E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Ulcerative Colitis |
Colitis ulcerosa activa de moderada a grave. |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis Disease |
Colitis 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 |
To evaluate the efficacy of mirikizumab compared to placebo in percentage of participants in clinical remission at Week 40. |
Evaluar la eficacia de mirikizumab comparado con placebo en cuanto al logro de remisión clínica en la semana 40 entre los pacientes en que se indujo la respuesta clínica con mirikizumab |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of treatment with mirikizumab compared to placebo in percentage of participants in endoscopic remission at Week 40 - To evaluate the efficacy of treatment with mirikizumab compared to placebo in percentage of participants in corticosteroid-free remission without surgery at Week 40 |
- Evaluar la eficacia de mirikizumab comparado con placebo en cuanto a la remisión endoscópica en la semana 40 entre los pacientes en que se indujo la respuesta clínica con mirikizumab. -Evaluar la eficacia de mirikizumab comparado con placebo en cuanto al logro de remisión sin orticoesteroides y sin cirugía entre los pacientes en que se indujo la respuesta clínica con mirikizumab y que recibían corticoesteroides al inicio de la inducción. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have completed Study AMAN, with at least 1 study drug administration, without early termination of study drug, and underwent a Visit 5 (Week 12) endoscopy. 2. Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry. 3. If female, must meet the contraception requirements. |
1. Ha completado el estudio AMAN, con al menos 1 administración del fármaco del estudio, sin la finalización anticipada del fármaco del estudio, y se ha sometido a una endoscopia de la visita 5 (semana 12). 2. Está dispuesto y es capaz de completar las evaluaciones del estudio programadas, incluidas la endoscopia y las anotaciones diarias en el diario. 3. Si es mujer, debe cumplir los requisitos de métodos anticonceptivos. |
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E.4 | Principal exclusion criteria |
1. Participants diagnosed with Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN. 2. Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN, or are likely to require surgery for the treatment of UC during study AMBG. 3. Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN. 4. Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN. 5. Participants who initiate a new prohibited medication during the induction study AMAN. 6. Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug. |
1. Participantes con diagnóstico de enfermedad de Crohn o enfermedad inflamatoria intestinal no clasificada (colitis indeterminada) durante el estudio de inducción AMAN. 2. Participantes con una extirpación de intestino u otra cirugía para el tratamiento de la CU durante el estudio de inducción previo AMAN o que es probable que necesiten cirugía para el tratamiento de la CU durante el estudio AMBG. 3. Participantes con indicios de displasia colónica o a quienes se les haya diagnosticado cáncer del sistema gastrointestinal durante el estudio AMAN. 4. Participantes a quienes se les diagnosticó una infección importante, como hepatitis B, hepatitis C, VIH/SIDA y tuberculosis (TB) activa, entre otras, durante el estudio de inducción AMAN. 5. Participantes que iniciaron una nueva medicación prohibida durante el estudio de inducción AMAN. 6. Participantes con determinadas anomalías de laboratorio antes del inicio de AMBG que necesitarían la interrupción permanente del fármaco del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of participants in clinical remission at Week 40. Clinical remission is based on the Modified Mayo Score (MMS). |
Porcentaje de participantes en remisión clínica en la semana 40. La remisión clínica se basa en la puntuación Mayo modificada (modified Mayo score, MMS). |
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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) |
- Percentage of participants in endoscopic remission at Week 40. Endoscopic remission based on the Mayo endoscopic Score (ES) - Percentage of participants in corticosteroid-free remission without surgery at Week 40. Corticosteroid-free remission is based on the MMS. |
- Porcentaje de participantes en remisión endoscópica en la semana 40. La remisión endoscópica se basa en la puntuación Mayo endoscópica (Mayo endoscopic Score, ES). - Porcentaje de participantes en remisión sin corticoesteroides y sin cirugía en la semana 40. La remisión sin corticoesteroides se basa en la MMS. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | 4 |
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 | 16 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 179 |
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 |
Belgium |
Brazil |
Canada |
China |
Croatia |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
India |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
Poland |
Romania |
Russian Federation |
Saudi Arabia |
Serbia |
Slovakia |
Spain |
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
|
End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient |
El final del estudio es la fecha de la última visita o el último procedimiento programado que se muestra en el calendario de actividades para el último paciente |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 1 |