E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis |
Dermatite Atopica |
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E.1.1.1 | Medical condition in easily understood language |
Atopic dermatitis also known as Eczema |
Dermatite atopica conosciuta anche come eczema |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this long term extention trial is to estimate the effect of long term therapy with baricitinib on responders and partial responders at entry of JAHN.
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L¿obiettivo primario di questa sperimentazione di estensione a lungo termine ¿ quello di valutare l¿effetto della terapia a lungo termine con baricitinib sui responder e sui responder parziali all¿ingresso nello studio JAHN. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of increasing or maintaining baricitinib dose on clinical measures and patient reported outcomes. To evaluate the effect of starting baricitinib on clinical measures and patient reported outcomes. To evaluate the effect of maintaining baricitinib dose on clinical measures. |
Valutare l¿effetto dell¿aumento o del mantenimento della dose di baricitinib sulle misure cliniche e sugli esiti riferiti dal paziente. Valutare l¿effetto dell¿inizio dell¿assunzione di baricitinib sulle misure cliniche e sugli esiti riferiti dal paziente. Valutare l¿effetto del mantenimento della dose di baricitinib sulle misure cliniche. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies Specify title, date and version of each substudy with relative objectives: Study JAHN will evaluate the effect of stopping or decreasing the dose of baricitinib in the context of a randomized treatment withdrawal and downtitration substudy starting at Week 52. Objectives: To evaluate the change in clinical response after treatment withdrawal or down titration. To evaluate for patients retreated during substudy the ability to recapture efficacy based on clinical measures after experiencing a loss of treatment benefit.
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Lo studio JAHN valuter¿ l¿effetto a seguito dell¿interruzione o della diminuzione della dose di baricitinib nel contesto di un sottostudio che prevede il ritiro randomizzato dal trattamento e una riduzione graduale della dose a partire dalla settimana 52. Obiettivi: Valutare il cambiamento della risposta clinica dopo il ritiro dal trattamento o la riduzione graduale della dose. Per i pazienti sottoposti nuovamente a trattamento durante il sottostudio, valutare la capacit¿ di recuperare l¿efficacia sulla base delle misure cliniche, dopo avere manifestato una perdita di beneficio del trattamento.
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E.3 | Principal inclusion criteria |
- Have completed the final active treatment visit for an originator study (such as JAHL or JAHM) - Are male or nonpregnant, nonbreastfeeding female patients. - Male patients, and female patients of childbearing potential, must agree to use a reliable method of birth control during the study and for at least 4 weeks following the last dose of investigational product.
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- Avere completato la visita finale del trattamento attivo per uno studio di origine (come JAHL or JAHM) - Essere un paziente di sesso maschile, oppure di sesso femminile non gravida, non in allattamento. - I pazienti di sesso maschile o femminile potenzialmente fertili devono acconsentire a utilizzare un metodo anticoncezionale affidabile durante lo studio e per almeno 4 settimane dopo l’ultima dose di prodotto sperimentale. |
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E.4 | Principal exclusion criteria |
- Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient if IP continues to be administered. - Had IP permanently discontinued at any time during a previous baricitinib study, except for patients who had IP discontinued during originating study due to rescue with an oral systemic AD therapy (e.g., corticosteroid, cyclosporine, methotrexate) - Had temporary IP interruption continue at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the study. |
- Presentare disturbi non controllati a livello cerebro-cardiovascolare, respiratorio, epatico, renale, gastrointestinale, endocrino, ematologico, neuropsichiatrico, oppure valori di laboratorio anomali sviluppati durante un precedente studio su baricitinib che, nell’opinione dello sperimentatore, pongono il paziente a un rischio non accettabile se IP continua a essere somministrato. - Avere sospeso in modo permanente PS in qualsiasi momento durante un precedente studio su baricitinib, fatta eccezione per i pazienti che hanno interrotto IP durante lo studio di origine, a causa di un intervento di emergenza con una terapia orale sistemica per la DA (per es. corticosteroidi, ciclosporina, metotrexato) - Avere avuto un’interruzione temporanea di PS e continuarla alla visita finale dello studio di uno studio precedente su baricitinib e, nell’opinione dello sperimentatore, ciò ponga un rischio inaccettabile per la partecipazione del paziente allo studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients with a response of IGA 0 or 1 |
Percentuale di pazienti che raggiungono il punteggio IGA pari a 0 o 1 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
16, 36 and 52 weeks after re-randomization of feeder trial |
16, 36 e 52 settimane dopo la nuova randomizzazione della sperimentazione originaria |
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E.5.2 | Secondary end point(s) |
1. Proportion of patients with a response of IGA 0, 1, or 2 2. Proportion of patients achieving response of EASI75 from baseline of originating study 3. Proportion of patients with a 4-point improvement in Itch NRS from baseline of originating study 4. Proportion of patients with a response of IGA 0 or 1 |
1. Percentuale di pazienti che raggiungono il punteggio IGA pari a 0, 1 o 2 2. Percentuale di pazienti che raggiungono il punteggio EASI75 dal basale dello studio di origine 3. Percentuale di pazienti che raggiungono un miglioramento di 4 punti nel prurito sul punteggio NRS dal basale dello studio di origine 4. Percentuale di pazienti che raggiungono il punteggio IGA pari a 0 o 1
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 and 2: assessed at Weeks 16, 36, and 52 3: assessed at week 16 4: assessed at Weeks 16, 36, and 52 (nonresponders) |
1 e 2: valutato alle settimane 16, 36 e 52 3: valutato alla settimana 16 4: valutato alla settimana 16, 36 e 52 (non responders) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 83 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
India |
Israel |
Japan |
Korea, Democratic People's Republic of |
Korea, Republic of |
Mexico |
Taiwan |
Austria |
Denmark |
France |
Germany |
Hungary |
Italy |
Poland |
Spain |
Switzerland |
Czechia |
Argentina |
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E.8.7 | Trial 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
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The End of the trial is definde as the date of the last visit (LVLS) or last scheduled procedure shown in the Schedule of Activities for the last patient as outlined in the protocol. |
La fine dello studio ¿ definita come la data dell'ultima visita (LVLS) o l'ultima procedura programmata riportata nella Schedule of Activities per l'ultimo paziente come delineato nel protocollo. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 11 |