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 |
|
E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colitis 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 |
|
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 long-term efficacy of mirikizumab |
Evaluar la eficacia a largo plazo de mirikizumab |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the long-term effect of mirikizumab on health outcomes |
Evaluar la eficacia a largo plazo de mirikizumab desde el punto de vista de los resultados de salud |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients from the Phase 2 Study AMAC who in the opinion of the investigator, would derive benefit from treatment with mirikizumab 2. Patients from the Phase 3 Study AMBG who in the opinion of the investigator, would derive benefit from treatment with mirikizumab. 3. If female, must meet the contraception requirements. |
1. Pacientes procedentes del estudio de fase 2 AMAC, quienes, según el criterio del investigador, se beneficiarían del tratamiento con mirikizumab. 2. Pacientes procedentes del estudio de fase 3 AMBG, quienes, según el criterio del investigador, se beneficiarían del tratamiento con mirikizumab. 3. Las mujeres deben cumplir los requisitos relativos a las medidas anticonceptivas. |
|
E.4 | Principal exclusion criteria |
1. Would not, in the opinion of the investigator, derive clinical benefit from open-label treatment with mirikizumab. 2. Had a reported SAE in originator study or developed other condition prior to Week 0 visit that would disqualify them from treatment with mirikizumab according to originator study criteria. 3. Are diagnosed with any medical condition including developing malignancy or suspicion of active malignant disease during the originator study or prior to Week 0, which would have precluded enrollment in a prior mirikizumab study or would have required discontinuation. 4. Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study. |
1. Según el criterio del investigador, pacientes que no obtendrían beneficio clínico del tratamiento con mirikizumab sin enmascaramiento. 2. Pacientes que hayan notificado un AAG en el estudio anterior o presenten otra enfermedad antes de la visita de la semana 0 que haga que no cumplan los criterios para recibir tratamiento con mirikizumab de conformidad con los criterios del estudio previo. 3. Pacientes a los que se les hubiera diagnosticado cualquier enfermedad (entre otras, neoplasias malignas o sospecha de neoplasia maligna activa) durante el estudio anterior o antes de la semana 0, que impidiera su reclutamiento en un estudio anterior de mirikizumab o motivara la interrupción de su participación.
4. Participantes a los que se les haya diagnosticado una infección clínicamente importante, entre otras, hepatitis B, hepatitis C, VIH/sida y tuberculosis (TB) activa durante el estudio anterior. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of participants in clinical remission. Clinical remission is based on the modified Mayo Score (MMS). |
Porcentaje de participantes en remisión clínica, que se determina a partir de la puntuación modificada de Mayo (MMS). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Percentage of participants in endoscopic remission, based on the Mayo Endoscopic Score (ES). - Percentage of participants who are hospitalized due to UC over time. - Percentage of participants who undergo UC surgeries over time. - IBDQ scores over time |
- Porcentaje de participantes en remisión endoscópica de acuerdo con la puntuación endoscópica (PE) de Mayo. - Porcentaje de participantes a los que se les hospitalice por la CU a lo largo del tiempo. - Porcentaje de participantes a los que se les realice una intervención quirúrgica por la CU a lo largo del tiempo. - Puntuaciones del cuestionario IBDQ a lo largo del tiempo. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Weeks 52, 100 or 160 |
Semanas 52, 100 o 160 |
|
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 | Yes |
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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 214 |
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 |
Georgia |
Germany |
Hungary |
India |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Malaysia |
Mexico |
Moldova, Republic of |
Netherlands |
Poland |
Romania |
Russian Federation |
Saudi Arabia |
Serbia |
Slovakia |
Spain |
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
|
End of the study is the date of the last visit or last scheduled procedure for the last patient. |
El “final del estudio” es la fecha de la última visita o del último procedimiento programado para el último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 23 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
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 | 23 |