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    The EU Clinical Trials Register currently displays   43889   clinical trials with a EudraCT protocol, of which   7298   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).

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    EudraCT Number:2021-002365-18
    Sponsor's Protocol Code Number:CP543.5002
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-06
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2021-002365-18
    A.3Full title of the trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the long-term efficacy and safety following administration of CTP-543 in adult patients with moderate to severe alopecia areata
    A.4.1Sponsor's protocol code numberCP543.5002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05041803
    A.5.4Other Identifiers
    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 SponsorSun Pharmaceutical Industries, 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 supportSun Pharmaceutical Industries, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLinical France SARL
    B.5.2Functional name of contact pointMedical Manager
    B.5.3 Address:
    B.5.3.1Street Address52 Take Ionescu Boulevard
    B.5.3.2Town/ cityTimisoara
    B.5.3.3Post code300073
    B.5.4Telephone number+40256207271
    B.5.5Fax number+40256207273
    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 namedeuruxolitinib (Tablet 8 mg every 12 hours)
    D.3.2Product code CTP-543
    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 INNdeuruxolitinib
    D.3.9.1CAS number 2147706-60-1
    D.3.9.2Current sponsor codeCTP-543 phosphate
    D.3.9.3Other descriptive nameC-21543; D8-RUXOLITINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10001761
    E.1.2Term Alopecia areata
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with moderate to severe alopecia areata
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent, and authorization for release and use of protected health information.
    2.Have completed a 24-week Treatment Period in a previous qualifying CTP-543 clinical trial.
    3.Female subjects are eligible to participate if at least one of the following conditions applies:
    a)Is a woman of childbearing potential (WOCBP) and using a medically highly effective form of birth control with a failure rate less than 1% per year from at least 4 weeks prior to Baseline until at least 30 days following last dose of study drug. Examples of medically highly effective birth control methods include:
    i.Combined (estrogen and progestogen containing) hormonal contraception (oral, patch, vaginal ring)
    ii.Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
    iii.Intrauterine device or intrauterine hormone-releasing system
    iv.Bilateral tubal occlusion
    v.Vasectomized partner (partner is the sole sexual partner of the WOCBP trial participant and the vasectomized partner has received medical assessment of the surgical success)
    vi.Sexual abstinence (reliable as refraining from heterosexual intercourse during the above-mentioned period)
    b) Is not a WOCBP:
    i. Premenopausal with one of the following:
    a. Documented hysterectomy;
    b. Documented bilateral salpingectomy;
    c. Documented bilateral oophorectomy.
    ii. Postmenopausal (cessation of menses for at least 12 months prior to screening)
    Postmenopausal is defined as no menses for 12 months without an alternative medical cause. In addition, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm postmenopausal in women under 60 years old and not using hormonal contraception or hormone replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Females on HRT and whose menopausal status is in doubt will be required to use one of the nonestrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment
    4.Male participants must:
    a.Agree to use, with their partners, male contraception (condom) and one of the highly effective contraceptive methods listed in Inclusion Criterion 3, from Baseline until at least 90 days following last dose of study drug.
    b.Refrain from donating sperm during the study and for at least 90 days after the end of the study.
    5.Willing to comply with the study visits and requirements of the study protocol.
    1.Írásos tájékoztatás utáni beleegyezés, valamint engedély a védett egészségügyi adatok kiadására és felhasználására.
    2.A beteg befejezte a 24-hetes kezelési időszakot egy korábbi minősítő CTP-543 klinikai vizsgálatban.
    3.A női alanyok akkor alkalmasak a részvételre, ha az alábbi feltételek közül legalább egy teljesül:
    a)Fogamzóképes nő (woman of childbearing potential – WOCBP) és orvosilag nagyon hatékony fogamzásgátló módszert használ – amelynél a hibaarány kevesebb mint 1% évente, a kiindulás előtti legalább 4. héttel a vizsgálati készítmény utolsó adagja utáni legalább 30 napig. Példák az orvosilag nagyon hatékonynak számító fogamzásgátló módszerekre:
    i.Kombinált (ösztrogént és progesztogént tartalmazó) hormonális fogamzásgátlás (orális, tapasz, hüvelygyűrű)
    ii.Csak progesztogént tartalmazó hormonális fogamzásgátlás az ovuláció gátlásával (orális, injekció, implantátum)
    iii.Méhen belüli eszköz vagy méhen belüli hormonkibocsátó rendszer
    iv.Kétoldali petevezeték-elzárás
    v.Vazektomizált partner (a partner a WOCBP vizsgálati résztvevő egyedüli szexuális partnere, és a műtét sikerét orvosilag értékelték a vazektomizált partnernél)
    vi.Szexuális absztinencia (megbízható abban, hogy tartózkodik a heteroszexuális közösüléstől a fent említett időszak alatt)
    b)Nem WOCBP:
    i.Premenopauza az alábbiak egyikével:
    a.Dokumentált hiszterektómia;
    b.Dokumentált kétoldali szalpingektómia;
    c.Dokumentált kétoldali petefészek-eltávolítás.
    ii.Posztmenopauzában van (a szűrés előtt legalább 12 hónapja nem menstruál)
    A posztmenopauza úgy határozható meg, hogy 12 hónapja nem jelentkezett menstruáció, és ennek nincs más orvosi oka. Ezenkívül a posztmenopauzális tartományban lévő magas follikulus stimuláló hormon (FSH) szint használható a posztmenopauza megerősítésére 60 év alatti nőknél, akik nem használnak hormonális fogamzásgátlást vagy hormonpótló terápiát (hormone replacement therapy – HRT). Azonban 12 hónapos amenorrhoea hiányában egyetlen FSH-mérés nem elegendő. A HRT-t alkalmazó nőknek, akiknek a menopauzális státusza kétséges, az ösztrogént nem tartalmazó hormonális, nagy hatékonyságú fogamzásgátló módszerek egyikét kell alkalmazniuk, ha a HRT-t a vizsgálat során folytatni kívánják. Egyébként abba kell hagyniuk a HRT-t, hogy lehetővé tegyék a posztmenopauzális státusz megerősítését a vizsgálatba való bevonás előtt.
    4.A férfi résztvevőknek kötelezően:
    a.Bele kell egyezniük, hogy partnereikkel férfi fogamzásgátlást (óvszert) és a 3. beválasztási kritériumban felsorolt, nagy hatékonyságú fogamzásgátló módszerek egyikét alkalmazzák a kiindulástól a vizsgálati készítmény utolsó adagja után legalább 90 napig.
    b.Tartózkodniuk kell a spermaadományozástól a vizsgálat ideje alatt és a vizsgálat vége után még legalább 90 napig.
    5.Hajlandó betartani a vizsgálati viziteket és a vizsgálati protokoll követelményeit.
    E.4Principal exclusion criteria
    1.Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body.
    2.Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication.
    3.Donation of blood at any point throughout the study and for 30 days after last dose of study medication.
    4.Most recent hematologic parameters do not permit continued dosing; i.e., criteria for withholding IP have been met and have not recovered to values required to resume dosing.
    5.Any medical, psychiatric, or social condition that is likely to unfavorably affect the risk-benefit of continued study participation, interfere with study compliance, or confound safety or efficacy assessments.
    1.Aktív fejbőrgyulladás, pikkelysömör vagy seborrheás dermatitisz, amely helyi kezelést igényel a fejbőrön, jelentős fejbőrsérülés vagy egyéb fejbőrbetegség, amely zavarhatja a SALT-értékelést, vagy kezeletlen aktinikus keratózis a test bármely részén.
    2.Olyan nők, akik szoptatnak, terhesek vagy teherbe kívánnak esni a vizsgálat ideje alatt és a vizsgálati készítmény utolsó adagja után még 30 napig.
    3.Véradás a vizsgálat során bármikor és a vizsgálati készítmény utolsó adagja után még 30 napig.
    4.A legutóbbi hematológiai paraméterek nem teszik lehetővé a folyamatos adagolást, azaz az IP-visszatartás kritériumai teljesültek, és az adagolás folytatásához szükséges értékekre nem tértek vissza.
    5.Bármilyen orvosi, pszichiátriai vagy szociális állapot, amely valószínűleg kedvezőtlenül befolyásolja a vizsgálatban való további részvétel kockázat-előny arányát, nem egyeztethető össze a vizsgálati előírások betartásával, vagy zavarja a biztonságossági vagy hatásossági értékeléseket.
    E.5 End points
    E.5.1Primary end point(s)
    Safety of CTP-543 will be assessed by evaluating adverse event, clinical laboratories, physical examinations, vital signs, concomitant medications, and electrocardiogram results.
    Efficacy of CTP-543 will include all patients who receive study drug and have at least 1 post-treatment SALT assessment in this study. Relative change in SALT score over time will be summarized descriptively by visit, as appropriate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After at least 1 post-treatment SALT assessment (week 4) in this study
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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 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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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: 403
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 407
    F.4.2.2In the whole clinical trial 407
    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)
    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 Decision2022-01-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-04
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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