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    Summary
    EudraCT Number:2020-003123-42
    Sponsor's Protocol Code Number:INCB39110-213
    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:2021-06-08
    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 number2020-003123-42
    A.3Full title of the trial
    A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post–Polycythemia Vera Myelofibrosis or Post–Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapys
    Studio in aperto di fase 2, in 2 parti, sulla sicurezza, la tollerabilità e l’efficacia di itacitinib a rilascio immediato in pazienti affetti da mielofibrosi primaria o mielofibrosi secondaria (mielofibrosi post-policitemia vera o mielofibrosi post-trombocitemia essenziale) che hanno ricevuto precedente monoterapia con ruxolitinib e/o fedratinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study evaluating safety, tolerability and efficacy of Itacitinib in participants with primary or secondary Myelofibrosis
    Uno studio che valuta la sicurezza, la tollerabilità e l'efficacia di Itacitinib in partecipanti con mielofibrosi primaria o secondaria
    A.3.2Name or abbreviated title of the trial where available
    INCB39110-213
    INCB39110-213
    A.4.1Sponsor's protocol code numberINCB39110-213
    A.5.4Other Identifiers
    Name:IND NumberNumber:113,428
    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 SponsorINCYTE CORPORATION
    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 supportIncyte Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIncyte Corporation
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1801 Augustine Cut-Off
    B.5.3.2Town/ cityWilmington
    B.5.3.3Post codeDE 19803
    B.5.3.4CountryUnited States
    B.5.4Telephone number0013024985670
    B.5.5Fax number0013024252734
    B.5.6E-mailRA@incyte.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1964
    D.3 Description of the IMP
    D.3.1Product nameItacitinib
    D.3.2Product code [INCB039110]
    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 INNItacitinib
    D.3.9.1CAS number 1334298-90-6
    D.3.9.2Current sponsor codeINCB039110
    D.3.9.3Other descriptive nameITACITINIB
    D.3.9.4EV Substance CodeSUB184194
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1964
    D.3 Description of the IMP
    D.3.1Product nameItacitinib
    D.3.2Product code [INCB039110]
    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 INNItacitinib
    D.3.9.1CAS number 1334298-90-6
    D.3.9.2Current sponsor codeINCB039110
    D.3.9.3Other descriptive nameITACITINIB
    D.3.9.4EV Substance CodeSUB184194
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Myelofibrosis or Secondary Myelofibrosis
    Mielofibrosi primaria o mielofibrosi secondaria
    E.1.1.1Medical condition in easily understood language
    Primary Myelofibrosis or Secondary Myelofibrosis
    Mielofibrosi primaria o mielofibrosi secondaria
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: To evaluate the safety and tolerability of itacitinib IR and select the RP2D for Part 2 of the study.
    Part 2: To evaluate the efficacy of itacitinib IR at the RP2D with respect to spleen volume reduction at Week 24.
    Parte 1: valutare la sicurezza e la tollerabilità di itacitinib IR (Immediate Release, rilascio immediato) e selezionare la RP2D (Recommended Phase 2 Dosage, dose raccomandata per la fase 2) per la parte 2 dello studio.
    Parte 2: valutare l’efficacia di itacitinib IR alla RP2D per quanto riguarda la riduzione del volume della milza alla settimana 24.
    E.2.2Secondary objectives of the trial
    Part 2:
    - To evaluate the safety and tolerability of itacitinib IR at the RP2D.
    - To evaluate the efficacy of itacitinib IR at the RP2D with respect to MF symptom improvement at Week 24, in those patients with a baseline TSS= 10.
    - To evaluate the efficacy of itacitinib IR with respect to improvement of quality of life.
    - To evaluate the efficacy of itacitinib IR at the RP2D with respect to PGIC.
    Parte 2:
    - valutare la sicurezza e la tollerabilità di itacitinib IR alla RP2D.
    - valutare l’efficacia di itacitinib IR alla RP2D per quanto riguarda il miglioramento dei sintomi della MF alla settimana 24, in quei pazienti che avevano un TSS basale =10.
    - valutare l’efficacia di itacitinib IR per quanto riguarda il miglioramento della qualità della vita.
    - valutare l’efficacia di itacitinib IR alla RP2D per quanto riguarda la PGIC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged 18 years or older at the time of signing the informed consent
    2. Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
    3. At least Intermediate 1 risk MF according to the DIPSS.
    4. Prior treatment with ruxolitinib and/or fedratinib monotherapy:
    a. Previously treated with ruxolitinib and/or fedratinib monotherapy for PMF or secondary MF for not more than 6 months if treatment was discontinued due to recurrent Grade 4 thrombocytopenia; = Grade 3 anemia, hemorrhage, or hematoma; or allergy/other intolerance to ruxolitinib or fedratinib
    OR
    b. Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF:
    - For at least 3 months with initial response but regrowth of spleen on imaging or by palpation compared with baseline;
    OR
    - For at least 28 days if treatment is complicated by recurrent Grade 4 thrombocytopenia; = Grade 3 anemia, hemorrhage, or hematoma; or allergy/other intolerance to ruxolitinib or fedratinib.
    5. Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume = 450 cm3 on imaging assessed during screening.
    6. Allogeneic stem cell transplant not planned.
    7. Platelet = 50 × 109/L at screening.
    8. Ability to comprehend and willingness to sign a written ICF for the study.
    9. Willingness to avoid pregnancy or fathering children
    1. Di età pari o superiore a 18 anni al momento della firma del consenso informato
    2. Diagnosi di MF primaria che soddisfa i criteri 2016 dell'OMS per PMF palese o MF secondaria (PPV-MF o PET-MF) che soddisfa i criteri IWG-MRT 2008.
    3. Almeno Intermedio 1 rischio MF secondo il DIPSS.
    4. Precedente trattamento con ruxolitinib e / o fedratinib in monoterapia:
    un. Precedentemente trattati con ruxolitinib e / o fedratinib in monoterapia per PMF o MF secondaria per non più di 6 mesi se il trattamento è stato interrotto a causa di trombocitopenia ricorrente di grado 4; Anemia, emorragia o ematoma di grado = 3; o allergia / altra intolleranza a ruxolitinib o fedratinib
    O
    b. Attualmente in trattamento con ruxolitinib o fedratinib in monoterapia per PMF o MF secondaria:
    - Per almeno 3 mesi con risposta iniziale ma ricrescita della milza all'imaging o alla palpazione rispetto al basale;
    O
    - Per almeno 28 giorni se il trattamento è complicato da trombocitopenia ricorrente di grado 4; Anemia, emorragia o ematoma di grado = 3; o allergia / altra intolleranza a ruxolitinib o fedratinib.
    5. Splenomegalia definita come milza palpabile almeno 5 cm sotto il margine costale sinistro o volume = 450 cm3 all'imaging valutato durante lo screening.
    6. Trapianto di cellule staminali allogeniche non pianificato.
    7. Piastrine = 50 × 109 / L allo screening.
    8. Capacità di comprensione e disponibilità a firmare un ICF scritto per lo studio.
    9. Disponibilità ad evitare la gravidanza o la procreazione di figli
    E.4Principal exclusion criteria
    1. Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
    2. Record of = 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening
    3. For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
    4. Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
    5. Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
    6. Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
    7. Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
    8. ECOG performance status = 3
    9. Life expectancy less than 24 weeks
    10. Not willing to receive RBC or platelet transfusions
    11. Participants with laboratory values at screening defined in Table 11 of protocol
    12. Significant concurrent, uncontrolled medical condition, including but not limited to the following: Gastrointestinal, Cardiovascular
    13. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful according to the guidance provided in Section 8.3.4 of the protocol.
    14. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
    15. Hepatitis: Evidence of HBV or HCV infection or risk of reactivation.
    16. Known HIV infection.
    17. Current use of prohibited medication as described in Section 6.6.9 of protocol.
    18. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
    19. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
    20. Women who are pregnant or breastfeeding.
    21. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of itacitinib IR and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
    22. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including: inability to self-administer itacitinib IR; difficulty attending required study visits; a comorbid condition that poses a significant risk to the participant or may interfere with interpretation of study data.
    23. The following participants are excluded in France: vulnerable populations according to article L.1121-6 of the French Public Health Code and adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
    1. Precedente trattamento con un inibitore della JAK diverso da ruxolitinib o fedratinib
    2. Registrazione di = 10% di blasti mieloidi nel sangue periferico (su striscio di sangue periferico) o nel midollo osseo prima o al momento dello screening
    3. Per i partecipanti a ruxolitinib o fedratinib, che non possono essere ridotti gradualmente da quel trattamento nel corso di 14 giorni senza corticosteroidi, idrossiurea o altri agenti
    4. Trattamento con ruxolitinib, fedratinib o altra terapia diretta alla MF (approvata o sperimentale) entro 2 settimane dal giorno 1
    5. Precedente splenectomia o irradiazione splenica entro 6 mesi prima di ricevere la prima dose di itacitinib
    6. Impossibile o non disposto a sottoporsi a scansioni MRI o TC seriali per la misurazione del volume della milza
    7. Impossibile o non disposto a completare il diario MFSAF v4.0 su base giornaliera durante lo studio
    8. Performance status ECOG = 3
    9. Aspettativa di vita inferiore a 24 settimane
    10. Non disposto a ricevere trasfusioni di globuli rossi o piastrine
    11. Partecipanti con valori di laboratorio allo screening definiti nella Tabella 11 del protocollo
    12. Condizioni mediche concomitanti significative, non controllate, incluse ma non limitate a quanto segue: gastrointestinale, cardiovascolare
    13. Anamnesi o presenza di un ECG anormale che, a giudizio dello sperimentatore, è clinicamente significativo secondo le indicazioni fornite nella Sezione 8.3.4 del protocollo.
    14. Malattia infettiva attiva cronica o in corso che richiede antibiotici sistemici, trattamento antifungino o antivirale.
    15. Epatite: evidenza di infezione da HBV o HCV o rischio di riattivazione.
    16. Nota infezione da HIV.
    17. Uso corrente di farmaci proibiti come descritto nella Sezione 6.6.9 del protocollo.
    18. Incapacità o improbabilità del partecipante di rispettare il programma di dosaggio e le valutazioni dello studio, secondo il parere dello sperimentatore.
    19. Recupero inadeguato da tossicità e / o complicazioni da un intervento chirurgico importante prima di iniziare la terapia.
    20. Donne in gravidanza o in allattamento.
    21. Qualsiasi condizione che, a giudizio dello sperimentatore, interferirebbe con la piena partecipazione allo studio, compresa la somministrazione di itacitinib IR e la partecipazione alle visite di studio richieste; comportare un rischio significativo per il partecipante; o interferire con l'interpretazione dei dati dello studio.
    22. Qualsiasi condizione che, a giudizio dello sperimentatore, interferirebbe con la piena partecipazione allo studio, tra cui: incapacità di auto-somministrarsi itacitinib IR; difficoltà a partecipare alle visite di studio richieste; una condizione di comorbilità che pone un rischio significativo per il partecipante o può interferire con l'interpretazione dei dati dello studio.
    23. I seguenti partecipanti sono esclusi in Francia: le popolazioni vulnerabili ai sensi dell'articolo L.1121-6 del Codice della sanità pubblica francese e gli adulti sotto protezione legale o che non sono in grado di esprimere il loro consenso ai sensi dell'articolo L.1121-8 del Pubblico francese Codice sanitario.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Safety and tolerability through assessments of frequency and severity of AEs; changes in clinical safety assessments; changes in clinical laboratory parameters.
    Part 2: SRR at Week 24, where SRR is defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35% when compared with baseline
    Parte 1: Sicurezza e tollerabilità attraverso valutazioni della frequenza e gravità degli AE (Adverse Evens, eventi avversi); alterazioni nelle valutazioni della sicurezza clinica; alterazioni nei parametri clinici di laboratorio.
    Parte 2: SRR alla settimana 24, dove per SRR s’intende la percentuale di partecipanti che mostrano una riduzione del volume della milza (in base alla diagnostica per immagini) di almeno il 35% rispetto al baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    Safety and tolerability through assessments of frequency and severity of AEs; changes in clinical safety assessments; changes in clinical laboratory parameters. TSS response rate at Week 24, where TSS response is defined as the proportion of participants who achieve at least 50% reduction in TSS
    over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before initiation of itacitinib IR (baseline). The mean change (from Day 1 vs Week 12 and Week 24) in the 5 multiitem functional scale scores and the multi-item global health status scale score (EORTC QLQ-C30).
    Sicurezza e tollerabilità attraverso valutazioni della frequenza e gravità degli AE (Adverse Evens, eventi avversi); alterazioni nelle valutazioni della sicurezza clinica; alterazioni nei parametri clinici di laboratorio. Tasso di risposta TSS alla settimana 24, dove per tasso di risposta TSS s’intende la percentuale di partecipanti che ottengono una riduzione di almeno il 50% nel TSS nei 28 giorni immediatamente precedenti la fine della settimana 24 rispetto ai 7 immediatamente precedenti l’inizio di itacitinib IR (basale). Il cambiamento medio (dal giorno 1 rispetto alle settimane 12 e 24) nei 5 punteggi della scala funzionale multi-item e nel punteggio della scala dello stato di salute complessivo multi-item (EORTC QLQ-C30).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    in aperto
    open
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    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 months8
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 73
    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)
    Patients will remain on treatment as long as they are receiving clinical benefit and have not met any criteria for study w/d, until Week 48, at which time they will be eligible for enrollment into an itacitinib rollover study. (Separate protocol.)
    I pazienti rimarranno in trattamento fintanto che ricevono benefici clinici e non hanno soddisfatto alcun criterio per lo studio w / d, fino alla settimana 48, momento in cui saranno eleggibili per l'arruolamento in uno studio di rollover itacitinib. (Protocollo separato.)
    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 Decision2021-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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