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    Summary
    EudraCT Number:2020-004775-40
    Sponsor's Protocol Code Number:APD334-202EU
    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:2022-01-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004775-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease
    Studio multicentrico, randomizzato, in doppio cieco, a gruppi paralleli per valutare l’efficacia e la sicurezza di etrasimod orale come terapia di induzione e mantenimento per la malattia di Crohn da moderatamente a gravemente attiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Crohn's Disease
    Studio che valuta l'efficacia e la sicurezza di Etrasimod nel trattamento di pazienti con malattia di Crohn da moderatamente a gravemente attiva
    A.3.2Name or abbreviated title of the trial where available
    CULTIVATE
    CULTIVATE
    A.4.1Sponsor's protocol code numberAPD334-202EU
    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 SponsorARENA PHARMACEUTICALS, 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 supportArena Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointTracy Angelly
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego - CA
    B.5.3.3Post code92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018582104524
    B.5.6E-mailtangelly@arenapharm.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 nameEtrasimod
    D.3.2Product code [APD334]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 nameEtrasimod
    D.3.2Product code [APD334]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNetrasimod L-arginine
    D.3.9.1CAS number 1206123-97-8
    D.3.9.2Current sponsor codeAPD334 L-arginine
    D.3.9.4EV Substance CodeSUB171412
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboTablet
    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
    Crohn's Disease
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease a form of inflammatory bowel disease.
    Malattia di Crohn, una forma di malattia infiammatoria intestinale
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Substudy A - Phase 2 (SSA-P2) (optional)
    •To evaluate the safety, tolerability, and efficacy of 2 doses of etrasimod as induction therapy in subjects with moderately to severely active Crohn's disease (CD)
    Substudy 1 - Phase 2b - (SS1-P2b)
    • To evaluate the dose-response relationship of 2 doses of etrasimod vs placebo as induction therapy in subjects with moderately to severely active CD
    • To select an oral etrasimod dose(s), based on efficacy and safety for continued development
    Substudy 2 – Induction (Phase 3) (SS2-I)
    • To evaluate the efficacy of the selected etrasimod dose vs placebo as induction therapy in subjects with moderately to severely active CD
    Substudy 3 – Maintenance (Phase 3) (SS3-M)
    • To evaluate the efficacy of etrasimod vs placebo as maintenance therapy in subjects with moderately to severely active CD
    Substudy 4 – Long-Term Extension (SS4-E)
    • To evaluate the long-term safety and tolerability of etrasimod in subjects with moderately to severely active CD
    Sottostudio A - Fase 2 (SSA-P2) (opzionale)
    •Valutare la sicurezza, la tollerabilità e l'efficacia di 2 dosi di etrasimod come terapia di induzione in soggetti con malattia di Crohn (MC) da moderatamente a gravemente attiva
    Sottostudio 1 - Fase 2b - (SS1-P2b)
    • Valutare la relazione dose-risposta di 2 dosi di etrasimod vs placebo come terapia di induzione in soggetti con MC da moderatamente a gravemente attiva
    • Selezionare una o più dosi di etrasimod per via orale, in base all'efficacia e alla sicurezza per lo sviluppo continuo
    Sottostudio 2 – Induzione (Fase 3) (SS2-I)
    • Valutare l'efficacia della dose selezionata di etrasimod rispetto al placebo come terapia di induzione in soggetti con MC da moderatamente a gravemente attiva
    Sottostudio 3 – Manutenzione (Fase 3) (SS3-M)
    • Valutare l'efficacia di etrasimod rispetto al placebo come terapia di mantenimento in soggetti con MC da moderatamente a gravemente attiva
    Sottostudio 4 – Estensione a lungo termine (SS4-E)
    • Valutare la...
    E.2.2Secondary objectives of the trial
    SSA (optional)
    long-term safety, tolerability & efficacy of etrasimod in subjects with moderately to severely active CD
    PK effects of etrasimod as induction & maintenance therapy in subjects with moderately to severely active CD
    SS1
    Long-Term safety, tolerability & efficacy of etrasimod in subjects with moderately to severely active CD
    SS2
    safety & tolerability of selected etrasimod Ph3 dose vs placebo as induction therapy in subjects with moderately to severely active CD
    SS3
    efficacy of etrasimod on sustained clinical remission & endoscopic response, endoscopic remission & corticosteroid-free clinical remission in subjects with moderately to severely active CD characterize safety & tolerability of etrasimod as maintenance therapy in subjects with moderately to severely active CD
    SS4
    Long-Term efficacy of etrasimod in subjects with moderately to severely active CD
    SSA (opzionale)
    Sicurezza, tollerabilità ed efficacia a lungo termine di etrasimod in soggetti con MC da moderatamente a gravemente attiva
    Effetti farmacocinetici di etrasimod come terapia di induzione e mantenimento in soggetti con MC da moderatamente a gravemente attiva
    SS1
    Sicurezza, tollerabilità ed efficacia a lungo termine di etrasimod in soggetti con MC da moderatamente a gravemente attiva
    SS2
    Sicurezza e tollerabilità della dose selezionata della fase 3di etrasimod rispetto al placebo come terapia di induzione in soggetti con MC da moderatamente a gravemente attiva
    SS3
    Efficacia di etrasimod su remissione clinica sostenuta e risposta endoscopica, remissione endoscopica e remissione clinica senza corticosteroidi in soggetti con MC da moderatamente a gravemente attiva, caratterizzare la sicurezza e tollerabilità di etrasimod come terapia di mantenimento in soggetti con MC da moderatamente a gravemente attiva
    SS4
    Efficacia a lungo termine di etrasimod in soggetti con...
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects 18 to 80 years of age, inclusive, at the time of consent
    2. Ability to provide written informed consent and to be compliant with the schedules of protocol assessments
    3. Have CD for = 3 months prior to randomization, involving the ileum and/or colon, at a minimum; diagnosis may be confirmed at any time in the past by endoscopy and histopathology. The screening endoscopy and histopathology reports may serve as source documents for subjects who do not have diagnostic endoscopy reports in their medical chart
    4. Have moderately to severely active CD at Screening, defined as:
    - Crohn's Disease Activity Index (CDAI) score = 220 and = 450, AND
    - Unweighted average worst daily abdominal pain (AP) score = 2 unweighted average daily loose/watery stool frequency (SF) score = 4,
    AND
    - Simple Endoscopic Score in Crohn's disease (SES-CD) of = 6 or SES-CD = 4 for subjects with isolated ileal disease
    5. Demonstrated inadequate response, loss of response to, or intolerance to = 1 of the following therapies for the treatment of CD
    - Oral corticosteroids (eg, prednisone [or its equivalent] or budesonide)
    - Immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate)
    - Tumor necrosis factor alpha (TNFa) antagonists (eg, infliximab, adalimumab, certolizumab pegol, or biosimilars)
    - Integrin receptor antagonist (eg, vedolizumab)
    - Interleukin-12/-23 antagonist (eg, ustekinumab)
    6. Females of childbearing potential must be nonpregnant
    7. Females must meet either a or b of the following criteria and males must meet criterion c to qualify for the study:
    a. A female who is not of childbearing potential must meet 1 of the following:
    - Postmenopausal, defined as no menses for 12 months without an alternative medical cause and confirmed by follicle-stimulating hormone (FSH) within postmenopausal range according to local standards
    - Permanent sterilization procedure, such as hysterectomy, bilateral salpingectomy, or bilateral oophorectomy
    b. A female who is of childbearing potential must agree to using a highly effective contraception method during treatment and for 4 weeks following treatment that can achieve a failure rate of less than 1% per year when used consistently and correctly.
    The following are considered highly effective birth control methods:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation, which may be oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomized partner, provided that partner is the sole sexual partner of the FOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success
    - Sexual abstinence (complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study drug). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable
    c. A male must agree to using condoms during treatment and for 4 weeks following treatment
    SS3-M, SS4-E: Females and males must continue to meet contraception criterion described above
    1. Soggetti di età compresa tra 18 e 80 anni, compresi, al momento del consenso
    2. Capacità di fornire il consenso informato scritto e di essere conforme ai programmi di valutazione del protocollo
    3. Avere MC per = 3 mesi prima della randomizzazione, coinvolgendo come minimo l'ileo e/o il colon; la diagnosi può essere confermata in qualsiasi momento in passato dall'endoscopia e dall'istopatologia. I referti di screening endoscopico e istopatologico possono servire come documenti di partenza per i soggetti che non hanno referti di endoscopia diagnostica nella cartella clinica
    4. Avere MC da moderatamente a gravemente attiva allo Screening, definita come:
    - Punteggio dell'indice di attività della malattia di Crohn (CDAI) = 220 e = 450, E
    - Punteggio medio non ponderato del dolore addominale peggiore giornaliero (AP) = punteggio 2 medio non ponderato della frequenza di feci molli/acquose giornaliere (SF) = 4
    E
    - Simple Endoscopic Score nella malattia di Crohn (SES-CD) di = 6 o SES-CD = 4 per i soggetti con malattia ileale isolata
    5. Dimostrata risposta inadeguata, perdita di risposta o intolleranza a = 1 delle seguenti terapie per il trattamento della MC
    - Corticosteroidi orali (p. es., prednisone [o equivalente] o budesonide)
    - Immunosoppressori (p. es., azatioprina, 6-mercaptopurina o metotrexato)
    - Antagonisti del fattore di necrosi tumorale alfa (TNFa) (p. es., infliximab, adalimumab, certolizumab pegol o biosimilari)
    - Antagonista del recettore dell'integrina (ad es. vedolizumab)
    - Antagonista dell'interleuchina-12/-23 (ad es. ustekinumab)
    6. Le donne in età fertile devono essere non gravide
    7. Le donne devono soddisfare a o b dei seguenti criteri e gli uomini devono soddisfare il criterio c per qualificarsi per lo studio:
    a. Una donna che non è in età fertile deve soddisfare 1 dei seguenti requisiti:
    - Postmenopausa, definita come assenza di mestruazioni per 12 mesi senza una causa medica alternativa e confermata dall'ormone follicolo-stimolante (FSH) nell'intervallo postmenopausale secondo gli standard locali
    - Procedura di sterilizzazione permanente, come isterectomia, salpingectomia bilaterale o ovariectomia bilaterale
    b. Una donna in età fertile deve accettare di utilizzare un metodo contraccettivo altamente efficace durante il trattamento e per 4 settimane dopo il trattamento che può raggiungere un tasso di fallimento inferiore all'1% all'anno se usato in modo coerente e corretto.
    I seguenti sono considerati metodi contraccettivi altamente efficaci:
    - Contraccezione ormonale combinata (contenente estrogeni e progestinici) associata all'inibizione dell'ovulazione, che può essere orale, intravaginale o transdermica
    - Contraccezione ormonale a base di solo progestinico associata all'inibizione dell'ovulazione, che può essere orale, iniettata o impiantata
    - Dispositivo intrauterino (IUD)
    - Sistema intrauterino di rilascio dell'ormone (IUS)
    - Occlusione tubarica bilaterale
    - Partner vasectomizzato, a condizione che il partner sia l'unico partner sessuale del partecipante allo studio FOCBP e che il partner vasectomizzato abbia ricevuto una valutazione medica del successo chirurgico
    - Astinenza sessuale (astinenza sessuale completa definita come l'astensione da rapporti eterosessuali per l'intero periodo di rischio associato al farmaco in studio). L'attendibilità dell'astinenza sessuale deve essere valutata in relazione alla durata dello studio clinico e allo stile di vita preferito e abituale del soggetto. L'astinenza periodica (metodo calendario, sintotermico, post-ovulazione) non è accettabile not
    c. Un uomo deve accettare di usare il preservativo durante il trattamento e per 4 settimane dopo il trattamento
    SS3-M, SS4-E: donne e uomini devono continuare a soddisfare i criteri di contraccezione descritti sopra
    E.4Principal exclusion criteria
    Key exclusion criteria:
    - History of inadequate response (ie, primary non-response) to agents from = 2 classes of biologics marketed for the treatment of CD (ie, TNFa antagonists, interleukin-12/-23 antagonist, and integrin receptor antagonist)
    - Have ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, diverticular disease-associated colitis, toxic megacolon, or active infectious colitis or test positive for Clostridioides difficile toxin at Screening
    - Have functional or post-operative short-bowel syndrome (ie, have > 3 small bowel resections) or any associated complications that may require surgery or interfere with efficacy assessments
    - Had surgical treatment for intra-abdominal abscesses = 8 weeks prior to randomization or surgical treatment for perianal abscesses = 4 weeks prior to randomization
    - Had intestinal resection = 24 weeks prior to randomization or other intra-abdominal surgeries = 12 weeks prior to randomization. Subjects who have undergone previous colonic resection or ileocolectomy must have > 25 cm of colon remaining
    - Have an ileostomy or a colostomy
    - Have a serious infection requiring intravenous antibiotic(s)/medication(s) = 4 weeks prior to randomization
    - Have primary or secondary immunodeficiency syndromes, history of organ transplant, history of an opportunistic infection, history of disseminated herpes simplex or herpes zoster, have or test positive for HIV, HBV, or active HCV
    - Lactating female who is breastfeeding
    Principali criteri di esclusione:
    - Storia di risposta inadeguata (cioè, mancata risposta primaria) ad agenti di = 2 classi di farmaci biologici commercializzati per il trattamento della MC (cioè, antagonisti del TNFa, antagonista dell'interleuchina-12/-23 e antagonista del recettore dell'integrina)
    - Avere colite ulcerosa, colite indeterminata, colite microscopica, colite ischemica, colite da radiazioni, colite associata a malattia diverticolare, megacolon tossico o colite infettiva attiva o test positivo per la tossina di Clostridioides difficile allo screening
    - Avere la sindrome dell'intestino corto funzionale o postoperatorio (cioè avere > 3 resezioni dell'intestino tenue) o qualsiasi complicazione associata che può richiedere un intervento chirurgico o interferire con le valutazioni di efficacia
    - Ha subito un trattamento chirurgico per ascessi intra-addominali = 8 settimane prima della randomizzazione o trattamento chirurgico per ascessi perianali = 4 settimane prima della randomizzazione
    - Aveva resezione intestinale = 24 settimane prima della randomizzazione o altri interventi chirurgici intra-addominali = 12 settimane prima della randomizzazione. I soggetti che hanno subito una precedente resezione del colon o ileocolectomia devono avere > 25 cm di colon rimanenti
    - Avere un'ileostomia o una colostomia
    - Avere un'infezione grave che richiede antibiotici/farmaci per via endovenosa = 4 settimane prima della randomizzazione
    - Avere sindromi da immunodeficienza primaria o secondaria, storia di trapianto di organi, storia di un'infezione opportunistica, storia di herpes simplex disseminato o herpes zoster, avere o risultare positivo per HIV, HBV o HCV attivo
    - Donna in allattamento che sta allattando
    E.5 End points
    E.5.1Primary end point(s)
    SSA-P2
    Portion of subjects with endoscopic response
    SS1-P2b
    Proportion of subjects with endoscopic response at Week 14
    SS2-I
    Proportion of subjects with endoscopic response at Week 14
    Proportion of subjects with clinical remission CDAI at Week 14
    SS3-M
    Proportion of subjects with clinical remission CDAI at Week 52
    Proportion of subjects with endoscopic response at Week 52
    SSA-P2
    Porzione di soggetti con risposta endoscopica
    SS1-P2b
    Percentuale di soggetti con risposta endoscopica alla settimana 14
    SS2-I
    Percentuale di soggetti con risposta endoscopica alla settimana 14
    Percentuale di soggetti con CDAI di remissione clinica alla settimana 14
    SS3-M
    Percentuale di soggetti con CDAI di remissione clinica alla settimana 52
    Percentuale di soggetti con risposta endoscopica alla settimana 52
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14 (SSA-P2, SS1-P2b, SS2-I)
    Week 52 (SS3-M)
    Week 66 (SSA-P2)
    Settimana 14 (SSA-P2, SS1-P2b, SS2-I)
    Settimana 52 (SS3-M)
    Settimana 66 (SSA-P2)
    E.5.2Secondary end point(s)
    SSA-P2:
    Proportion of subjects with clinical remission CDAI
    Change from baseline in SES-CD score
    Change from baseline in CDAI score
    SS1-P2b:
    Proportion of subjects with clinical remission CDAI at Week 14
    SS2-I:
    • Proportion of subjects with clinical remission PRO2 at Week 14
    • Proportion of subjects with clinical response CDAI at Week 14
    • Proportion of subjects with endoscopic response and clinical remission CDAI at Week 14
    • Proportion of subjects with endoscopic remission at Week 14
    SS3-M
    • Proportion of subjects with clinical remission CDAI at Week 52 among subjects in clinical remission CDAI at SS3-M baseline (defined as Week 14 or EI-Week 6 Visit)
    • Proportion of subjects with endoscopic response at Week 52 among subjects in endoscopic response at SS3-M baseline
    • Proportion of subjects with corticosteroid-free clinical remission CDAI at Week 52 among subjects receiving corticosteroids at SS3-M baseline
    • Proportion of subjects with endoscopic remission at Week 52
    • Proportion of subjects with clinical remission PRO2 at Week 52
    SS4-E
    • Proportion of subjects with clinical remission CDAI by visit up to the end of treatment
    • Proportion of subjects with clinical remission PRO2 by visit up to the end of treatment; SSA-P2:
    Percentuale di soggetti con remissione clinica CDAI
    Variazione rispetto al basale nel punteggio SES-CD
    Variazione rispetto al basale nel punteggio CDAI
    SS1-P2b:
    Percentuale di soggetti con CDAI di remissione clinica alla settimana 14
    SS2-I:
    • Percentuale di soggetti con remissione clinica PRO2 alla settimana 14
    • Percentuale di soggetti con risposta clinica CDAI alla Settimana 14
    • Percentuale di soggetti con risposta endoscopica e remissione clinica CDAI alla Settimana 14
    • Percentuale di soggetti con remissione endoscopica alla Settimana 14
    SS3-M
    • Percentuale di soggetti con CDAI di remissione clinica alla settimana 52 tra i soggetti con CDAI di remissione clinica al basale SS3-M (definito come visita alla settimana 14 o EI alla settimana 6)
    • Percentuale di soggetti con risposta endoscopica alla settimana 52 tra i soggetti con risposta endoscopica al basale SS3-M
    • Percentuale di soggetti con CDAI di remissione clinica senza corticosteroidi alla settimana 52 tra i soggetti che hanno ricevuto corticosteroidi al basale SS3-M
    • Percentuale di soggetti con remissione endoscopica alla settimana 52
    • Percentuale di soggetti con remissione clinica PRO2 alla settimana 52
    SS4-Mi
    • Percentuale di soggetti con remissione clinica CDAI per visita fino alla fine del trattamento
    • Percentuale di soggetti con remissione clinica PRO2 per visita fino alla fine del trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 14 (SS1-P2b, SS2-I)
    Week 52 (SS3-M)
    Week 66 (SSA-P2)
    Week 274 (SS4-E); Settimana 14 (SS1-P2b, SS2-I)
    Settimana 52 (SS3-M)
    Settimana 66 (SSA-P2)
    Settimana 274 (SS4-E)
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    dose finding
    determinazione della dose
    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) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    seamless Fase 2/3
    seamless Ph2/3
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA273
    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
    Argentina
    Australia
    Austria
    Belarus
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czechia
    Denmark
    Egypt
    France
    Georgia
    Germany
    Greece
    Hungary
    India
    Ireland
    Israel
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Malaysia
    Mexico
    Moldova, Republic of
    Netherlands
    Norway
    Peru
    Philippines
    Poland
    Portugal
    Puerto Rico
    Romania
    Russian Federation
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Thailand
    Turkey
    Ukraine
    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 years9
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months7
    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: 1107
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 158
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 658
    F.4.2.2In the whole clinical trial 1265
    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
    Nessuno
    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 Decision2021-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-15
    P. End of Trial
    P.End of Trial StatusOngoing
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