Week 8 and Week 16 (if available)
    11. at every timepoints
    12. through the study
    13. through the study
    14.through the study
    15.through the study
    16.through the study
    1. alla fine della set 8, per tutti
    2. alla set 8 e alla set 16, per tutti
    3. alla set 8 e alla set 16, per tutti
    4. alla set 8 e alla set 16 per gruppo di intervento/trattamento
    5. ad ogni visita di studio dal gruppo di dosaggio ABX464 e rispetto al placebo
    6. alla set 16 dal gruppo di dosaggio ABX464 e rispetto al placebo
    7. alla set 8 e alla set 16 dal gruppo di intervento/trattamento
    8. in biopsie rettali / sigmoidali alla set 8 e alla set 16 e nel sangue totale in ogni momento del ciclo di intervento/trattamento
    9. alla set 8 e alla set 16
    10. alla set 8 e alla set 16
    11. ad ogni orario
    12. durante lo studio
    13. durante lo studio
    14. durante lo studio
    15. durante lo studio
    16. durante lo studio
    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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belarus
    Belgium
    Canada
    Czechia
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Poland
    Serbia
    Slovakia
    Slovenia
    Spain
    Ukraine
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 220
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 202
    F.4.2.2In the whole clinical trial 232
    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 Week 16, patients willing to continue the study treatment will be eligible for enrollment in an open label extension (will be submitted through another protocol)
    Alla settimana 16, i pazienti disposti a continuare il trattamento in studio saranno idonei per l'arruolamento in un'estensione in aperto (sarà presentata tramite un altro 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 Decision2019-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA