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 M16-067 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. |
Estudio M16-067 comprende 2 sub-estudios: El objetivo del sub-estudio 1 es determinar la eficacia , seguridad y farmacocinética de risankizumab como tratamiento de inducción en pacientes con colitis ulcerosa(CU) de moderada a severa activa, e identificar la dosis de inducción apropiada de Risankizumab para una posterior evaluación en el sub-estudio 2. El objetivo en el sub-estudio 2 es evaluar la eficacia y seguridad de Risankizumab comparado con placebo en la inducción de remisión clínica en pacientes con colitis ulcerosa de moderada a severa activa. |
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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 |
- 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 - Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline. - Active UC. - Demonstrated intolerance or inadequate response to one or more biologic therapies. |
-Hombres o mujeres con edad >=18 a <= 80 años. Además, solo para el sub-estudio 2: donde sea localmente permitido, pacientes de 16 a < 18 años que cumplen con la definición del estadio 5 del desarrollo de Tanner en la visita basal. -Diagnóstico confirmado de colitis ulcerosa (CU) durante al menos 3 meses previos a la visita basal. - Colitis Ulcerosa activa. - Intolerancia demostrada o respuesta inadecuada a una o más terapias biológicas. |
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E.4 | Principal exclusion criteria |
- Subject with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation or ischemic colitis. - Subject receiving prohibited medications and treatment. - Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy. - Subject with currently known complications of UC. |
- Pacientes con un diagnostico actual de Enfermedad de Crohn (EC), Enfermedad del intestino inflamado no clasificado (IBD-U), antecedentes de radiación o colitis isquémica . - Sujetos pacientes que están recibiendo medicación prohibida y tratamiento. - Exentos de Enfermedad Inflamatoria limitada al recto y evaluado por una endoscopia de screening. -Sujetos con complicaciones actuales conocidas de colitis ulcerosa(CU). |
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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. |
-Proporción de sujetos con remisión clínica por Adapted Mayo Score en la semana 12. |
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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 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. Proporción de sujetos con mejoría endoscópica en la semana 12 2. Proporción de sujetos que alcanzan remisión clínica en la semana 12, en pacientes con Full Mayo Score de 6 a 12 en la visita basal. 3. Proporción de sujetos que alcanzan respuesta clínica en la semana 12. 4. Proporción de sujetos que alcanzan respuesta clínica en la semana 4. 5. Proporción de sujetos con remisión endoscópica en la semana 12. 6. Proporción de sujetos con hospitalizaciones hasta la semana 12. 7. Proporción de sujetos con curación de la mucosa en la semana 12. 8. Cambios ,desde la visita de base, en el cuestionario de síntomas de colitis ulcerosa(UC-SQ) en la semana 12. 9. Cambios, desde la visita de base, en el cuestionario de enfermedades inflamatorias del intestino (IBDQ) en la semana 12. 10. Cambios desde la visita de base en el form-36, en la semana 12. 11. Cambios, desde la visita de base, en la evaluación funcional de la terapia-fatiga de la enfermedad de Crohn (FACITFatigue) en la semana 12. 12. Proporción de sujetos con cirugías relacionadas con la colitis ulcerosa hasta la semana 12. |
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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. Semana 12 2. Basal, Semana 12 3. Semana 12 4. Semana 4 5. Semana 12 6. Semana 12 7. Semana 12 8. Basal, Semana 12 9. Basal, Semana 12 10. Basal, Semana 12 11. Basal, Semana 12 12. 12 Semanas |
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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 | 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 |
Slovenia |
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 | 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 |