E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
- Crohn´s Disease. - Moderately to severely active Ulcerative Colitis. |
- Malattia di Chron - Colite Ulcerosa da moderata a severa |
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E.1.1.1 | Medical condition in easily understood language |
- Crohn´s Disease; - Ulcerative Colitis. |
- Malattia di Chron - Colite Ulcerosa |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 |
For CD ISA: - To evaluate the efficacy of mirikizumab in pediatric participants with Crohn’s disease. For UC ISA: - To evaluate the efficacy of mirikizumab in pediatric participants with UC.
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For CD ISA: - To evaluate the efficacy of mirikizumab in pediatric participants with Crohn’s disease. For UC ISA: - To evaluate the efficacy of mirikizumab in pediatric participants with UC. |
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E.2.2 | Secondary objectives of the trial |
For CD ISA: 1. To evaluate the long-term efficacy of mirikizumab treatment in pediatric participants with Crohn’s disease; 2. To evaluate the long-term effect of mirikizumab treatment on growth in pediatric participants with Crohn’s disease. For UC ISA: 1. To evaluate the long-term efficacy of mirikizumab treatment in pediatric participants with UC; 2. To evaluate the long-term effect of mirikizumab treatment on growth in pediatric participants with UC.
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For CD ISA: 1. To evaluate the long-term efficacy of mirikizumab treatment in pediatric participants with Crohn’s disease; 2. To evaluate the long-term effect of mirikizumab treatment on growth in pediatric participants with Crohn’s disease. For UC ISA: 1. To evaluate the long-term efficacy of mirikizumab treatment in pediatric participants with UC; 2. To evaluate the long-term effect of mirikizumab treatment on growth in pediatric participants with UC. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants from originating studies who should, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab; - Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug; - Female participants must agree to contraception requirements.
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- Participants from originating studies who should, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab; - Participants from prior studies who have had at least one study drug administration and have not had early termination of study drug; - Female participants must agree to contraception requirements. |
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E.4 | Principal exclusion criteria |
- Participants must not have developed a new condition, including cancer in the originator study; - Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during any originator study; - Participants must not have received surgery for UC or CD (as applicable) in the originator study or are likely to require surgery for treatment of UC or CD during the study; - Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access.
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- Participants must not have developed a new condition, including cancer in the originator study; - Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during any originator study; - Participants must not have received surgery for UC or CD (as applicable) in the originator study or are likely to require surgery for treatment of UC or CD during the study; - Participants must not require parenteral nutrition delivered by central vein and/or central venous catheter for venous access. |
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E.5 End points |
E.5.1 | Primary end point(s) |
For CD ISA: - Proportion of participants in clinical remission by PCDAI at Week 52 (total mirikizumab treatment of 2 years). For UC ISA: - Proportion of participants in MMS clinical remission at Week 52 (total mirikizumab treatment of 2 years).
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For CD ISA: - Proportion of participants in clinical remission by PCDAI at Week 52 (total mirikizumab treatment of 2 years). For UC ISA: - Proportion of participants in MMS clinical remission at Week 52 (total mirikizumab treatment of 2 years). |
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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) |
For CD ISA: 1. Proportion of participants with endoscopic remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 2. Proportion of participants achieving endoscopic response at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 3. Proportion of participants achieving histologic remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 4. Proportion of participants achieving clinical remission by PRO at: - Week 52 (total mirikizumab treatment of 2 years); - Week 104 (total mirikizumab treatment of 3 years); - Week 156 (total mirikizumab treatment of 4 years); 5. Proportion of participants who achieve both clinical remission by PCDAI and endoscopic response at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 6. Observed height velocity; 7. Change from baseline in weight (kg); 8. Change from baseline in height; For UC ISA: 1. Proportion of participants in MMS clinical remission at Week 156 (total mirikizumab treatment of 4 years). 2. Proportion of participants in PUCAI clinical remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 104 (total mirikizumab treatment of 3 years); - Week 156 (total mirikizumab treatment of 4 years); 3. Proportion of participants in endoscopic remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 4. Proportion of participants in histologic remission (as defined in the SAP) at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 5. Observed height velocity by sex and age at approximately 6-month intervals throughout the trial; 6. Change from baseline in weight (kg) at study visits by sex and age group; 7. Change from baseline in height at study visits by sex and age group. |
For CD ISA: 1. Proportion of participants with endoscopic remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 2. Proportion of participants achieving endoscopic response at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 3. Proportion of participants achieving histologic remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 4. Proportion of participants achieving clinical remission by PRO at: - Week 52 (total mirikizumab treatment of 2 years); - Week 104 (total mirikizumab treatment of 3 years); - Week 156 (total mirikizumab treatment of 4 years); 5. Proportion of participants who achieve both clinical remission by PCDAI and endoscopic response at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 6. Observed height velocity; 7. Change from baseline in weight (kg); 8. Change from baseline in height; For UC ISA: 1. Proportion of participants in MMS clinical remission at Week 156 (total mirikizumab treatment of 4 years). 2. Proportion of participants in PUCAI clinical remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 104 (total mirikizumab treatment of 3 years); - Week 156 (total mirikizumab treatment of 4 years); 3. Proportion of participants in endoscopic remission at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 4. Proportion of participants in histologic remission (as defined in the SAP) at: - Week 52 (total mirikizumab treatment of 2 years); - Week 156 (total mirikizumab treatment of 4 years); 5. Observed height velocity by sex and age at approximately 6-month intervals throughout the trial; 6. Change from baseline in weight (kg) at study visits by sex and age group; 7. Change from baseline in height at study visits by sex and age group. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Week 52; - Week 104; - Week 156; |
- Week 52; - Week 104; - Week 156; |
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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 | No |
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 | 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 | 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
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 |
Argentina |
Australia |
Canada |
Israel |
Japan |
Korea, Republic of |
United States |
Austria |
France |
Latvia |
Lithuania |
Poland |
Netherlands |
Spain |
Czechia |
Germany |
Italy |
Belgium |
Denmark |
Hungary |
Norway |
Portugal |
Slovakia |
United Kingdom |
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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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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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |