E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Ulcerative Colitis |
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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] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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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 determine the effect of vedolizumab IV compared to adalimumab SC on clinical remission at Week 52. |
Determinare l¿effetto di vedolizumab EV rispetto ad adalimumab SC sulla remissione clinica alla Settimana 52. |
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E.2.2 | Secondary objectives of the trial |
¿ To evaluate the effect of vedolizumab IV compared to adalimumab SC on mucosal healing at Week 52. ¿ To evaluate the effect of vedolizumab IV compared to adalimumab SC on corticosteroid-free remission at Week 52. |
Valutare l¿effetto di vedolizumab EV rispetto ad adalimumab SC sulla guarigione mucosale alla Settimana 52. Valutare l¿effetto di vedolizumab EV rispetto ad adalimumab SC sulla remissione libera da corticosteroidi alla Settimana 52.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The subject has a diagnosis of UC established at least 6 months prior to enrollment, by clinical and endoscopic evidence and corroborated by a histopathology report. The subject has moderately to severely active UC as determined by a complete Mayo score of 6-12 with an endoscopic subscore =2 within 14 days prior to randomization. The subject has evidence of UC extending proximal to the rectum (=15 cm of involved colon). The subject has had previous treatment with tumor necrosis factor–alpha (TNF-a) antagonists without documented clinical response to treatment or the subject is naïve to TNF-a antagonist therapy but is failing current conventional treatment.
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Soggetto con diagnosi di CU stabilita almeno 6 mesi prima dell’arruolamento in base all’evidenza clinica ed endoscopica e corroborata da un referto istopatologico. Soggetto con CU attiva da moderata a grave in base a un punteggio Mayo completo di 6-12, con un sottopunteggio endoscopico =2 nei 14 giorni precedenti la randomizzazione. Soggetto con evidenza di CU che si estende in prossimità del retto (=15 cm di colon interessato). Soggetto sottoposto a pregresso trattamento con antagonisti del fattore di necrosi tumorale alfa (tumor necrosis factor–alpha, TNF-a) senza risposta clinica documentata al trattamento oppure soggetto naïve alla terapia con antagonisti del TNF-a che non risponde alla terapia convenzionale attualmente in corso.
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E.4 | Principal exclusion criteria |
The subject has had extensive colonic resection, subtotal or total colectomy. The subject has any evidence of an active infection during Screening. The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective checklist before the administration of study drug. The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half lives prior to screening (whichever is longer). The subject has had prior exposure to vedolizumab, natalizumab, efalizumab, adalimumab or rituximab.
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Soggetto che è stato sottoposto a resezione estesa del colon, colectomia subtotale o colectomia totale. Soggetto che mostra qualsiasi evidenza di infezione attiva durante lo screening. Soggetto con elenco di controllo soggettivo per la leucoencefalopatia multifocale progressiva (LMP) positivo prima della somministrazione del farmaco dello studio. Soggetto che ha ricevuto qualsiasi agente biologico o biosimilare sperimentale o approvato nei 60 giorni o nelle 5 emivite dell’agente precedenti lo screening (a seconda di quale sia il periodo più lungo). Soggetto che è stato esposto precedentemente a vedolizumab, natalizumab, efalizumab, adalimumab o rituximab
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving clinical remission (defined as a complete Mayo score of =2 points and no individual subscore >1 point) at Week 52. |
L’endpoint primario dello studio è la percentuale di soggetti che ottiene una remissione clinica (definita come punteggio Mayo completo =2 punti e nessun sottopunteggio individuale >1 punto) alla Settimana 52. |
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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) |
¿ Proportion of subjects achieving mucosal healing (defined as Mayo endoscopic subscore =1 point) at Week 52. ¿ Proportion of subjects using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at Week 52.
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¿ Percentuale di soggetti che ottiene la guarigione mucosale (definita come sottopunteggio endoscopico Mayo =1 punto) alla Settimana 52. ¿ Percentuale di soggetti in trattamento con corticosteroidi orali al basale che ha interrotto i corticosteroidi ed ¿ in remissione clinica alla Settimana 52.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
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 | Yes |
E.7.1.3.1 | Other trial type description |
Therapeutic confirmatory |
Conferma terapeutica |
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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 | No |
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 | 2 |
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 140 |
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 |
Bosnia and Herzegovina |
Canada |
Chile |
Colombia |
Hong Kong |
Israel |
Korea, Republic of |
Mexico |
Russian Federation |
Serbia |
Taiwan |
Turkey |
Ukraine |
United States |
Belgium |
Bulgaria |
Croatia |
Denmark |
Estonia |
France |
Germany |
Hungary |
Italy |
Latvia |
Lithuania |
Netherlands |
Poland |
Portugal |
Romania |
Slovakia |
Spain |
United Kingdom |
Czechia |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |