E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colite Ulcerosa |
|
E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colite Ulcerosa |
|
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 |
Study M16-067 comprises two sub-studies: The objective of Sub-Study 1 are to characterize the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC) and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC. |
La Sperimentazione M16-067 si articola in due sottostudi: L’obiettivo del Sottostudio 1 è quello di caratterizzare l’efficacia, la sicurezza ed il profilo di farmacocinetica di risankizumab come trattamento di induzione in soggetti affetti da colite ulcerosa in fase attiva di grado da moderato a grave, e identificare l’appropriata dose di induzione di risankizumab da sottoporre a ulteriore valutazione nell’ambito del Sottostudio 2. L’obiettivo del Sottostudio 2 è quello di valutare l’efficacia e la sicurezza di risankizumab rispetto a placebo nell’indurre la remissione clinica in soggetti affetti da colite ulcerosa in fase attiva di grado da moderato a grave. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations at the Baseline Visit. In addition for sub-study 2 only: Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit 2.Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline. 3. Active UC. 4.Demonstrated intolerance or inadequate response to one or more biologic therapies. |
1.Soggetti di ambo i sessi di età compresa fra = 18 e = 80 anni, età minima per il rilascio personale del consenso previsto per soggetti adulti in accordo alla normativa locale, alla Visita di Baseline.In aggiunta, ed esclusivamente per il Sottostudio 2: ove permesso a livello locale, soggetti di età = 16 e < 18 anni il cui sviluppo è classificato come Stadio 5 secondo Tanner alla visita di Baseline. 2.Diagnosi confermata di colite ulcerosa da almeno 3 mesi prima del Baseline. 3.Colite ulcerosa in fase attiva 4.Intolleranza o risposta inadeguata, confermate da evidenze, a una o più terapie biologiche. |
|
E.4 | Principal exclusion criteria |
1.Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation or ischemic colitis. 2.Subject receiving prohibited medications and treatment. 3.Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. 4.Subject with currently known complications of UC. |
1.Soggetto con diagnosi attuale di malattia di Crohn, malattia infiammatoria intestinale non classificata (IBD-U) oppure storia di colite da radioterapia oppure colite ischemica. 2.Soggetto in trattamento con farmaci e trattamenti controindicati. 3.Malattia infiammatoria che interessa esclusivamente il retto, secondo la valutazione endoscopica eseguita allo screening. 4.Soggetto con presenza nota di complicanze associate alla colite ulcerosa |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with clinical remission per Adapted Mayo score at Week 12 |
Percentuale di soggetti con remissione clinica in base al punteggio Adapted Mayo score alla Settimana 12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Proportion of subjects with endoscopic improvement at Week 12. 2. Proportion of subjects achieving clinical remission at Week 12 in subjects with a Full Mayo score of 6 to 12 at Baseline. 3. Proportion of subjects achieving clinical response at Week 12. 4. Proportion of subjects achieving clinical response at Week 4. 5. Proportion of subjects with endoscopic remission at Week 12. 6. Proportion of subjects with hospitalizations through Week 12. 7. Proportion of subjects with mucosal healing at Week 12. 8. Change from Baseline in UC-Symptom Questionnaire (UC-SQ) at Week 12. 9. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 12. 10. Change from Baseline in Short Form-36 at Week 12. 11. Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACITFatigue) at Week 12. 12. Proportion of subjects with UC-related surgeries through Week 12. |
1. Percentuale di soggetti con miglioramento endoscopico alla Settimana 12. 2. Percentuale di soggetti che ottengono la remissione clinica in base al punteggio completo Full Mayo score compreso fra 6 e 12 al Baseline. 3. Percentuale di soggetti che ottengono la risposta clinica alla Settimana 12. 4. Percentuale di soggetti che ottengono la risposta clinica alla Settimana 4. 5. Percentuale di soggetti con remissione endoscopica alla Settimana 12. 6. Percentuale di soggetti con ospedalizzazioni fino alla Settimana 12 compresa. 7. Percentuale di soggetti con guarigione della mucosa alla Settimana 12. 8. Variazione rispetto al Baseline del punteggio UC-SQ (UC-Symptom Questionnaire) alla Settimana 12. 9. Variazione rispetto al Baseline del punteggio IBDQ (Inflammatory Bowel Disease Questionnaire) alla Settimana 12. 10. Variazione rispetto al Baseline del punteggio Short Form-36 alla Settimana 12. 11. Variazione rispetto al Baseline del punteggio FACIT-Fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue) alla Settimana 12. 12. Percentuale di soggetti sottoposti a interventi chirurgici associati alla colite ulcerosa fino alla Settimana 12 compresa. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 12 2. Baseline, Week 12 3. Week 12 4. Week 4 5. Week 12 6. Week 12 7. Week 12 8. Baseline, Week 12 9. Baseline, Week 12 10. Baseline, Week 12 11. Baseline, Week 12 12. 12 weeks |
1. Settimana 12 2. Baseline, Settimana 12 3. Settimana 12 4. Settimana 4 5. Settimana 12 6. Settimana 12 7. Settimana 12 8. Baseline, Settimana 12 9. Baseline, Settimana 12 10. Baseline, Settimana 12 11. Baseline, Settimana 12 12. 12 Settimane |
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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 | 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) | Yes |
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 | 15 |
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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 265 |
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 |
Argentina |
Australia |
Austria |
Belarus |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
China |
Colombia |
Croatia |
Czechia |
Denmark |
Egypt |
France |
Germany |
Greece |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Slovakia |
Slovenia |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
Ukraine |
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
|
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | 1 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 1 |