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    Summary
    EudraCT Number:2019-002698-74
    Sponsor's Protocol Code Number:B7541007
    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:2021-06-15
    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 number2019-002698-74
    A.3Full title of the trial
    A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS.
    STUDIO DI FASE 2B, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, DI DOSE-RANGING PER VALUTARE L'EFFICACIA, LA SICUREZZA E LA FARMACOCINETICA DI PF-06480605 NEI PARTECIPANTI DI ETA' ADULTA AFFETTI DA COLITE ULCEROSA DA MODERATA A GRAVE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of PF-06480605 in adult participants with moderate to severe ulcerative colitis.
    Studio per valutare efficacia e sicurezza di PF-06480605 in partecipanti di età adulta con colite ulcerosa da moderata a grave.
    A.3.2Name or abbreviated title of the trial where available
    TUSCANY 2
    TUSCANY 2
    A.4.1Sponsor's protocol code numberB7541007
    A.5.4Other Identifiers
    Name:US IND NumberNumber:129188
    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 SponsorPFIZER 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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post code10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.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 namePF-06480605
    D.3.2Product code [PF-06480605]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPF-06480605
    D.3.9.2Current sponsor codePF-06480605
    D.3.9.4EV Substance CodeSUB181859
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typePF-06480605 neutralizza il legame e il successivo segnale di TL1A al suo recettore funzionale DR3 sulle cellule immunitarie del sistema immunitario innato e adattativo.
    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 injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED DOSE-RANGING STUDY IN ADULT WITH MODERATE TO SEVERE ULCERATIVE COLITIS.
    STUDIO DI FASE 2B, MULTICENTRICO, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO, DI DOSE-RANGING PER VALUTARE L’EFFICACIA, LA SICUREZZA E LA FARMACOCINETICA DI PF-06480605 NEI PARTECIPANTI DI ETÀ ADULTA AFFETTI DA COLITE ULCEROSA DA MODERATA A GRAVE.
    E.1.1.1Medical condition in easily understood language
    Adults with moderate to severe Inflammatory Bowel Disease.
    Adulti affetti da malattia infiammatoria intestinale da moderato a grave.
    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 HLT
    E.1.2Classification code 10009888
    E.1.2Term Colitis (excl infective)
    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
    1. To evaluate the efficacy of PF-06480605 in induction of clinical remission at Week 14 in participants with moderate to severe active UC.

    2. To evaluate the safety and tolerability of PF-06480605 during the induction period (from baseline to Week 14) and during the chronic therapy period (from Week 14 to the End of Study Visit).
    1. Valutare l’efficacia di PF-06480605 nell’induzione della remissione clinica alla 14a settimana nei partecipanti affetti da CU da moderata a grave.

    2. Valutare la sicurezza e la tollerabilità di PF-06480605 durante il periodo di induzione (dal basale alla 14a settimana) e durante il periodo di terapia cronica (dalla 14a settimana alla visita di fine studio).
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of PF-06480605 in inducing remission at Week 14 in participants with moderate to severe active UC.
    2. To evaluate the efficacy of PF-06480605 on endoscopic appearance at Week 14 during the induction period.
    3. To characterize the PK of PF-06480605 during the induction and the chronic therapy periods.
    4. To evaluate disease and pathway related biomarkers (ie, hsCRP and fecal calprotectin and serum sTL1A) during the induction and the chronic therapy periods.
    5. To characterize the immunogenicity of PF-06480605 during the induction and the chronic therapy periods.
    1. Valutare l’efficacia di PF-06480605 nell’indurre la remissione alla 14a settimana in partecipanti affetti da CU da moderata a grave.
    2. Valutare l’efficacia di PF-06480605 sulla comparsa endoscopica alla 14a settimana durante il periodo di induzione.
    3. Caratterizzare il PK di PF-06480605 durante il periodo di induzione e il periodo di terapia cronica.
    4. Valutare i biomarcatori relativi alla malattia e al percorso (ad es., hsCRP, ossia proteina C-reattiva ad alta sensibilità, calprotectina fecale e siero sTL1A) durante il periodo di induzione e il periodo di terapia cronica.
    5. Valutare l’immunogenicità di PF-06480605 durante il periodo di induzione e il periodo di terapia cronica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female participants 18 to 75 years of age.
    2. A diagnosis of UC for >= 3 months with endoscopy and pathology reports supporting the diagnosis, disease duration, and extent of disease.
    3. Moderate to severe active UC as defined by a Total Mayo Score of >=6, and an endoscopic subscore of >=2.
    4. Active disease beyond the rectum (>15 cm from the anal verge).
    5. Failed or be intolerant of at least 1 of the following treatments. Steroids, Immunosuppressants (azathioprine [AZA], 6-mercaptopurine [6-MP] or methotrexate [MTX]), Anti-TNF inhibitors (eg, infliximab, adalimumab, or golimumab), Anti-integrin inhibitors (eg, vedolizumab), Anti-IL-12/23 inhibitors (eg, ustekinumab), JAK inhibitors (eg, tofacitinib).
    Participants currently receiving treatments for UC are eligible providing they have been and are anticipated to be on stable dose for the duration of the study.
    6. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
    7. Body Mass Index (BMI) >=17.5 kg/m2 and body weight >=40kg.
    8. Willing and able to give signed informed consent and comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
    1. Partecipanti maschi o femmine di età da 18 anni fino a 75 anni.
    2. Diagnosi della CU per un periodo >= 3 mesi. I report endoscopici e patologici a sostegno della diagnosi, della durata e dell’estensione della malattia devono essere disponibili nella documentazione originale.
    3. Partecipanti affetti da CU da moderata a grave come definita da un punteggio Mayo totale >=6, e un sottopunteggio endoscopico >=2.
    4. Malattia attiva oltre il retto (>15 cm di malattia attiva dall’estremità anale all’endoscopia di screening).
    5. I partecipanti devono risultare negativi o essere intolleranti ad almeno uno dei seguenti trattamenti per CU: Steroidi; Immunosoppressori (azatioprina [AZA], 6-mercaptopurina [6-MP], o metotrexate [MTX]); Inibitori anti-TNF (ad es., infliximab, adalimumab, o golimumab); Inibitori anti-integrinici (ad es., vedolizumab); Inibitori anti-IL-12/23 (ad es., ustekinumab); Inibitori JAK (ad es., tofacitinib).
    Nota: i partecipanti che attualmente ricevono trattamenti per la CU sono idonei a condizione che siano stati trattati e si prevede che siano trattati con dose stabile per tutta la durata dello studio.
    6. Partecipanti disposti e in grado di rispettare tutte le visite programmate, il piano di trattamento, i test di laboratorio, le considerazioni sullo stile di vita e altre procedure di studio.
    7. Indice di massa corporea (IMC) >=17,5 kg/m2 e peso corporeo >=40 kg.
    8. Capacità di fornire il proprio consenso informato e di rispettare tutte le visite programmate, il piano di trattamento, i test di laboratorio, le considerazioni sullo stile di vita e altre procedure di studio.
    E.4Principal exclusion criteria
    1. Diagnosis of ischemic colitis,infectious colitis,radiation colitis,microscopic colitis,indeterminate colitis or findings suggestive of Crohn's disease
    2. Clinical signs of fulminant colitis or toxic megacolon
    3. Imminent need for surgery or elective surgery scheduled to occur during the study
    4. Evidence of colonic dysplasia,adenomas or neoplasia
    5. Participants who meet either of the 2 criteria below are considered at risk for colonic dysplasia,adenomas,or neoplasia and must have a colonoscopy prior to randomization:
    a. If the participant has had extensive colitis for>=8 yrs or disease limited to left side of colon for>=10 years, regardless of age,a colonoscopy within 1 yr of screening visit is required to survey for dysplasia.
    b. If the participant is>=50 yrs of age,a colonoscopy within 10 yrs of screening is required to exclude adenomatous polyps.
    Participants with adenomatous polyps identified on screening endoscopy will be eligible after complete polypectomy and follow up surveillance
    per local guidelines is negative.
    Or, If the participant is over 50 yrs of age, a colonoscopy within 10 yrs of screening is required to exclude adenomatous polyps
    Participants with adenomatous polyps identified on screening endoscopy will be eligible after complete polypectomy and follow-up surveillance
    per local guidelines is negative
    6. Clinically significant infections within 6 months of baseline or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study
    7. Cancer or history of cancer or lymphoproliferative disease within 5 yrs of baseline (with the exception of adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ)
    8. Other acute or chronic medical or psychiatric condition including recent (within the past yr) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
    9. Use of prohibited medications
    10. Known exposure to anti-TL1A(PF-06480605) or any type of anti-TL1A therapy
    11. Previous administration with an investigational drug within 30 days(or as determined by the local requirement)or 5 half lives preceding the
    first dose of investigational product used in this study (whichever is longer)
    12. A 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
    13. Chest Radiograph showing abnormalities
    14. Infected with tuberculosis: Any evidence of untreated latent or active TB infection
    15. Presence of active enteric infections:Known pathogenic bacterial,parasitic,fungal infections,including Clostridium difficile
    16. Infected with human immunodeficiency virus,(HIV),Hepatitis B or C viruses.
    17. Participants with ANY of the following abnormalities in clinical laboratory tests at screening,as assessed by the study specific laboratory and confirmed by a single repeat,if deemed necessary:
    • Hemoglobin<8.0 g/dL or hematocrit<30%(<0.30 v/v);
    • Absolute lymphocyte count(ALC)<0.8x109/L(<1000/mm3);
    • Absolute neutrophil count(ANC)<1.2x109/L(<1500/mm3);
    • Platelet count<100x109/L(<100,000/mm3);
    • Aspartate aminotransferase(AST) or alanine aminotransferase(ALT)>=2.0 times the upper limit of normal(ULN);
    • Total bilirubin level>=1.5 times the ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be
    eligible for this study provided the direct bilirubin in<=ULN
    18. History of alcohol or drug abuse that would prevent the participant from being compliant with study visits and required procedures
    19. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise
    supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study
    1.Diagnosi di colite ischemica,colite infettiva,colite da radiazioni,colite microscopica,colite indeterminata o con risultati medici indicativi della malattia di Crohn
    2.Segni clinici di colite fulminante o megacolon tossico
    3.Imminente necessità di un intervento chirurgico o prevista chirurgia elettiva durante il corso dello studio
    4.Evidenza di displasia del colon, adenomi o neoplasia
    5.I partecipanti che soddisfano uno dei due criteri seguenti sono considerati a rischio di displasia del colon, adenomi o neoplasia e devono effettuare una colonscopia prima della randomizzazione:
    a.Se il partecipante ha sofferto di una colite estesa per un periodo>=8 anni o di una malattia limitata al lato sinistro del colon per un periodo>=10 anni, indipendentemente dall’età, è necessaria una colonscopia entro 1 anno dalla visita di screening per rilevare la displasia
    b.Se il partecipante ha un’età>=50 anni è necessaria una colonscopia entro 10 anni dallo screening per escludere i polipi adenomatosi. I partecipanti con polipi adenomatosi identificati nell’endoscopia di screening saranno idonei una volta effettuata una polipectomia completa e quando le successive attività di controllo risultino negative secondo le linee guida locali
    6.Soggetti con infezioni clinicamente significative entro 6 mesi dal basale o con altre infezioni altrimenti ritenute dallo sperimentatore potenzialmente in grado di aggravarsi a causa della partecipazione allo studio
    7.Cancro o anamnesi di cancro o malattia linfoproliferativa entro 5 anni dal basale (ad eccezione dei partecipanti con carcinoma basale non metastatico o squamoso della pelle o del carcinoma cervicale in situ, adeguatamente trattato o asportato)
    8.Altre condizioni psichiatriche o mediche croniche o acute compresi, siano essi recenti o attivi, idee o comportamenti suicidi o un’anomalia di laboratorio in grado di aumentare il rischio associato alla partecipazione allo studio o di interferire con l’interpretazione dei risultati dello studio
    9.Terapia precedente/concomitante con farmaci proibiti
    10.Esposizione nota all’anti-TL1A(PF-06480605) o a qualsiasi tipo di terapia anti-TL1A
    11.Precedente somministrazione di un farmaco sperimentale entro 30 giorni (o come previsto dai requisiti locali) o 5 emivite precedenti la prima dose del prodotto sperimentale utilizzato nel presente studio (a seconda di quale sia il periodo più lungo)
    12.Un ECG a 12 derivazioni che dimostri anomalie clinicamente rilevanti che possano influire sulla sicurezza dei partecipanti o sull’interpretazione dei risultati dello studio
    13.RX del torace che mostri anomalie
    14.Infezione da tubercolosi (TB): qualsiasi prova di infezione da TB latente o attiva non trattata
    15.Infezioni enteriche attive:infezioni batteriche, parassitarie e fungine note tra cui Clostridium difficile
    16.Infezioni da virus dell’immunodeficienza umana(HIV) e virus dell’epatite B o C.
    17.Partecipanti con UNA QUALSIASI delle seguenti anomalie nei test di laboratorio clinici allo screening, valutati dal laboratorio specifico dello studio e confermati con una singola ripetizione,se ritenuto necessario:
    •Hb<8,0g/dl o HCT<30%(<0,30v/v);
    •ALC<0,8x109/l(<1000/mm3);
    •ANC<1,2x109/l(<1500 mm3);
    •PLT<100x109/l(<100,000/mm3);
    •AST o ALT=>2,0 volte il limite superiore della norma (ULN);
    •Livello di bilirubina totale>=1,5 volte l’ULN; i partecipanti con una storia di sindrome di Gilbert possono essere sottoposti alla misurazione della bilirubina diretta e sono idonei per questo studio a condizione che la bilirubina diretta sia<= ULN;
    18.Storia di abuso di alcol o stupefacenti che impedirebbe al partecipante di essere conforme alle visite di studio e alle procedure richieste.
    19.Membri del personale del centro dello sperimentatore direttamente coinvolti nella conduzione dello studio e i loro familiari, membri del personale del centro altrimenti supervisionati dallo sperimentatore o dipendenti Pfizer, compresi i loro familiari, direttamente coinvolti nella conduzione dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants achieving clinical remission (defined as a Total Mayo Score <=2, with no individual subscore >1) at Week 14.
    Incidence and severity of treatment emergent adverse events (TEAEs) during the induction period.
    Incidence of serious adverse events (SAEs).
    Incidence of AEs or SAEs leading to discontinuation.
    Incidence of clinically significant abnormalities in vital signs, ECGs and laboratory values.
    Percentuale di partecipanti che raggiungono la remissione clinica (definita come Mayo Score totale <=2, senza sottopunteggio individuale >1) alla settimana 14.
    Incidenza e gravità degli eventi avversi emergenti (TEAE) durante il periodo di induzione.
    Incidenza di eventi avversi gravi (SAE).
    Incidenza di eventi avversi (AEs) o di eventi avversi gravi (SAE) che hanno portato all'interruzione del trattamento.
    Incidenza di anomalie clinicamente significative nei segni vitali, elettrocardiogrammi e valori di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At weeks 14 and 56 unless otherwise specified above.
    Alla settimana 14 e 56, a meno che non diversamente specificato sopra.
    E.5.2Secondary end point(s)
    Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 14.
    Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, >=1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 14.
    Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 14.
    Proportion of participants achieving endoscopic remission (defined as endoscopic subscore = 0) at Week 14.
    PF 06480605 trough concentrations during the induction period through Week 14.
    Change from baseline in fecal calprotectin during the induction period through Week 14.
    Change from baseline in hsCRP during the induction period through Week 14.
    Change from baseline in serum sTL1A during the induction period through Week 14.
    Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) during the induction period through Week 14.
    Proportion of participants achieving clinical remission (defined as a Total Mayo Score of 2, with no individual subscore >1) at Week 56.
    Proportion of participants achieving sustained clinical remission (ie, clinical remission at both Week 14 and Week 56).
    Proportion of participants achieving remission (FDA definition 1 - defined as endoscopic subscore = 0 or 1, stool frequency subscore = 0, and rectal bleeding subscore = 0) at Week 56.
    Proportion of participants achieving sustained remission FDA definition 1 (ie, remission FDA definition 1 at both Week 14 and Week 56).
    Proportion of participants achieving remission (FDA definition 2 - defined as endoscopic subscore = 0 or 1, >=1 point decrease from baseline to achieve a stool frequency subscore = 0 or 1, and rectal bleeding subscore = 0) at Week 56.
    Proportion of participants achieving sustained remission FDA definition 2 (ie, remission FDA definition 2 at both Week 14 and Week 56).
    Proportion of participants achieving endoscopic improvement (defined as endoscopic subscore = 0 or 1) at Week 56.
    Proportion of participants achieving sustained endoscopic improvement (ie, endoscopic improvement at both Week 14 and Week 56).
    Proportion of participants achieving endoscopic remission (defined as endoscopic sub score = 0) at Week 56.
    Proportion of participants achieving sustained endoscopic remission (ie, endoscopic remission at both Week 14 and Week 56).
    PF-06480605 concentration from Week 14 through the End of Study Visit.
    Change from Week 14 in fecal calprotectin during the chronic therapy period through the End of Study Visit.
    Change from Week 14 in hsCRP during the chronic therapy period through the End of Study Visit.
    Change from week 14 in serum sTL1A during the chronic therapy period through the End of Study Visit.
    Incidence of development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) from Week 14 through the End of Study Visit.
    Percentuale dei partecipanti che raggiungono la remissione Food and Drug Administration, (definizione (FDA) 1 - definita come sottopunteggio endoscopico = 0 o 1, sottopunteggio frequenza feci = 0, e sottopunteggio sanguinamento rettale = 0) alla settimana 14.
    Percentuale di partecipanti che raggiungono la remissione (definizione FDA 2 - definita come sottopunteggio endoscopico = 0 o 1, =1 punto di diminuzione dal basale per ottenere un sottopunteggio frequenza feci = 0 o 1, e sottopunteggio sanguinamento rettale = 0) alla settimana 14.
    Percentuale di partecipanti che ottengono un miglioramento endoscopico (definito come sottopunteggio endoscopico = 0 o 1) alla settimana 14.
    Percentuale di partecipanti che raggiungono la remissione endoscopica (definita come sottopunteggio endoscopico = 0) alla settimana 14.
    PF-06480605 con concentrazioni minime durante il periodo di induzione fino alla settimana 14.
    Cambiamento dal basale della calprotectina fecale durante il periodo di induzione fino alla settimana 14.
    Cambiamento dal basale nella proteina hsCRP durante il periodo di induzione fino alla settimana 14.
    Cambiamento dal basale nel siero sTL1A durante il periodo di induzione fino alla settimana 14.
    Incidenza dello sviluppo di anticorpi anti farmaco (anti-drug antibodies, ADA) e anticorpi neutralizzanti (neutralizing antibodies, NAb) durante il periodo di induzione fino alla settimana 14.
    Percentuale di partecipanti che raggiungono la remissione clinica (definita come Mayo Score totale <=2, senza sottopunteggio individuale >1) alla settimana 56.
    Percentuale di partecipanti che ottengono una remissione clinica sostenuta (ossia, remissione clinica sia alla settimana 14 che alla settimana 56).
    Percentuale di partecipanti che raggiungono la remissione (definizione FDA 1 definita come sottopunteggio endoscopico = 0 o 1, sottopunteggio frequenza feci = 0, e sottopunteggio sanguinamento rettale = 0) alla settimana 56.
    Percentuale di partecipanti che raggiungono una remissione sostenuta definizione FDA 1 (ossia, remissione definizione FDA 1 sia alla settimana 14 che alla settimana 56).
    Percentuale di partecipanti che raggiungono la remissione (definizione FDA 2 - definita come sottopunteggio endoscopico = 0 o 1, >=1 punto di diminuzione dal basale per ottenere un sottopunteggio frequenza feci = 0 o 1, e sottopunteggio sanguinamento rettale = 0) alla settimana 56.
    Percentuale di partecipanti che ottengono una remissione sostenuta definizione FDA 2 (ossia, remissione definizione FDA 2 sia alla settimana 14 che alla settimana 56).
    Percentuale di partecipanti che ottengono un miglioramento endoscopico (definito come sottopunteggio endoscopico = 0 o 1) alla settimana 56.
    Percentuale dei partecipanti che ottengono un miglioramento endoscopico sostenuto (ossia, miglioramento endoscopico sia alla settimana 14 che alla settimana 56).
    Percentuale di partecipanti che raggiungono la remissione endoscopica (definita come sottopunteggio endoscopico = 0) alla settimana 56.
    Percentuale dei partecipanti che ottengono una remissione endoscopica sostenuta (ossia, remissione endoscopica sia alla settimana 14 che alla settimana 56).
    Concentrazione di PF-06480605 dalla settimana 14 fino alla visita finale dello studio.
    Cambiamento dalla settimana 14 nella calprotectina fecale durante il periodo di terapia cronica fino alla visita di fine studio.
    Cambiamento dalla settimana 14 nella proteina C-reattiva ad alta sensibilità (shCRP) durante il periodo di terapia cronica fino alla visita di fine studio.
    Cambiamento dalla settimana 14 nel siero sTL1A durante il periodo di terapia cronica fino alla visita di fine studio.
    Incidenza dello sviluppo di anticorpi anti-farmaco (ADA) e anticorpi neutralizzanti (NAb) dalla settimana 14 fino alla visita di fine studio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Individual timepoints as detailed above for each endpoint.
    Tempistiche individuali come definito sopra per ciascun endpoint.
    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 Yes
    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 No
    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 trial9
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Canada
    China
    India
    Israel
    Japan
    Mexico
    Russian Federation
    Serbia
    Turkey
    Ukraine
    United States
    Belgium
    Bulgaria
    France
    Italy
    Poland
    Romania
    Slovakia
    Spain
    Czechia
    E.8.7Trial has a data monitoring committee No
    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
    A participant is considered to have completed the study if he/she has completed all phases of the study including: screening, induction phase, chronic therapy period, and the follow up portion of the study up through and including visit (Visit 18), approximately 12 weeks post last dose of IP.
    The end of the study is defined as the date of the last visit (Visit 18), by the last participant across all sites globally.
    Un partecipante completa lo studio se giunge al termine di ciascuna sua fase, inclusi: lo screening, la fase di induzione, il periodo di terapia cronica e la parte di follow-up fino alla visita (18a Visita), all'incirca 12 settimane dopo la somministrazione dell'ultima dose di IP.
    Lo studio si considera concluso il giorno dell'ultima visita (18a Visita) dell'ultimo partecipante di tutti i centri, a livello globale.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days16
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 240
    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)
    No intervention will be provided to study participants at the end of the study.
    Al termine dello studio non è previsto alcun intervento per i partecipanti.
    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 Decision2020-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-26
    P. End of Trial
    P.End of Trial StatusOngoing
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