E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colite ulcerosa |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colite 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 test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission at Week 12 in patients with moderately to severely active ulcerative colitis.
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To test the hypothesis that mirikizumab is superior to placebo in inducing clinical remission at Week 12 in patients with moderately to severely active ulcerative colitis.
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving clinical response at Week 12. 2. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving endoscopic remission at Week 12. 3. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving symptomatic remission at Week 12.
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1. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving clinical response at Week 12. 2. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving endoscopic remission at Week 12. 3. To evaluate the efficacy of treatment with mirikizumab compared to placebo in achieving symptomatic remission at Week 12. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Principal Inclusion Criteria are as follows: 1. Male or female patients >=18 and <=80 years of age at the time of initial screening 2. Diagnosis of UC for at least 3 months prior to baseline. 3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). 4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC. 5. If female, must meet the contraception requirements. |
Principal Inclusion Criteria are as follows: 1. Male or female patients =>18 and <=80 years of age at the time of initial screening 2. Diagnosis of UC for at least 3 months prior to baseline. 3. Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS). 4. Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC. 5. If female, must meet the contraception requirements. |
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E.4 | Principal exclusion criteria |
Principal Exclusion Criteria are as follows: 1. Patients with a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis). 2. Patients with a previous colectomy. 3. Patients with current evidence of toxic megacolon. 4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab). |
Principal Exclusion Criteria are as follows: 1. Patients with a current diagnosis of Crohn’s disease or inflammatory bowel disease-unclassified (indeterminate colitis). 2. Patients with a previous colectomy. 3. Patients with current evidence of toxic megacolon. 4. Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of participants in clinical remission at Week 12, based on the Modified Mayo Score (MMS) |
Percentage of participants in clinical remission at Week 12, based on the 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) |
1. Percentage of participants achieving clinical response at Week 12 based on the MMS. 2. Percentage of participants achieving endoscopic remission at Week 12 based on the MMS . 3. Percentage of participants achieving symptomatic remission at Week 12 based on the MMS . |
1. Percentage of participants achieving clinical response at Week 12 based on the MMS. 2. Percentage of participants achieving endoscopic remission at Week 12 based on the MMS . 3. Percentage of participants achieving symptomatic remission at Week 12 based on the 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 | 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 | 2 |
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 | 18 |
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 | 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 |
India |
Israel |
Japan |
Korea, Democratic People's Republic of |
Korea, Republic of |
Malaysia |
Mexico |
Russian Federation |
Saudi Arabia |
Serbia |
Taiwan |
Turkey |
Ukraine |
Austria |
Belgium |
Croatia |
Denmark |
France |
Germany |
Ireland |
Italy |
Latvia |
Lithuania |
Netherlands |
Poland |
Romania |
Slovakia |
Spain |
Switzerland |
United Kingdom |
Czechia |
Argentina |
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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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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 |
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 |
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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 | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |