E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Ulcerative Colitis |
Colite ulcerosa ad attività moderata-severa |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of Digestive Tract |
Infiammazione del tratto digestivo |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 evaluate the efficacy and safety of guselkumab in moderately to severely active UC. |
Valutare l’efficacia e la sicurezza di guselkumab in pazienti con Colite Ulcerosa ad attività moderata-severa |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the impact of guselkumab on health-related quality of life (HRQoL) and health economics outcome measures. • To evaluate the PK, immunogenicity, and pharmacodynamics (PD) of guselkumab therapy, including changes in C-reactive protein (CRP) and fecal calprotectin. |
• Valutare l’impatto di guselkumab sulle misure degli esiti relativi alla HRQoL e all’economia sanitaria. • Valutare la PK, l’immunogenicità e la PD della terapia con guselkumab, considerando anche le variazioni della PCR e della calprotectina fecale. |
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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 |
Pharmacogenomics Version: iniziale (dettagli inclusi nel protocollo di studio principale) Date: 29/05/2019 Title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis Objectives: Genetic (DNA) analyses will be conducted only in participants who sign the consent form to participate in the pharmacogenomic substudy. These analyses are considered exploratory and will be summarized in a separate technical report.
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Farmacogenomica Versione: iniziale (dettagli inclusi nel protocollo di studio principale) Data: 29/05/2019 Titolo: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis Obiettivi: Le analisi genetiche (DNA) saranno condotte soltanto nei partecipanti che firmeranno il modulo di consenso per partecipare al sottostudio di farmacogenomica. Queste analisi sono considerate esplorative e saranno sintetizzate in una relazione tecnica separata.
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E.3 | Principal inclusion criteria |
1. Male or female, 18 years of age or older 2. Documented diagnosis of UC at least 3 months before screening 3. Moderately to severely active UC as defined by baseline modified Mayo score 4. History of inadequate response to or failure to tolerate conventional or advanced therapy as defined in the protocol 5. Screening laboratory test results within the study protocol defined parameters Please see section 5.1 in the protocol for all inclusion criteria. |
1. Uomini o donne di età pari o superiore a 18 anni. 2. Diagnosi documentata di CU almeno 3 mesi prima dello screening. 3. CU ad attività moderata-severa, definita come un punteggio Mayo modificato basale. 4. Storia di risposta inadeguata o intorreranza alla terapia convenzionale o avanzata come definito nel protocollo 5. risultati dei test di laboratorio allo screening entro i paramentri definiti dal protocollo di studio
Si prega di consultare la sezione 5.1 del protocollo per tutti i criteri di inclusione. |
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E.4 | Principal exclusion criteria |
1.Severe extensive colitis as defined in the study protocol 2.UC limited to the rectum only 3. Presence of a stoma 4. Presence or history of a fistula 5.Presence of symptomatic colonic or small bowel obstruction 6. History of extensive colonic resection 7.History of colonic mucosal dysplasia 8. Indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease.
Please see section 5.2 in the protocol for all exclusion criteria. |
1.Colite estesa grave come definita nel protocollo di studio 2.Colite ulcerosa limitata al solo retto 3. Presenza di stoma 4. Presenza o storia di una fistola 5.Presenza di ostruzione sintomatica del colon o dell’intestino tenue 6. Storia di resezione estesa del colon 7. Storia di displasia della mucosa del colon 8. Diagnosi di colite indefinita, colite microscopica, colite ischemica o malattia di Crohn o reperti clinici indicativi della malattia di Crohn
Si prega di consultare la sezione 5.2 del protocollo per tutti i criteri di esclusione. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Induction study 1: Clinical response at Week 12 2. Induction study 2: Clinical remission at Week 12 3. Maintenance study1. Clinical remission at Week 44 |
1. Studio di induzione 1: Risposta clinica a settimana 12 2. Studio di induzione 2: Remissione clinica a settimana 12 3. Studio di mantenimento:Remissione clinica a settimana 44 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
point 1- 2 week 12 point 3 week 52 |
punto 1-2 settimana 12 punto 3 settimana 52 |
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E.5.2 | Secondary end point(s) |
Symptomatic remission at Week 44; Endoscopic healing at Week 44; Corticosteroid-free clinical remission at Week 44; Clinical response at Week 44; Histologic-endoscopic mucosal healing at Week 44; Clinical remission at Week 44among the participants who had achieved clinical remission at maintenance baseline; Endoscopic normalization at Week M-44 |
Remissione sintomatica alla Settimana M-44; Guarigione endoscopica alla Settimana M-44; Remissione clinica senza corticosteroidi alla Settimana M-44.; Risposta clinica alla Settimana M-44.; Guarigione istologico-endoscopica mucosale alla Settimana M-44.; Remissione clinica alla Settimana M-44tra i partecipanti che avevano ottenuto la remissione clinica al basale del mantenimento; Normalizzazione endoscopia a settimana 44 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
week 44; week 44; week 44; week 44; week 44; week 44; weeks 44 |
settimana 44; settimana 44; settimana 44; settimana 44; settimana 44; settimana 44; settimana 44 |
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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 | 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 | 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 | 6 |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 103 |
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 |
China |
Hong Kong |
Israel |
Japan |
Korea, Republic of |
Malaysia |
Russian Federation |
Taiwan |
Turkey |
Ukraine |
United States |
Belgium |
Bulgaria |
France |
Germany |
Hungary |
Italy |
Netherlands |
Poland |
Portugal |
Spain |
Sweden |
United Kingdom |
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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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 | 22 |
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 | 22 |