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 |
|
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 evaluate the efficacy of tralokinumab compared with placebo in treating moderate-to-severe Atopic dermatitis.
|
Valutare l'efficacia di tralokinumab rispetto al placebo nel trattamento della DA da moderata a severa. |
|
E.2.2 | Secondary objectives of the trial |
During the initial treatment period: - To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.
During the maintenance treatment period: - To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at 16 weeks.
|
Obiettivi secondari: Valutare l'efficacia di tralokinumab rispetto al placebo per la gravità e l'estensione della DA e per la qualità della vita correlata alla salute. Obiettivo di mantenimento: Valutare il mantenimento dell'effetto con la somministrazione continuata di tralokinumab fino a 52 settimane rispetto al placebo nei soggetti che conseguono una risposta clinica alla Settimana 16. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age 18 and above • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD. • Diagnosis of AD for =1 year. • Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable. • AD involvement of =10% body surface area at screening and baseline. • An EASI score of =12 at screening and 16 at baseline. • An IGA score of =3 at screening and at baseline. • A Worst Daily Pruritus numeric rating scale (NRS) average score of =4 during the week prior to baseline. • Stable dose of emollient twice daily for at least 14 days before randomisation.
|
•Età pari o superiore a 18 anni. •Diagnosi di DA definita dai criteri di Hanifin e Rajka (1980) per la DA. •Diagnosi di DA da =1 anno. •Soggetti con anamnesi recente di risposta inadeguata al trattamento confarmaci topici o per i quali i trattamenti topici siano altrimentisconsigliati dal punto di vista medico. •Estensione della DA su =10% della superficie corporea allo screening e al basale. •Punteggio EASI =12 allo screening e 16 al basale. •Punteggio IGA =3 allo screening e al basale. •Punteggio medio =4 sulla scala di valutazione numerica (NRS, numericrating scale) Worst Daily Pruritus (peggior prurito giornaliero) durantela settimana precedente al basale. •Dose stabile di emolliente due volte al giorno per almeno 14 giorniprima della randomizzazione. |
|
E.4 | Principal exclusion criteria |
• Active dermatologic conditions that may confound the diagnosis of AD.
• Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
• Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
• Treatment with TCS and/or TCI within 2 weeks prior to randomisation.
• Active skin infection within 1 week prior to randomisation.
• Clinically significant infection within 4 weeks prior to randomisation.
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
• Tuberculosis requiring treatment within the 12 months prior to screening.
• Known primary immunodeficiency disorder.
|
•Condizioni dermatologiche attive che potrebbero confondere ladiagnosi di DA. •Uso di lettini abbronzanti o fototerapia nelle 6 settimane precedenti allarandomizzazione. •Trattamento con farmaci immunosoppressori/immunomodulantisistemici e/o corticosteroidi sistemici nelle 4 settimane precedenti allarandomizzazione. •Trattamento con corticosteroidi topici e/o inibitori topici dellacalcineurina nelle 2 settimane precedenti alla randomizzazione. •Infezione cutanea attiva nella settimana precedente allarandomizzazione. •Infezione clinicamente significativa nelle 4 settimane precedenti allarandomizzazione. •Infezione parassitaria da elminti nei 6 mesi precedenti alla data dellafirma del consenso informato. •Tubercolosi che richieda trattamento nei 12 mesi precedenti alloscreening. •Disturbo accertato da immunodeficienza primaria. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
For the initial treatment period: - IGA score of 0 (clear) or 1 (almost clear) at Week 16 - EASI75 at Week 16 |
Per il periodo iniziale di trattamento: -Punteggio IGA di 0 (clear) o 1 (almost clear) alla Settimana 16. -EASI75 alla Settimana 16. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Bi-weekly throughout study. |
Bi-settimanalmente per tutto lo studio |
|
E.5.2 | Secondary end point(s) |
For the initial treatment period: Severity and extent of AD: Change in SCORAD from baseline to Week 16 Itch: Reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 from baseline to Week 16. Quality of life: Change in DLQI score from baseline to Week 16 For the maintenance treatment period: IGA of 0/1 at Week 52 among subjects with IGA of 0/1 at Week 16 after initial randomisation to tralokinumab EASI75 at Week 52 among subjects with EASI75 at Week 16 after initial randomisation to tralokinumab |
Per il periodo inizial edi trattamento: •Variazione del punteggio SCORAD dal basale alla Settimana 16. •Riduzione del punteggio Worst Daily Pruritus NRS (mediasettimanale) di almeno 4 punti dal basale alla Settimana 16. •Variazione del punteggio DLQI dal basale alla Settimana 16. Per il periodo di trattamento: •IGA di 0/1 alla Settimana 52 tra i soggetti con IGA di 0/1 allaSettimana 16 dopo la randomizzazione iniziale a tralokinumab. •EASI75 alla Settimana 52 tra i soggetti con EASI75 alla Settimana 16dopo la randomizzazione iniziale a tralokinumab. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Bi-weekly throughout study for assessment conducted by the HCP. For Puritus the assessment is done on a daily basis using an eDiary. For DLQI completed by the subject every 2, 4 or 8 weeks. |
Bi-settimanalmente per tutto lo studio per la valutazione condotta dall'HPC. Per il prurito la valutazione viene effettuata quotidianamente utilizzando un eDiary. Per il DLQI viene completato dal soggetto ogni 2, 4 o 8 settimane. |
|
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 | No |
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 | 5 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Canada |
Denmark |
Italy |
Korea, Republic of |
Poland |
Russian Federation |
United Kingdom |
United States |
|
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
|
last visit of the last subject undergoing the trial |
Ultima visita dell'ultimo soggetto coinvolto nello studio |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |