E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to severely active Ulcerative Colitis |
Colite Ulcerosa attiva da moderata a grave |
|
E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colite 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 |
Valutare l'efficacia a lungo termine di Mirikizumab |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the long-term effect of mirikizumab on health outcomes |
Valutare l'effetto a lungo termine di mirikizumab sugli esiti sanitari |
|
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. Pazienti provenienti dallo studio AMAC di Fase 2 che secondo il giudizio dello sperimentatore, trarrebbero beneficio dal trattamento con mirikizumab 2. Pazienti provenienti dallo studio AMBG di Fase 3 che secondo il giudizio dello sperimentatore, trarrebbero beneficio dal trattamento con mirikizumab 3. Le pazienti di sesso femminile devono soddisfare i requisiti di contraccezione. |
|
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. Secondo il giudizio dello sperimentatore, il paziente potrebbe non derivare alcun beneficio clinico dal from open-label treatment with mirikizumab. 2. Pazienti che hanno riportato un SAE nello studio di origine o hanno sviluppato altre condizioni prima della visita della Settimana 0 che potrebbero squalificarli dal trattamento con mirikizumab secondo i criteri dello studio di origine. 3. Pazienti che abbiano una diagnosi di qualsiasi condizione medica compreso lo sviluppo di tumori maligni o il sospetto di patologia maligna attiva durante lo studio di origine o prima della Settimana 0, che potrebbe precluderli dall’arruolamento in un precedente studio con mirikizumab o che richiederebbe l’interruzione 4. Partecipanti ai quali è stata diagnosticata un’infezione clinicamente importante, ma non limitatamente a, epatite B, epatite C, HIV/AIDS, e tubercolosi (TBC) attiva durante uno studio di origine. |
|
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). |
Percentuale di partecipanti in remissione clinica. La remissione clinica è basata sul punteggio Mayo modificato |
|
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. - Percentage of participants who undergo UC surgeries over time. - IBDQ scores over time |
- Percentuale di partecipanti in remissione endoscopica, sulla base del punteggio endoscopico Mayo (ES). - Percentuale di partecipanti che sono ricoverati in ospedale a causa di CU nel tempo . - Percentuale di partecipanti che si sottopongono a interventi chirurgici della CU nel tempo. - Punteggi IBDQ nel tempo |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Weeks 52, 100 or 160 |
Settimane 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 | Yes |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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 | 9 |
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 | 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 |
Australia |
Brazil |
Canada |
China |
Georgia |
India |
Israel |
Japan |
Korea, Republic of |
Malaysia |
Mexico |
Moldova, Republic of |
Russian Federation |
Saudi Arabia |
Serbia |
Taiwan |
Turkey |
Ukraine |
United States |
Austria |
Belgium |
Croatia |
Denmark |
France |
Germany |
Hungary |
Ireland |
Italy |
Latvia |
Lithuania |
Netherlands |
Poland |
Romania |
Slovakia |
Spain |
Switzerland |
United Kingdom |
Czechia |
Argentina |
|
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. |
La fine dello studio coincide con la data dell'ultima visita o l'ultima attività schedulata per l'ultimo paziente |
|
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 |