E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic Dermatitis |
Dermatite atopica |
|
E.1.1.1 | Medical condition in easily understood language |
Atopic Dermatitis also named Eczema |
Dermatite atopica conosciuta anche come eczema |
|
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 |
|
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 |
To test the hypothesis that baricitinib is superior to placebo in the treatment of patients with moderate to severe atopic dermatitis. |
Testare l¿ipotesi che baricitinib sia superiore al placebo nel trattamento di pazienti con dermatite atopica da moderata a grave. |
|
E.2.2 | Secondary objectives of the trial |
To test the hypothesis that baricitinib is superior to placebo in the treatment of patients with moderate to severe atopic dermatitis. Improvements in signs and symptoms of atopic dermatitis. Improvements in patient-reported outcome measures.
|
Testare l¿ipotesi che baricitinib sia superiore al placebo nel trattamento di pazienti con dermatite atopica da moderata a grave.Miglioramenti di segni e sintomi della dermatite atopica. Miglioramenti delle misure di esito riferite dal paziente. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
At least 18 years of age. Have a diagnosis of AD at least 12 months prior to screening, as defined by the American Academy of Dermatology Have moderate to severe AD, including all of the following: a. Eczema Area and Severity Index (EASI) score =16 b. IGA score of =3 c. =10% of BSA involvement d. Have a documented history by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening, or history of intolerance to topical therapy. e. 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.
|
Almeno 18 anni di età. Avere una diagnosi di dermatite atopica almeno 12 mesi prima dello screening, come definito dall’Accademia Americana di Dermatologia Presentare DA da moderata a grave, comprendente tutti i sintomi seguenti: a. Indice di area e gravità dell’eczema (Eczema Area and Severity Index, EASI) con punteggio =16 b. Punteggio IGA pari a =3 c. Coinvolgimento della superficie corporea (BSA) pari al =10% d. Avere un’anamnesi documentata da un medico e/o da uno sperimentatore relativa a una risposta inadeguata ai farmaci topici esistenti entro 6 mesi prima dello screening, oppure un’anamnesi di intolleranza alla terapia topica. e. Essere pazienti di sesso maschile o di sesso femminile non gravide e non in allattamento. I pazienti di sesso maschile e femminile potenzialmente fertili devono acconsentire a utilizzare un metodo anticoncezionale affidabile durante lo studio e per almeno 4 settimane dopo l’ultima dose di farmaco sperimentale. |
|
E.4 | Principal exclusion criteria |
Have other concomitant skin conditions that would interfere with evaluations of the effect of study medication Are currently experiencing or have a history of erythrodermic, refractory, or unstable skin disease that requires frequent hospitalizations and/or intravenous treatment for skin infections that may interfere with participation in the study. Skin infection that requires treatment with topical or systemic antibiotics. Serious concomitant illness Are immunocompromised and at an unacceptable risk for participating in the study. Have a clinically serious viral, bacterial, fungal, or parasitic infection Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study. Have evidence of active TB or latent TB Have evidence of HBV, HCV or HIV infection
|
Presentare altre condizioni cutanee concomitanti che potrebbero interferire con le valutazioni dell’effetto dello studio. Manifestare al momento attuale o presentare un’anamnesi di patologia cutanea eritrodermica, refrattaria o instabile che richieda frequenti ricoveri ospedalieri e/o trattamento endovenoso per infezioni cutanee che potrebbero interferire con la partecipazione allo studio. Infezione cutanea che richiede trattamento con antibiotici topici e sistemici. Malattia concomitante grave Essere immunocompromessi e presentare un rischio inaccettabile per la partecipazione allo studio. Presentare un’infezione batterica, micotica o parassitica clinicamente grave. Essere stati esposti a un vaccino vivo nelle 12 settimane prima della randomizzazione pianificata o prevedere di necessitare/ricevere un vaccino vivo durante il corso dello studio. Presentare evidenza di TB attiva o latente Presentare evidenza di infezione da HBV, HCV o HIV |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients achieving IGA of 0 or 1 with a =2-point improvement. |
Percentuale di pazienti che raggiungono il punteggio IGA pari a 0 o 1 con un miglioramento di =2 punti. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Proportion of patients achieving EASI75 2. Proportion of patients achieving EASI90 3. Percent change from baseline in EASI score 4. Proportion of patients achieving SCORAD75 5. Mean change from baseline in the score of Item 2 of the ADSS 6. Mean change from baseline in Skin Pain NRS 7. Proportions of patients achieving a 4-point improvement in Itch NRS |
1. Percentuale di pazienti che raggiungono il punteggio EASI75 2. Percentuale di pazienti che raggiungono il punteggio EASI90 3. Percentuale di variazione dal basale del punteggio EASI 4. Percentuale di pazienti che raggiungono il punteggio SCORAD75 5. Variazione media dal basale nel punteggio della voce 2 del ADSS 6. Variazione media dal basale del dolore cutaneo secondo l¿indice NRS 7. Percentuale di pazienti che raggiungono un miglioramento di 4 punti sul punteggio NRS |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Endpoint 1 to 6 only at week 16 Endpoint 7 at week 1, week 2, week 4 and week 16 |
Da 1 al 6 solo alla settimana 16; 7 alla settimana 1, settimana 2, settimana 4 e settimana 16 |
|
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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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 |
Canada |
India |
Japan |
Mexico |
Russian Federation |
Taiwan |
United States |
Denmark |
France |
Germany |
Italy |
Czechia |
|
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
|
LVLS: End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient. |
La fine dello studio ¿ definita come la data dell'ultima visita (LVLS) o l'ultima procedura programmate riportata nella Schedule of Activities per l'ultimo paziente come delineato nel protocollo |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |