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    Summary
    EudraCT Number:2021-006885-19
    Sponsor's Protocol Code Number:ARQ-151-313
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-05-25
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-006885-19
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis
    Badanie przedłużone, fazy 3, wieloośrodkowe, prowadzone metodą otwartej próby, oceniające długoterminowe bezpieczeństwo 0,15% kremu ARQ-151 oraz 0,05% kremu ARQ-151 u pacjentów z atopowym zapaleniem skóry
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis
    Badanie przedłużone, fazy 3, wieloośrodkowe, prowadzone metodą otwartej próby, oceniające długoterminowe bezpieczeństwo 0,15% kremu ARQ-151 oraz 0,05% kremu ARQ-151 u pacjentów z atopowym zapaleniem skóry
    A.4.1Sponsor's protocol code numberARQ-151-313
    A.5.4Other Identifiers
    Name:INDNumber:135681
    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 SponsorArcutis Biotherapeutics, 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 supportArcutis Biotherapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArcutis Biotherapeutics, Inc.
    B.5.2Functional name of contact pointThe Information at Arcutis
    B.5.3 Address:
    B.5.3.1Street Address3027 Townsgate Road, Suite 300
    B.5.3.2Town/ cityWestlake Village
    B.5.3.3Post codeCA 91361
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18054185006
    B.5.5Fax number+18054185006
    B.5.6E-mailinformation@arcutis.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 nameARQ-151
    D.3.2Product code ARQ-151
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRoflumilast
    D.3.9.1CAS number 162401-32-3
    D.3.9.2Current sponsor codeARQ-151
    D.3.9.4EV Substance CodeSUB10358MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,15
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameARQ-151
    D.3.2Product code ARQ-151
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRoflumilast
    D.3.9.1CAS number 162401-32-3
    D.3.9.2Current sponsor codeARQ-151
    D.3.9.4EV Substance CodeSUB10358MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,05
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atopic Dermatitis
    Atopowe zapalenie skóry
    E.1.1.1Medical condition in easily understood language
    Atopic Dermatitis
    Atopowe zapalenie skóry
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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
    To assess long-term safety in a multicenter, open-label, single-arm study in subjects with atopic dermatitis treated with ARQ-151 cream 0.15% QD (subjects ≥ 6 years of age) or ARQ‑151 cream 0.05% QD (subjects 2 to 5 years of age) after completing one of three Phase 3 studies (ARQ-151-311, ARQ‑151‑312, or ARQ-151-315).
    Ocena długoterminowego bezpieczeństwa w wieloośrodkowym, prowadzonym metodą otwartej próby, jednoramiennym badaniu z udziałem pacjentów z atopowym zapaleniem skóry leczonych 0,15% kremem ARQ-151 raz dziennie (pacjenci w wieku ≥ 6 lat) lub 0,05% kremem ARQ‑151 raz dziennie (pacjenci
    od 2 do 5 lat), którzy ukończyli jedno z trzech badań fazy 3 (ARQ-151-311, ARQ‑151‑312 lub ARQ-151-315).
    E.2.2Secondary objectives of the trial
    Not applicable
    Nie dotyczy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
    2.Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
    3.Subjects with atopic dermatitis who met eligibility criteria for and successfully completed ARQ-151-311 or ARQ-151-312 or ARQ-151-315 through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
    4.Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial. The use of abstinence as a contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice and an acceptable backup method has been identified if the subject becomes sexually active.
    5.Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
    6.Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
    1.W przypadku pacjentów dorosłych: Uczestnicy ze zdolnością prawną do podpisania i udzielenia świadomej zgody. W przypadku pacjentów pediatrycznych i nastoletnich: Świadoma zgoda rodzica/ów lub opiekuna prawnego oraz, jeśli wiek jest odpowiedni, zgoda pacjenta, zgodnie
    z wymogami lokalnego prawa.
    2.Pacjenci płci męskiej i żeńskiej w wieku 2 lat i starsi. (W ośrodkach zlokalizowanych w prowincji Québec w Kanadzie zostaną włączeni wyłącznie pacjenci w wieku 18 lat i starsi.)
    3.Pacjenci z atopowym zapaleniem skóry, którzy spełnili kryteria kwalifikowalności i pomyślnie ukończyli ARQ-151-311 lub ARQ-151-312 lub ARQ-151-315 do Tygodnia 4, oraz są w stanie i kwalifikują się do włączenia, do tego długoterminowego badania bezpieczeństwa podczas wizyty w Tygodniu 4 poprzedzającego badania.
    4.Kobiety zdolne do zajścia w ciążę muszą mieć ujemny wynik testu ciążowego z moczu na wszystkich wizytach badania. Ponadto aktywne seksualnie kobiety zdolne do zajścia w ciążę muszą wyrazić zgodę na stosowanie co najmniej jednej formy wysoce skutecznej lub barierowej metody antykoncepcji przez cały okres trwania badania. Stosowanie abstynencji jako środka antykoncepcyjnego jest dopuszczalne, o ile jest to stała część wyboru stylu życia oraz określona została akceptowalna zastępcza metoda antykoncepcji, jeśli pacjentka stanie się aktywna seksualnie.
    5.Kobiety niezdolne do zajścia w ciążę powinny być przed rozpoczęciem miesiączkowania lub po menopauzie z samoistnym brakiem miesiączki przez co najmniej 12 miesięcy (stan pomenopauzalny potwierdzony testem FSH w poprzedzającym badaniu) lub przeszły sterylizację chirurgiczną (metody trwałej sterylizacji obejmują histerektomię, obustronne usunięcie jajników lub obustronną salpingektomię).
    6.Pacjenci i rodzic(e)/opiekun(owie) prawni są uważani za wiarygodnych i zdolnych do przestrzegania Protokołu i harmonogramu wizyt, zgodnie z oceną Badacza.
    E.4Principal exclusion criteria
    1.Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in studies ARQ-151-311 or ARQ-151-312 or ARQ‑151‑315.
    2.Subjects that use any Excluded Medications and Treatments (see Table 2).
    3.Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements (e.g., molluscum contagiosum).
    4.Subjects with known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.
    5.Known allergies to excipients in ARQ-151 cream (petrolatum, isopropyl palmitate, methylparaben, propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetylstearyl alcohol, dicetyl phosphate and ceteth-10 phosphate).
    6.Subjects who cannot discontinue the use of strong cytochrome P‑450 CYP3A4 inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.
    7.Subjects who cannot discontinue the use of strong cytochrome P‑450 CYP3A4 inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, and rifampin during the study period.
    8.Known or suspected:
    a.Severe renal insufficiency (defined as calculated creatinine clearance < 30mL/min) Refer to the creatinine levels from the following visits:
    •ARQ-151-311/ARQ-151-312 studies: Screening Visit for subjects ages 6-11 and Baseline/Day 1 for subjects ≥12 years old (for subjects 12-18 years old, if screening lab tests were collected within 3 weeks of Baseline/Day 1, screening results will be used)
    •ARQ-151-315 study: Screening Visit
    b.Moderate to severe hepatic disorders (Child-Pugh B or C)
    c.History of severe depression, suicidal ideation or behavior
    9.Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
    10.Subjects with any known serious medical condition (e.g., uncontrolled hypo- or hyper-thyroidism) or clinically significant laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
    11.Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
    12.Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
    13.Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator’s opinion, makes them unsuitable for clinical study participation.
    14.Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151) living in the same house.
    1.Pacjenci, u których wystąpiło zdarzenie niepożądane (AE) związane z leczeniem lub ciężkie zdarzenie niepożądane (SAE), które wykluczało dalsze leczenie kremem ARQ-151 w badaniach ARQ-151-311 lub ARQ-151-312 lub ARQ‑151-315.
    2.Pacjenci, którzy stosują którykolwiek z Wykluczonych Leków i Terapii (patrz Tabela 2).
    3.Pacjenci z chorobami skóry innymi niż AZS, które w opinii Badacza, mogłyby zakłócać ocenę wpływu leku badanego na AZS. Pacjenci z jakimkolwiek schorzeniem na leczonym obszarze, które w opinii Badacza może podważyć pomiary skuteczności, np. mięczak zakaźny.
    4.Pacjenci ze stwierdzonymi genetycznymi schorzeniami dermatologicznymi, które pokrywają się z AZS, takimi jak zespół Nethertona.
    5.Rozpoznane alergie na substancje pomocnicze w kremie ARQ-151 (wazelina, palmitynian izopropylu, metyloparaben, propyloparaben, eter monoetylowego glikolu dietylenowego, glikol heksylenowy, alkohol cetylostearylowy, fosforan dwucetylowy i fosforan cetet-10).
    6.Pacjenci, którzy nie mogą przerwać stosowania silnych inhibitorów cytochromu P-450 CYP3A4 np. indynawiru, nelfinawiru, rytonawiru, klarytromycyny, itrakonazolu, ketokonazolu, nefazodonu, sakwinawiru, suboksonu i telitromycyny, w czasie trwania badania.
    7.Pacjenci, którzy nie mogą przerwać stosowania silnych induktorów cytochromu P-450 CYP3A4, np. efawirenzu, newirapiny, glikokortykoidów, barbituranów (w tym fenobarbitalu), fenytoiny, ryfampicyny w czasie trwania badania.
    8.Stwierdzone lub podejrzewane:
    a.Ciężka niewydolność nerek (definiowana jako obliczony klirens kreatyniny <30 mL/min)
    Odnieś się do poziomów kreatyniny z następujących wizyt:
    •Badania ARQ-151-311/ARQ-151-312: Wizyta Skriningowa dla pacjentów w wieku 6-11 lat oraz Baseline/Dzień 1 dla pacjentów w wieku ≥12 lat (dla pacjentów w wieku 12-18 lat, jeśli testy laboratoryjne na skriningu zostały wykonane w ciągu 3 tygodni od Baseline/Dzień 1, wyniki badań ze skriningu zostaną użyte)
    •Badanie ARQ-151-315: Wizyta Skriningowa
    b.Umiarkowane do ciężkich zaburzenia czynności wątroby (klasa B lub C w skali Child-Pugh)
    c.Historia ciężkiej depresji, myśli lub zachowań samobójczych
    9.Kobiety, które są w ciąży, chcące zajść w ciążę w trakcie badania lub karmiące piersią.
    10.Pacjenci z jakimkolwiek znanym poważnym schorzeniem (np. niekontrolowana niedoczynność lub nadczynność tarczycy) lub klinicznie istotnymi nieprawidłowościami laboratoryjnymi, które uniemożliwiłyby udział w badaniu lub naraziłyby pacjenta na znaczne ryzyko, zgodnie z oceną Badacza.
    11.Pacjenci z historią przewlekłego nadużywania alkoholu lub narkotyków w ciągu 6 miesięcy od rozpoczęcia przyjmowania leku badanego.
    12.Obecny lub przebyty nowotwór w ciągu 5 lat, z wyjątkiem w pełni wyleczonego raka podstawnokomórkowego skóry, raka płaskonabłonkowego skóry lub raka in situ szyjki macicy.
    13.Pacjenci oraz rodzic(e)/opiekun(owie) prawni, którzy nie są w stanie komunikować się, czytać lub zrozumieć lokalnego(ych) języka(ów), lub u których występuje inny stan, który w ocenie Badacza sprawia, że nie nadają się oni do udziału w badaniu klinicznym.
    14.Pacjenci będący członkami rodziny pracowników ośrodka badania klinicznego, personelu badawczego lub sponsora, lub członkowie rodziny pacjentów włączonych do badania (pacjenci włączeni do innych badań ARQ-151) mieszkający w tym samym domu.
    E.5 End points
    E.5.1Primary end point(s)
    •Adverse Events (AEs)
    •Serious Adverse Events (SAEs)
    •Zdarzenia niepożądane (AE)
    •Ciężkie zdarzenia niepożądane (SAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1, Week 4, Week 12, Week 18, Week 24, Week 30, Week 36, Week 44, Week 52/ET
    Dzień 1, Tydzień 4, Tydzień 12, Tydzień 18, Tydzień 24, Tydzień 30, Tydzień 36, Tydzień 44, Tydzień 52/ET
    E.5.2Secondary end point(s)
    •Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) value 0 or 1 at each assessment
    •vIGA-AD success (defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline)
    •WI-NRS score over time
    •EASI score over time
    •Wartość 0 lub 1 podczas każdej oceny w skali vIGA-AD
    •Sukces vIGA-AD (zdefiniowany jako wartość 0 lub 1 w skali vIGA-AD, plus poprawa o 2 stopnie w porównaniu z baseline)
    •Wynik WI-NRS na przestrzeni czasu
    •Wynik EASI na przestrzeni czasu

    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Week 4, Week 12, Week 24, Week 36, Week 52/ET
    Dzień 1, Tydzień 4, Tydzień 12, Tydzień 24, Tydzień 36, Tydzień 52/ET
    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 No
    E.6.6Pharmacokinetic Yes
    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.7.1.3.1Other 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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned29
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Dominican Republic
    Canada
    United States
    Poland
    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
    LVLS
    Ostatnia wizyta ostatniego pacjenta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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 Yes
    F.1.1Number of subjects for this age range: 1324
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 986
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 338
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1500
    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)
    Patient will return to standard of care treatment per study doctor's or patient primary physician's discretion.
    Pacjent powróci do standardowego leczenia według uznania lekarza prowadzącego badanie lub lekarza pierwszego kontaktu pacjenta.
    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 Decision2022-05-07
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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