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 |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012438 |
E.1.2 | Term | Dermatitis atopic |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
To evaluate the long-term safety of tralokinumab |
Valutare la sicurezza a lungo termine di tralokinumab |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of tralokinumab given as continuous treatment, re-treatment, or introduced for the first time in tralokinumab naïve subjects |
Valutare l'efficacia di tralokinumab somministrato come trattamento continuo, come ritrattamento o introdotto per la prima volta in soggetti naïve a tralokinumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1334, -1339, -1341 or -1342. -Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator. -Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial). -Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline. |
• Completamento del periodo o dei periodi di trattamento in uno degli studi originari: LP0162-1325, -1326, -1334, -1339, -1341 o -1342. • Compliance al protocollo dello studio clinico nello studio originario, con soddisfazione dello sperimentatore. • Capacità e volontà di auto-somministrarsi il trattamento con tralokinumab (o di farselo somministrate da una persona che presta le cure) a casa dopo le 3 visite di iniezione iniziali al centro dello studio (in questo studio). • Dose stabile di emolliente due volte al giorno (o più spesso, se necessario) per almeno 14 giorni prima del basale. |
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E.4 | Principal exclusion criteria |
-Any condition that required permanent discontinuation of trial treatment in the parent trial. -More than 26 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial (to be assessed at baseline). -Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject. -Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable safety risk for the subject. -Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline. -Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline. -Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational biologic agents: o Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline. -Clinically significant infection within 4 weeks prior to baseline. -A helminth parasitic infection within 6 months prior to the date when informed consent is obtained. -Tuberculosis requiring treatment within 12 months prior to screening. - Known primary immunodeficiency disorder. |
• Qualsiasi disturbo che abbia richiesto la sospensione permanente del trattamento dello studio nello studio originario. • Più di 26 settimane trascorse da quando il soggetto ha ricevuto l'ultima iniezione di medicinale sperimentale (IMP) nello studio originario (da valutare al basale). • Soggetti che, durante la loro partecipazione allo studio originario, hanno sviluppato un evento avverso grave (SAE) ritenuto correlato a tralokinumab dallo sperimentatore e che, secondo il parere dello sperimentatore, potrebbe indicare che il proseguimento del trattamento con tralokinumab potrebbe presentare un rischio di sicurezza non giustificato per il soggetto. • Soggetti che, durante la loro partecipazione allo studio originario, hanno sviluppato un evento avverso (AE) ritenuto correlato a tralokinumab dallo sperimentatore, che ha determinato la sospensione temporanea del trattamento dello studio e che, secondo il parere dello sperimentatore, potrebbe indicare che il proseguimento del trattamento con tralokinumab potrebbe presentare un rischio di sicurezza non giustificato per il soggetto. • Trattamento con farmaci immunosoppressori/immunomodulatori sistemici e/o corticosteroidi sistemici nelle 4 settimane precedenti al basale. • Trattamento con inibitori topici della fosfodiesterasi 4 nelle 2 settimane precedenti al basale. • Assunzione di qualsiasi terapia biologica in commercio (ovvero immunoglobulina o anti-immunoglobulina E) incluso dupilumab o di agenti biologici sperimentali: o Qualsiasi agente di deplezione delle cellule, tra cui rituximab: nei 6 mesi precedenti al basale o fino a che la conta linfocitaria non sia ritornata alla normalità, a seconda di quale sia il periodo più lungo. o Altri biologici: nei 3 mesi o nelle 5 emivite, a seconda di quale sia il periodo più lungo, precedenti al basale. • Infezione clinicamente significativa nelle 4 settimane precedenti al basale. • Infezione parassitaria da elminti nei 6 mesi precedenti alla data della firma del consenso informato. • Tubercolosi che abbia richiesto trattamento nei 12 mesi precedenti allo screening. • Disturbo accertato da immunodeficienza primaria. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of adverse events (AEs) from baseline through the last treatment visit (up to Week 142)
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Numero di eventi avversi (AE) dal basale fino all'ultima visita di trattamento (fino alla Settimana 142) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) IGA score of 0 (clear) or 1 (almost clear) at Weeks 16, 56, 80, 104, 128 and 142. 2) EASI75 at Weeks 16, 56, 80, 104, and 128 |
1) Punteggio Investigator Global Assessment (IGA, valutazione globale dello sperimentatore)1 di 0 (cute intatta) o 1 (cute pressoché intatta) alle Settimane 16, 56, 80, 104 e 128 2) Riduzione di almeno il 75% dell'Eczema Area and Severity Index (EASI75, indice di area e gravità dell'eczema)2 rispetto al basale nello studio originario, alle Settimane 16, 56, 80, 104 e 128 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Weeks 16, 56, 80, 104, and 128. 2) Weeks 16, 56, 80, 104, and 128.
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1) Settimane 16, 56, 80, 104 e 128. 2) Settimane 16, 56, 80, 104 e 128. |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
estensione a lungo termine, in aperto, a singolo braccio, multicentrico |
An open-label, single-arm, multi-centre, long-term extension trial |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 135 |
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 |
Japan |
United States |
Belgium |
Czechia |
France |
Germany |
Italy |
Poland |
Spain |
United Kingdom |
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E.8.7 | Trial 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
|
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 15 |