E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colite Ulcerosa |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colite Ulcerosa |
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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 |
Study M16-066 comprises three sub-studies: Sub-study 1: Randomized, double-blind, placebo-controlled maintenance To evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active ulcerative colitis (UC) who responded to IV risankizumab induction treatment in Study M16-067 or Study M16-065. Sub-study 2: Randomized, exploratory maintenance To evaluate the efficacy and safety of two different dosing regimens for risankizumab (therapeutic drug monitoring vs clinical assessment for dose escalation) as maintenance therapy in subjects with moderately to severely active UC who responded to induction treatment in Study M16-067 or Study M16-065. Sub-study 3: Open-label long term extension To evaluate long-term safety of risankizumab in subjects who completed Sub-study 1 or 2. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab.
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M16-066 prevede 3 Sottostudi: 1:Sottustudio di mantenimento randomizzato, in doppio cieco e controllato verso placebo. Valutare l’efficacia e la sicurezza di RISA rispetto a placebo come terapia di mantenimento in soggetti affetti da CU in fase attiva di grado da moderato a grave che hanno risposto al trattamento di induzione con RISA EV nell’ambito di M16-067 o di M16-065. 2: Sottostudio di mantenimento randomizzato ed esplorativo. Valutare l’efficacia e la sicurezza di 2 diversi regimi di dosaggio per RISA quale terapia di mantenimento in soggetti affetti da CU in fase attiva di grado da moderato a grave che hanno presentato risposta al trattamento di induzione nell’ambito di M16-067 o di M16-065. 3: Sottostudio di estensione in aperto a lungo termine Valutare la sicurezza a lungo termine di RISA in soggetti che hanno completato il Sottostudio 1 o 2. Verrà inoltre esplorata l’efficacia e la tollerabilità a lungo termine di RISA come obiettivo aggiuntivo
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Entry and completion of Study M16-067 or Study M16-065. Completion includes the final endoscopy of Study M16-067 or Study M16-065.
Achieved clinical response at the last visit of Study M16-067 or Study M16-065. |
Arruolamento e completamento della partecipazione alla Sperimentazione M16-067 o M16-065. Per completamento si intende anche l’esecuzione dell’endoscopia finale nell’ambito della Sperimentazione M16-067 o M16-065.
Ottenimento della risposta clinica in occasione dell’ultima visita della Sperimentazione M16-067 o M16-065. |
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E.4 | Principal exclusion criteria |
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 or Study M16-065 that in the Investigator's judgment makes the subject unsuitable for this study.
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Soggetto che per qualsiasi motivo non è considerato idoneo alla sperimentazione da parte dello sperimentatore.
Soggetto con nota ipersensibilità a risankizumab oppure agli eccipienti di uno qualsiasi fra i medicinali sperimentali o agli ingredienti a base di CHO oppure con evento avverso insorto durante la Sperimentazione M16-067 o M16-065 che a giudizio dello sperimentatore rende il soggetto non idoneo a partecipare alla presente sperimentazione. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sub-study 1 or 2 : Proportion of subjects with clinical remission per Adapted Mayo score at Week 52. Sub-study 3: Evaluation of long-term safety
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1 o 2: Percentuale di soggetti con remissione clinica in base al punteggio Adapted Mayo score alla Settimana 52. Sottostudio 3: valutazione della sicurezza a lungo termine
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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. Proportion of subjects with endoscopic improvement at Week 52. 2. Proportion of subjects achieving clinical remission per Full Mayo score at Week 52. 3. Proportion of subjects with steroid-free remission at Week 52. 4. Proportion of subjects with sustained clinical remission per Adapted Mayo score at Week 52. 5. Proportion of subjects who discontinued corticosteroid use at Week 52. 6. Proportion of subjects with sustained endoscopic improvement at Week 52. 7. Proportion of subjects with clinical response per Adapted Mayo score at Week 52. 8. Proportion of subjects with endoscopic remission at Week 52. 9. Proportion of subjects with hospitalizations through Week 52. 10. Change from Baseline in UC-Symptom Questionnaire (UCSQ) at Week 52. 11. Proportion of subjects with histologic remission at Week 52. 12. Proportion of subjects with mucosal healing at Week 52. 13. Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 52. 14. Proportion of subjects with UC-related surgeries through Week 52. 15. Change from Baseline in Short Form-36 at Week 52. 16. Change from Baseline in FACIT-Fatigue at Week 52
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1. Percentuale di soggetti con miglioramento endoscopico alla Settimana 52 2. Percentuale di soggetti con remissione clinica in base al punteggio completo Full Mayo score alla Settimana 52. 3. Percentuale di soggetti che hanno interrotto l’uso di corticosteroidi alla Settimana 52. 4. Percentuale di soggetti con remissione clinica in base al punteggio Adapted Mayo score alla Settimana 52. 5. Percentuale di soggetti che hanno interrotto l’utilizzo di corticosteroidi alla Settimana 52. 6. Percentuale di soggetti con miglioramento endoscopico alla Settimana 52. 7. Percentuale di soggetti con risposta clinica in base al punteggio Adapted Mayo score alla Settimana 52. 8. Percentuale di soggetti con remissione endoscopica alla Settimana 52 9. Percentuale di soggetti con ospedalizzazioni fino alla Settimana 52 compresa 10. Variazione rispetto alla Settimana 0 del punteggio UC-SQ (UC-Symptom Questionnaire) alla Settimana 52. 11. Percentuale di soggetti con remissione istologica alla Settimana 52 12. Percentuale di soggetti con guarigione della mucosa alla Settimana 52 13. Variazione rispetto alla Settimana 0 del punteggio IBDQ (Inflammatory Bowel Disease Questionnaire) rilevato alla Settimana 52 14. Percentuale di soggetti sottoposti a interventi chirurgici associati alla colite ulcerosa fino alla Settimana 52 compresa 15. Variazione rispetto alla Settimana 0 nel punteggio Short Form-36 rilevato alla Settimana 52 16. Variazione rispetto alla Settimana 0 nel punteggio FACIT-Fatigue rilevato 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 | 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 | Yes |
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 | 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 |
South Africa |
Spain |
Sweden |
Switzerland |
Taiwan |
Turkey |
Ukraine |
United Kingdom |
United States |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 5 |