E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colitis Ulcerosa |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colitis Ulcerosa |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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. |
El estudio M16-066 comprende tres subestudios: Subestudio 1: Randomizado, dobleciego, controlado con placebo, de mtto. Evaluar la efi y seguridad de risankizumab v placebo, como terapia de mtto en pacientes con (CU) de moderada a severa y que han respondido al tto de inducción con risankizumab en los estudios M16-067 o M16-065. Sub-estudio 2: Randomizado, exploratorio de mtto. Evaluar la eficacia y seguridad de dos regímenes de dosificación diferentes para risankizumab (monitorización de medicación terapéutica vs evaluación clínica para el aumento de dosis) como terapia de mtto en suj con colitis ulcerosa (CU) de moderada a severa activa y que hayan respondido al tto de inducción en el estudio M16-067 o en el estudio M16-065. Sub-estudio 3: Estudio abierto de ext. Evaluar la seguridad a largo plazo de risankizumab en pacientes que hayan completado los subestudios 1 o 2. Otros obj ad son investigar la eficacia a largo plazo y la tolerabilidad de risankizumab. |
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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. |
La entrada y finalización del Estudio M16-067 o Estudio M16-065. La finalización incluye la endoscopia final del Estudio M16-067 o del Estudio M16-065. Alcanzar respuesta clínica en la última visita de los estudios 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. |
El sujeto a criterio del médico investigador, por cualquier razón, se considera un candidato inadecuado para el estudio. El sujeto tiene hipersensibilidad a risankizumab, a algún excipiente de la medicación de tratamiento, a ingredientes de CHO o sufre una reacción adversa durante los estudios M16-067 o M16-065 que a criterio del investigador hace al sujeto inadecuado para el estudio. |
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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 |
Sub-estudios 1 o 2 : Proporción de sujetos con remisión clínica según Mayo Adapted Score en la semana 52. Sub-estudio 3: Evaluación de la seguridad a largo plazo. |
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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. |
1. Proporción de sujetos con mejora endoscópica en la semana 52. 2. Proporción de sujetos que alcanzan remisión Clinica por full Mayo score en la semana 52. 3. Proporción de sujetos con remisión libre de esteroides en la semana 52. 4. Proporción de sujetos con remisión clínica substancial por Mayo Adapted score en la semana 52. 5. Proporción de sujetos que han discontinuado el uso de corticosteroides en la semana 52. 6. Proporción de sujetos con mejora sustancial endoscópica en la semana 52. 7. Proporción de sujetos con respuesta clínica por Adapted Mayo Score en la semana 52. 8. Proporción de sujetos con remisión endoscópica en la semana 52. 9. Proporción de sujetos con hospitalización hasta la semana 52. 10. Cambios en el cuestionario de síntomas de CU (UCSQ) desde la visita inicial, en la semana 52. 11. Proporción de sujetos con remisión histológica en la semana 52. 12. Proporción de sujetos con curación de la mucosa en la semana 52. 13. Cambios en el cuestionario de enfermedades del intestino (IBDQ) desde la visita inicial, en la semana 52. 14. Proporción de sujetos con cirugías relacionadas con la colitis ulcerosa hasta la semana 52. 15. Cambios desde la visita inicial en el Form-36, en la semana 52. 16. Cambios desde la visita inicial en FACIT-Fatigue, en la semana 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 | 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 | 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 | No |
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 |
Czech Republic |
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 |