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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2019-003430-16
    Sponsor's Protocol Code Number:APHP180613
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-003430-16
    A.3Full title of the trial
    Safety and efficacy of itacitinib in adults with systemic sclerosis: a phase II, randomized, controlled trial - SCLERITA
    Etude SCLERITA - Tolérance et efficacité de l’itacitinib dans la sclérodermie systémique. Etude prospective, randomisée, contrôlée, en double-aveugle, multicentrique
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of itacitinib in adults with systemic sclerosis
    Tolérance et efficacité de l’itacitinib dans la sclérodermie systémique
    A.3.2Name or abbreviated title of the trial where available
    SCLERITA
    SCLERITA
    A.4.1Sponsor's protocol code numberAPHP180613
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841738
    B.5.5Fax number33144841701
    B.5.6E-mailjosephine.braun@aphp.fr
    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 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.3.9.2Current sponsor codeINCB039110
    D.3.9.4EV Substance CodeSUB183665
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening
    Patients présentant une sclérodermie systémique (ScS) diffuse nouvellement diagnostiquée ou active au moment de l’évaluation initiale
    E.1.1.1Medical condition in easily understood language
    Patients with newly or active diffuse Systemic sclerosis (SSc) at the time of screening
    Patients présentant une sclérodermie systémique (ScS) diffuse nouvellement diagnostiquée ou active au moment de l’évaluation initiale
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of this study is to show a decrease of skin fibrosis, as evaluated by the modified Rodnan skin score, after 360 days of treatment, in patients with diffuse SSc treated with itacitinib when compared to patients treated with a placebo
    L'objectif principal de cette étude est de montrer une diminution de la fibrose cutanée, évaluée par le score cutané de Rodnan modifié, après 360 jours de traitement, chez les patients atteints de ScS diffuse traités par itacitinib par rapport aux patients traités avec un placebo.
    E.2.2Secondary objectives of the trial
    - to evaluate the safety of itacitinib in patients with SSc
    - to compare the efficacy of itacitinib versus placebo in terms of disease activity, quality of life and disability
    - évaluer la tolérance de l'itacitinib chez les patients atteints de ScS ;
    - comparer l'efficacité de l'itacitinib par rapport au placebo en termes d'activité de la maladie, de qualité de vie et de handicap.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patient (>/= 18 years old),
    - Patient with a diagnosis of diffuse SSc, as defined by the American College of Rheumatology / EULAR 2013 criteria,
    - Patient with a SSc disease duration of less than 36 months (defined as time from first non-Raynaud phenomenon manifestation) or with an active SSc disease, as defined by EUSTAR disease activity score,
    - Patient with a modified Rodnan skin score (mRSS) > /= 10 and < /= 35 units at screening,
    - Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the 12 months duration of the study,
    - Patient able to give written informed consent prior to participation in the study,
    - Affiliation to a social security scheme (profit or being entitled)
    - Patient adulte (≥ 18 ans),
    - Patient avec un diagnostic de ScS diffuses, telles que définies par les critères de l'American College of Rheumatology / EULAR 2013,
    - Patient avec une durée de maladie ScS inférieure à 36 mois (définie comme le temps écoulé depuis la première manifestation du phénomène non Raynaud) ou avec une maladie ScS active, telle que définie par le score d'activité de la maladie EUSTAR,
    - Patient avec un score cutané de Rodnan modifié (mRSS) ≥ 10 et ≤ 35 unités au dépistage,
    - Test de grossesse négatif pour les femmes en capacité de procréer, les femmes en capacité de procréer doivent utiliser une contraception fiable pendant la durée de 12 mois de l'étude,
    - Patient capable de donner un consentement éclairé écrit avant de participer à l'étude,
    - Affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit).
    E.4Principal exclusion criteria
    - Previous treatment with itacitinib or a Janus kinase (JAK) inhibitor,
    - Contra-indications to itacitinib or Janus kinase inhibitor,
    - Failure to sign the informed consent or unable to consent
    - Patient participating in another investigational therapeutic study,
    - Current, or history of recurrent infections, including HBV, HCV, HIV
    - Patient with other uncontrolled diseases, including drug or alcohol abuse, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
    - Patient suspected not to be observant to the proposed treatments,
    - Patient who have white blood cell count ≤ 4,000/mm3,
    - Patient who have platelet count ≤ 100,000/mm3,
    - Patients who have ALT or AST level greater that 3 times the upper limit of normal
    - Patient who have triglyceride level greater than 5g/L
    - Pregnant or breastfeeding woman.
    - Patient receiving or having received mycophenolate mofetil or methotrexate within the last month (possible inclusion beyond one month),
    - Patient receiving or having received cyclophosphamide or rituximab within the last three months (possible inclusion beyond 3 months),
    - Patient receiving or having received a biotherapy (anti-TNF, abatacept or tocilizumab) in the last 3 months (possible inclusion beyond 3 months).
    - Traitement antérieur par itacitinib ou un inhibiteur de la Janus kinase (JAK),
    - Contre-indications à l'itacitinib ou à un inhibiteur de Janus kinase,
    - Absence de signature du consentement éclairé ou impossibilité de consentir,
    - Patient participant à une autre étude thérapeutique interventionnelle,
    - Infections actuelles ou récurrentes, y compris le VHB, le VHC, le VIH,
    - Patient atteint d'autres maladies incontrôlées, y compris l'abus de drogues ou d'alcool, les maladies psychiatriques graves, qui pourraient interférer avec la participation à l'essai conformément au protocole,
    - Patient suspecté de ne pas être observant aux traitements proposés,
    - Patient dont le nombre de globules blancs est ≤ 4000 / mm3,
    - Patient présentant une numération plaquettaire ≤ 100 000 / mm3,
    - Patients dont le niveau d'ALT ou d'AST est supérieur à 3 fois la limite supérieure de la normale,
    - Patient dont le taux de triglycérides est supérieur à 5 g/L,
    - Femme enceinte ou allaitante,
    - Patient recevant ou ayant reçu du mycophénolate mofétil ou du méthotrexate au cours du dernier mois (inclusion possible au-delà d'un mois),
    - Patient recevant ou ayant reçu du cyclophosphamide ou du rituximab au cours des trois derniers mois (inclusion possible au-delà de 3 mois),
    - Patient recevant ou ayant reçu une biothérapie (anti-TNF, abatacept ou tocilizumab) au cours des 3 derniers mois (inclusion possible au-delà de 3 mois).
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the change in modified Rodnan skin score at 360 days.
    Le critère d’évaluation principal est le changement du score cutané de Rodnan modifié à 360 jours.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 360
    Jour 360
    E.5.2Secondary end point(s)
    Security profile:
    - Proportion of patients deceased at 360 days
    - Adverse events at 180 and 360 days
    - Severe adverse events at 180 and 360 days.

    SSc disease activity
    - Change in modified Rodnan skin score at 90, 180, 270 days
    - Proportion of patients with an improved modified Rodnan skin score at 90, 180, 270, 360 days
    - Proportion of patients with an active disease according to the EUSTAR SSc activity score at 180 and 360 days.
    - Change in the Combined Response Index in Diffuse Systemic Sclerosis (CRISS) score
    - Physicians and patients visual analogue scales

    Quality of life and disability
    - SF-36 and EQ5D scales
    - HAQ-DI scale
    • Pour la tolérance :
    - Proportion de patients décédés à 360 jours
    - Evénements indésirables à 180 et 360 jours
    - Événements indésirables graves à 180 et 360 jours.

    • Pour l’efficacité :
    - Changement du score cutané modifié de Rodnan à 90, 180, 270 jours.
    - Proportion de patients avec un score cutané de Rodnan modifié amélioré à 90, 180, 270, 360 jours.
    - Proportion de patients avec une maladie active selon le score d'activité EUSTAR ScS à 180 et 360 jours.
    - Changement de l'indice combiné de réponse dans la sclérose systémique diffuse (CRISS).
    - Échelles visuelles analogiques (médecins et patients).
    • Qualité de vie et handicap :
    - scores SF-36 et EQ5D
    - score HAQ-DI
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 90, 180, 270, 360 days
    aux jours 90, 180, 270 et 360
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualité de vie
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned60
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state74
    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)
    Best care for the clinical condition
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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