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    Summary
    EudraCT Number:2021-000091-11
    Sponsor's Protocol Code Number:PR200-102
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-02
    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 number2021-000091-11
    A.3Full title of the trial
    A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
    Studio di fase 2, multicentrico, in doppio cieco, controllato con placebo per valutare la sicurezza, l’efficacia e la farmacocinetica della terapia di induzione con PRA023 nei soggetti affetti da colite ulcerosa da moderatamente a gravemente attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of efficacy of PRA023 in patients with Ulcerative Colitis
    Uno studio dell'efficacia del PRA023 in pazienti con colite ulcerosa
    A.3.2Name or abbreviated title of the trial where available
    ARTEMIS-UC Study
    Studio ARTEMIS-UC
    A.4.1Sponsor's protocol code numberPR200-102
    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 SponsorPrometheus Biosciences Inc.
    B.1.3.4CountryUnited States
    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 supportPrometheus Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrometheus Biosciences, Inc.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address9410 Carroll Park Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.6E-mailmm@prometheusbiosciences.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 namePRA023
    D.3.2Product code [PRA023]
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePRA023
    D.3.9.3Other descriptive namePRA023
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 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
    Ulcerative Colitis
    Colite Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the colon resulting in abdominal pain and bloody diarrhea.
    La colite ulcerosa è una forma di malattia infiammatoria intestinale (IBD) che provoca infiammazione e ulcere nel colon con conseguente dolore addominale e diarrea sanguinolenta.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    1. To assess the safety and tolerability of PRA023 following 12-weeks of induction therapy
    2. To compare the efficacy of PRA023 vs placebo for induction of clinical remission at Week 12


    1. • Valutare la sicurezza e la tollerabilità di PRA023 dopo 12 settimane di terapia di induzione
    2. • Confrontare l’efficacia di PRA023 rispetto al placebo per l’induzione della remissione clinica alla Settimana 12
    E.2.2Secondary objectives of the trial
    Compare the efficacy of PRA023 vs placebo for induction of:
    - endoscopic improvement
    - clinical response
    - histologic remission
    - histologic-endoscopic mucosal improvement
    - mucosal healing

    Compare the efficacy of PRA023 vs placebo for change in IBDQ

    Compare the efficacy of PRA023 vs placebo in subjects who are companion diagnostic positive (CDx+) for induction of:
    - clinical remission
    - endoscopic improvement
    - clinical response
    - histologic remission
    - histologic-endoscopic mucosal improvement
    - mucosal healing

    Compare the efficacy of PRA023 in CDx+ vs CDx- subjects for induction of clinical remission.

    Compare the efficacy of PRA023 vs placebo for change in IBDQ
    Compare the efficacy of PRA023 vs placebo in CDx+ subjects for change in IBDQ
    Confrontare l'efficacia di PRA023 rispetto al placebo per l'induzione di:
    - miglioramento endoscopico
    - risposta clinica
    - remissione istologica
    - miglioramento istologico-endoscopico della mucosa
    - guarigione delle mucose

    Confronta l'efficacia di PRA023 rispetto al placebo per il cambiamento di IBDQ

    Confrontare l'efficacia di PRA023 rispetto al placebo in soggetti che sono positivi alla diagnosi di accompagnamento (CDx+) per l'induzione di:
    - remissione clinica
    - miglioramento endoscopico
    - risposta clinica
    - remissione istologica
    - miglioramento istologico-endoscopico della mucosa
    - guarigione delle mucose

    Confrontare l'efficacia del PRA023 nei soggetti CDx+ rispetto a quelli CDx- per l'induzione della remissione clinica.

    Confronta l'efficacia di PRA023 rispetto al placebo per il cambiamento di IBDQ
    Confronta l'efficacia di PRA023 rispetto al placebo nei soggetti CDx+ per il cambiamento di IBDQ
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Pharmacokinetics Sub-study, 18-06-2021, v 2.0

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di farmacocinetica, 18-06-2021, v 2.0
    E.3Principal inclusion criteria
    1. Male or female >=18 years of age
    2. Subjects must have had a documented diagnosis of UC (endoscopy + histology) to be eligible for study participation or UC diagnosis must be confirmed at time of screening colonoscopy
    3. Moderately to severely active UC
    4. Subjects must satisfy at least one of the following criteria:
    a) In the past, had an inadequate response to one or more of the following treatments:
    i. Oral prednisone, budesonide for at least 2 weeks
    ii. Corticosteroid dependence as defined by failed to successfully taper to < 10 mg/day of prednisone equivalent within 3 months of starting therapy, or if relapse occurs within 3 months of stopping corticosteroids
    iii. Immunosuppressants for at least 12 weeks
    iv. An approved anti-TNF agent at an approved labeled dose for at least 8 weeks
    v. Vedolizumab at the approved labelled dose for at least 8 weeks
    vi. An approved JAK inhibitor for at least 8 weeks
    vii. An approved anti-IL-12/23 for at least 8 weeks
    viii. An approved sphingosine 1-phosphate receptor (S1PR) modulator for least 12 weeks
    OR
    b) Had been intolerant to one or more of the above-mentioned treatments (e.g., unable to achieve doses or treatment durations because of dose limiting side effects [e.g., leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes]).
    OR
    c) Currently receiving one or more of the following treatments:
    i. Oral Prednisone = 10 mg/day (or equivalent) for at least 3months
    ii. Immunosuppressants [azathioprine = 2 mg/kg/day or 6-mercaptopurine = 1.0 mg/kg/day (or documentation of a therapeutic concentration of 6 thioguanine nucleotide)] for at least 8 weeks
    Notes on subjects who have had prior biologic/biologic-like therapy(ies) (anti-TNF, JAK inhibitor, anti-IL-23, and/or anti-integrin):
    i. The study will include a maximum of 70% subjects who have had prior biologic/biologic-like therapy(ies) experience. Upon reaching the maximum number of allowed biologic/biologic-like experienced subjects (70%), subjects who have had prior biologic/biologic-like experience will no longer be allowed to enter the study.
    ii. Subject cannot have failed (no response, insufficient response, loss of response, and/or intolerance) > 3 classes or > 4 individual biologic/biologic-like therapies (exclusion criterion #26).
    5. For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug.
    6. Male subjects must use two highly effective methods of contraception from screening to 12 weeks after the last dose of study drug.
    7. Subject must meet drug stabilization requirements, as applicable:
    a) Oral corticosteroid treatment must have been reduced to the equivalent of = 20 mg prednisone or = 9 mg budesonide daily at a stable dose for at least 2 weeks prior to randomization.
    b) Oral aminosalicylates should be at a stable dose for at least 2 weeks prior to randomization.
    c) Azathioprine and 6-mercaptopurine should be at a stable dose for at least 4 weeks prior to randomization.
    8. Able to provide written informed consent and understand and comply with the requirements of the study.
    1.sesso maschile o femminile di età >=18 anni
    2.aver ricevuto una diagnosi documentata di CU o confermare la diagnosi di CU al momento della colonscopia di screening
    3.CU da moderatamente a gravemente attiva.
    4.soddisfare almeno uno dei seguenti criteri:
    a)Pregressa risposta inadeguata ad almeno uno dei seguenti trattamenti:
    i.Prednisone orale, budesonide, equivalente, beclometasone
    ii. Dipendenza da corticosteroidi definita dall’insuccesso nella riduzione della dose a <10 mg/die di prednisone o equivalente (dovuto al riacutizzarsi della malattia) entro 3 mesi dall’inizio della terapia o dal verificarsi di una recidiva entro 3 mesi dall’interruzione dei corticosteroidi
    iii. Immunosoppressori per almeno 8 settimane
    iv. Un agente anti-fattore di necrosi tumorale (TNF) approvato, a una dose in etichetta approvata, per almeno 8 settimane
    v. Vedolizumab, alla dose in etichetta approvata, per almeno 8 settimane
    vi. Un inibitore delle Janus chinasi (JAK) approvato a una dose in etichetta approvata, per almeno 8 settimane
    vii. Un anti-interleuchina-12/23 (IL-12/23) approvato, a una dose in etichetta approvata, per almeno 8 settimane
    viii. Un modulatore del recettore della sfingosina-1-fosfato (S1PR) approvato, a una dose in etichetta approvata, per almeno 12 settimane
    O
    b) Intolleranza ad almeno uno dei trattamenti summenzionati
    O
    c) Corrente utilizzo di almeno uno dei seguenti trattamenti:
    i. Prednisone orale =10 mg/die (o equivalente) da almeno 3 mesi
    ii. Immunosoppressori da almeno 8 settimane
    Note su soggetti che hanno ricevuto precedenti terapie biologiche/simil-biologiche (anti-TNF, inibitori di JAK, modulatori della S1PR, anti-IL-12/23 e/o vedolizumab):
    i. Massimo il 70% dei soggetti dello studio avrà avuto una precedente esperienza con terapie biologiche/simil-biologiche. Al raggiungimento del numero massimo di soggetti con esperienza biologica/simil-biologica ammessi (70%), non sarà più consentito l’ingresso nello studio a soggetti con una precedente esperienza biologica/simil-biologica.
    ii. Il soggetto non può non aver risposto (nessuna risposta, risposta insufficiente, perdita di risposta e/o intolleranza) a un numero >3 classi o > 4 singole terapie biologiche/simil-biologiche (si rimanda al criterio di esclusione n. 26).
    5. Per i soggetti di sesso femminile fertili (WOCBP) con rapporti sessuali che potrebbero portare a una gravidanza, il soggetto ha utilizzato due metodi contraccettivi altamente efficaci per almeno le 4 settimane precedenti il Giorno 1 e accetta di continuare a utilizzare due metodi contraccettivi altamente efficaci fino ad almeno 12 settimane dopo l’ultima dose del farmaco dello studio.
    6. I soggetti di sesso maschile, insieme alle loro partner di sesso femminile fertili, devono utilizzare due metodi contraccettivi altamente efficaci e astenersi dal donare sperma dallo screening fino a 12 settimane dopo l’ultima dose del farmaco dello studio.
    7. Il soggetto deve soddisfare i requisiti di stabilizzazione del farmaco, come pertinente:
    a) Il trattamento con corticosteroidi orali deve essere equivalente a =20 mg di prednisone o =9 mg di budesonide o beclometasone <5 mg al giorno a una dose stabile da almeno le 2 settimane precedenti la randomizzazione
    b) Gli aminosalicilati orali devono essere stati assunti a una dose stabile da almeno le 2 settimane precedenti la randomizzazione
    c) Azatioprina e 6-mercaptopurina devono essere state assunte a una dose stabile da almeno le 4 settimane precedenti la randomizzazione
    8. Capacità di fornire il consenso informato scritto e comprendere e rispettare i requisiti dello studio.
    E.4Principal exclusion criteria
    -WOCBP and men with fertile partners who do not wish or cannot use two methods of contraception
    - Women who are pregnant or breastfeeding.
    - Women with a positive pregnancy test at enrollment or before randomization.
    - Diagnosis of Crohn's disease or indeterminate colitis.
    -CU limited to the rectum.
    -Current evidence of fulminant colitis, toxic megacolon or intestinal perforation.
    -Current or imminent need for colostomy or ileostomy.
    - Previous total proctocolectomy or partial colectomy.
    -Surgical bowel resection within 3 months prior to screening.
    - Concomitant primary sclerosing cholangitis (CSP).
    - Previous or current evidence of low or high-grade colon dysplasia that has not been completely removed.
    - Subjects with scheduled or foreseeable surgery, with the exception of dermatological procedures.
    - Individuals with a history of clinically significant drug or alcohol abuse.
    - Concomitant disease which may require systemic glucocorticosteroid therapy during the study
    - Concomitant medical conditions that could expose the subject to an unacceptable risk for participation in this study.
    - a history of cancer within the past 5 years. Any non-melanomatous skin cell tumors that may be present must be removed before enrollment. Subjects with carcinoma in situ or localized cervical cancer, treated with definitive surgery, are admitted.
    - at risk of tuberculosis (TB), active or not successfully treated.
    - with any severe bacterial infection within the past 3 months or any chronic bacterial infection
    - screened for breast cancer suspected of being malignant and for which malignancy cannot reasonably be excluded
    -affected with active infection prior to randomization.
    - with reactivation of herpes zoster or CMV resolved less than 2 months before the signing of the ICF.
    - Get vaccinated with live vaccine within 3 months prior to the first dose of the drug or that they will need it
    - PCR positive stool or positive fecal culture for enteric pathogens.
    -Feces positive for C. difficile toxin.
    - Any of the following values
    - Hemoglobin <8.0 g / dl
    - White blood cells <2,500 / mm3
    - Neutrophils <1,000 / mm3
    - Platelets <100,000 / mm3
    - Serum creatinine> 2 times the limit
    - Alanine aminotransferase or serum aspartate aminotransferase> 2 times the ULN
    - Failure to respond to> 3 classes (anti-TNF, anti-integrin, anti-IL-12/23, JAK inhibitor, S1PR modulator) or> 4 single biological / biological-like therapies.
    -Any biological or biologic-like marketed drug within 2 weeks for tofacitinib, 8 weeks for anti-TNF agents, 10 weeks for S1PR modulators, and 12 weeks for vedolizumab and ustekinumab prior to randomization
    - Any biological immunomodulator not included in exclusion criterion 27
    -Rituximab within 1 year prior to randomization.
    - Parenteral corticosteroids within 4 weeks or rectal corticosteroid administration within 2 weeks prior to randomization.
    -Rectal administration of 5-aminosalicylic acid (5-ASA) within 2 weeks prior to randomization.
    -Tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, immunosorbent columns, D-Penicillamine, Leflunomide, Thalidomide, fish oil preparations, probiotics, fecal transplant, non-steroidal anti-inflammatory agents (NSAIDs), aspirin.
    -Other experimental chemical agent in the 30 days or other experimental biological agent in the 8 weeks or 5 half-lives prior to randomization.
    -Previous exposure to PRA023.
    -WOCBP e uomini con partner fertili che non desiderano o non possono utilizzare due metodi contraccettivi
    -Donne in gravidanza o in fase di allattamento.
    -Donne con test di gravidanza positivo all’arruolamento o prima della randomizzazione.
    -Diagnosi di malattia di Crohn o colite indeterminata.
    -CU limitata al retto.
    -Attuale evidenza di colite fulminante, megacolon tossico o perforazione intestinale.
    -Necessità attuale o imminente di colostomia o ileostomia.
    -Precedente proctocolectomia totale o colectomia parziale.
    -Resezione intestinale chirurgica nei 3 mesi precedenti lo screening.
    -Colangite sclerosante primitiva (CSP) concomitante.
    -Evidenza pregressa o attuale di displasia del colon definita di basso o alto grado non completamente rimossa.
    -Soggetti con intervento chirurgico programmato o prevedibile, a eccezione delle procedure dermatologiche.
    -Soggetti con anamnesi di abuso clinicamente significativo di droghe o alcol.
    -Malattia concomitante che, potrebbe richiedere una terapia sistemica con glucocorticosteroidi durante lo studio
    -Condizioni mediche concomitanti che potrebbero esporre il soggetto a un rischio inaccettabile per la partecipazione a questo studio.
    -anamnesi di tumore negli ultimi 5 anni. I tumori cellulari cutanei non melanomatosi eventualmente presenti devono essere rimossi prima dell’arruolamento. Sono ammessi i soggetti con carcinoma in situ o tumore cervicale localizzato, trattati con intervento chirurgico definitivo.
    -a rischio di tubercolosi (TBC), attiva o non trattata con successo.
    -con qualsiasi infezione batterica grave negli ultimi 3 mesi o qualsiasi infezione batterica cronica
    -sottoposti a screening per un tumore mammario di cui si sospetta la malignità e per i quali non sia possibile escludere ragionevolmente la malignità
    -affetti da infezione attive prima della randomizzazione.
    -con riattivazione dell’herpes zoster o CMV risolta meno di 2 mesi prima della firma del ICF.
    -Vaccinati con vaccino vivo nei 3 mesi precedenti la prima dose del farmaco o che ne avranno bisogno
    -Feci positive al test PCR o coltura fecale positiva per patogeni enterici.
    -Feci positive per la tossina del C. difficile.
    -Uno qualsiasi dei seguenti valori
    --Emoglobina <8,0 g/dl
    --Globuli bianchi <2.500/mm3
    --Neutrofili <1.000/mm3
    --Piastrine <100.000/mm3
    --Creatinina sierica >2 volte il limite
    --Alanina aminotransferasi o aspartato aminotransferasi sierici >2 volte l’ULN
    -Mancata risposta a un numero >3 classi (anti-TNF, anti-integrina, anti-IL-12/23, inibitore di JAK, modulatore della S1PR) o >4 singole terapie biologiche/simil-biologiche.
    -Qualsiasi farmaco biologico o simil-biologico in commercio entro 2 settimane per tofacitinib, 8 settimane per gli agenti anti-TNF, 10 settimane per i modulatori della S1PR e 12 settimane per vedolizumab e ustekinumab prima della randomizzazione
    -Qualsiasi immunomodulatore biologico non incluso nel criterio di esclusione 27
    -Rituximab entro 1 anno prima della randomizzazione.
    -Corticosteroidi per via parenterale entro 4 settimane o somministrazione rettale di corticosteroidi entro 2 settimane prima della randomizzazione.
    -Somministrazione rettale di acido 5-aminosalicilico (5-ASA) nelle 2 settimane precedenti la randomizzazione.
    -Tacrolimus, metotrexato, ciclosporina, micofenolato mofetile, colonne per l’immunoassorbimento, D-Penicillamina, Leflunomide, Talidomide, preparazioni di olio di pesce, probiotici, trapianto fecale, agenti antinfiammatori non steroidei (FANS), aspirina.
    -Altro agente chimico sperimentale nei 30 giorni o altro agente biologico sperimentale nelle 8 settimane o 5 emivite precedenti la randomizzazione.
    -Precedente esposizione a PRA023.
    E.5 End points
    E.5.1Primary end point(s)
    1. The proportion of subjects reporting adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values.
    2. The proportion of subjects in the 3-component Modified Mayo Score clinical remission (as defined by endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and stool frequency subscore of 0 or 1 and not greater than Baseline) at Week 12. The 3-component Modified Mayo Score ranges from 0-9 and includes rectal bleeding, stool frequency and endoscopic assessment domains.
    1. Percentuale di soggetti che segnalano eventi avversi (EA), eventi avversi seri (SAE), EA che portano all’interruzione e valori di laboratorio marcatamente anomali.
    2. Percentuale di soggetti nella remissione clinica del punteggio Mayo modificato a 3 componenti (definita da un sottopunteggio endoscopico di 0 o 1, sottopunteggio di sanguinamento rettale di 0 e sottopunteggio di frequenza delle feci di 0 o 1 e non superiore al Basale) alla Settimana 12. Il punteggio Mayo modificato a 3 componenti varia da 0 a 9 e comprende i domini relativi a sanguinamento rettale, frequenza delle feci e valutazione endoscopica.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.5.2Secondary end point(s)
    1. The proportion of subjects with endoscopic improvement, as defined by endoscopy subscore =1 with no friability) at Week 12.
    2. The proportion of subjects in 3-component Modified Mayo Score clinical response at Week 12. The 3-component Modified Mayo Score clinical response is defined by reduction from Baseline =2 points and =30% in modified Mayo Score, accompanied by a reduction = 1 in rectal bleeding subscore or absolute rectal bleeding subscore =1.
    3. The proportion of subjects in the 3-component Modified Mayo Score clinical remission (as defined by endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and stool frequency subscore of 0 or 1 and not greater than Baseline), in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12. The 3-component Modified Mayo Score ranges from 0-9 and includes rectal bleeding, stool frequency and endoscopic assessment domains.
    4. The proportion of subjects with histologic remission (defined Geboes score =3.1) at Week 12.
    5. The proportion of subjects with histologic-endoscopic mucosal improvement (defined as Geboes score =3.1 and endoscopy subscore =1 with no friability) at Week 12.
    6. The proportion of subjects with endoscopic improvement, as defined by endoscopy subscore =1 with no friability, in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    7. The proportion of subjects in 3-component Modified Mayo Score clinical response in CDx+ subjects treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12. The 3-component Modified Mayo Score clinical response is defined by reduction from Baseline = 2 points and = 30% in modified Mayo Score, accompanied by a reduction = 1 in rectal bleeding subscore or absolute rectal bleeding subscore = 1.
    8. The proportion of subjects with histologic remission, defined as Geboes score =3.1, in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    9. The proportion of subjects with histologic-endoscopic mucosal improvement (defined as Geboes score =3.1 and endoscopy subscore =1 with no friability), in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    10. The proportion of subjects with clinical remission (defined as endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and stool frequency subscore of 0 or 1 and not greater than Baseline) in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to in CDx- subjects treated with PRA023 at Week 12.
    11. The proportion of subjects with mucosal healing (defined as Geboes score =2B.1 and endoscopy subscore of = 1) at Week 12.
    12. The proportion of subjects with mucosal healing (defined as Geboes score =2B.1 and endoscopy subscore of = 1), in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    13. The proportion of subjects with IBDQ response, as defined by = 16-point increase from Baseline at Week 12.
    14. The proportion of subjects with IBDQ response, as defined by = 16-point increase from Baseline, in CDx+ subjects (Cohort 1 + Cohort 2) treated with PRA023 compared to CDx+ placebo-treated subjects at Week 12.
    15. The proportion of CDx+ subjects (per alternative algorithm) in clinical remission at week 12.
    1. Percentuale di soggetti con miglioramento endoscopico (definito da un sottopunteggio endoscopico =1 con assenza di friabilità) alla Settimana 12.
    2. Percentuale di soggetti con risposta clinica nel punteggio Mayo modificato a 3 componenti alla Settimana 12. La risposta clinica nel punteggio Mayo modificato a 3 componenti è definita da una riduzione dal Basale =2 punti e =30% nel punteggio Mayo modificato a 3 componenti, accompagnata da una riduzione =1 nel sottopunteggio del sanguinamento rettale o nel sottopunteggio del sanguinamento rettale assoluto =1.
    3. Percentuale di soggetti nella remissione clinica del punteggio Mayo modificato a 3 componenti (definita da un sottopunteggio endoscopico di 0 o 1, sottopunteggio di sanguinamento rettale di 0 e sottopunteggio di frequenza delle feci di 0 o 1 e non superiore al Basale), in soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto ai soggetti trattati con placebo CDx+ alla Settimana 12. Il punteggio Mayo modificato a 3 componenti varia da 0 a 9 e comprende i domini relativi a sanguinamento rettale, frequenza delle feci e valutazione endoscopica.
    4. Percentuale di soggetti con remissione istologica (definita da un punteggio di Geboes =3,1) alla Settimana 12.
    5. Percentuale di soggetti con miglioramento mucosale istologico-endoscopico (definito da un punteggio di Geboes =3,1 e un sottopunteggio endoscopico =1 con assenza di friabilità) alla Settimana 12.
    6. Percentuale di soggetti con miglioramento endoscopico, definito da un sottopunteggio endoscopico =1 con assenza di friabilità, nei soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto ai soggetti CDx+ trattati con placebo alla Settimana 12.
    7. Percentuale di soggetti con risposta clinica nel punteggio Mayo modificato a 3 componenti in soggetti CDx+ trattati con PRA023 rispetto ai soggetti trattati con placebo CDx+ alla Settimana 12. La risposta clinica nel punteggio Mayo modificato a 3 componenti è definita da una riduzione dal Basale =2 punti e =30% nel punteggio Mayo modificato a 3 componenti, accompagnata da una riduzione =1 nel sottopunteggio del sanguinamento rettale o nel sottopunteggio del sanguinamento rettale assoluto =1.
    8. Percentuale di soggetti con remissione istologica, definita da un punteggio di Geboes =3,1, in soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto a soggetti CDx+ trattati con placebo alla Settimana 12.
    9. Percentuale di soggetti con miglioramento mucosale istologico-endoscopico (definito da un punteggio di Geboes =3,1 e un sottopunteggio endoscopico =1 con assenza di friabilità), in soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto ai soggetti trattati con placebo CDx+ alla Settimana 12.
    10. Percentuale di soggetti con remissione clinica (definita da un sottopunteggio endoscopico di 0 o 1, sottopunteggio di sanguinamento rettale di 0 e sottopunteggio di frequenza delle feci di 0 o 1 e non superiore al Basale) in soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto ai soggetti CDx- trattati con PRA023 alla Settimana 12.
    11. Percentuale di soggetti con guarigione mucosale (definita da un punteggio di Geboes =2B.1 e un sottopunteggio endoscopico = 1) alla Settimana 12.
    12. Percentuale di soggetti con guarigione mucosale (definita da un punteggio di Geboes =2B.1 e un sottopunteggio endoscopico =1), in soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto ai soggetti trattati con placebo CDx+ alla Settimana 12.
    13. Percentuale di soggetti con risposta all’IBDQ, definita da un aumento =16 punti rispetto al Basale alla Settimana 12.
    14. La percentuale di soggetti con risposta all’IBDQ, definita da un aumento =16 punti rispetto al basale, nei soggetti CDx+ (Coorte 1 + Coorte 2) trattati con PRA023 rispetto ai soggetti CDx+ trattati con placebo alla Settimana 12.
    15. La percentuale di soggetti in remissione clinica in soggetti CDx+ per algoritmo alternativo alla Settimana 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    Settimana 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Belarus
    Canada
    Georgia
    Israel
    Russian Federation
    Ukraine
    United States
    Belgium
    Bulgaria
    France
    Hungary
    Italy
    Poland
    United Kingdom
    Czechia
    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 years2
    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 years2
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 170
    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)
    After participants have stopped taking study drug, they will undergo 12 weeks of follow-up. The investigator will talk to them about how best to continue their medical care.
    12 settimane di follow up dopo la sospensione del farmaco. Lo sperimentatore informerà come stabilito.
    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 Decision2021-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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