E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Ulcerative Colitis |
colite ulcerosa da moderatamente a gravemente attiva. |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis Disease |
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 evaluate the efficacy of mirikizumab compared to placebo in percentage of participants in clinical remission at Week 40. |
To evaluate the efficacy of mirikizumab compared to placebo in percentage of participants in clinical remission at Week 40. |
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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 |
- 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 |
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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.
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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.
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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.
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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.
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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). |
Percentage of participants in clinical remission at Week 40. Clinical remission is 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) |
- 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. |
- 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. |
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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 | 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 | 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 | 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, Republic of |
Malaysia |
Mexico |
Russian Federation |
Saudi Arabia |
Serbia |
Taiwan |
Turkey |
Ukraine |
United States |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |