Studies
| Study First Submitted Date | 2022-08-19 |
| Study First Posted Date | 2022-08-22 |
| Last Update Posted Date | 2023-08-01 |
| Start Month Year | October 24, 2023 |
| Primary Completion Month Year | July 18, 2027 |
| Verification Month Year | July 2023 |
| Verification Date | 2023-07-31 |
| Last Update Posted Date | 2023-08-01 |
Detailed Descriptions
| Sequence: | 20599309 |
| Description | Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study. |
Browse Interventions
| Sequence: | 95424746 | Sequence: | 95424747 | Sequence: | 95424748 | Sequence: | 95424749 | Sequence: | 95424750 | Sequence: | 95424751 | Sequence: | 95424752 | Sequence: | 95424753 | Sequence: | 95424754 | Sequence: | 95424755 | Sequence: | 95424756 |
| Mesh Term | Mirikizumab | Mesh Term | Anti-Inflammatory Agents, Non-Steroidal | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents | Mesh Term | Physiological Effects of Drugs | Mesh Term | Anti-Inflammatory Agents | Mesh Term | Antirheumatic Agents | Mesh Term | Anti-Ulcer Agents | Mesh Term | Gastrointestinal Agents |
| Downcase Mesh Term | mirikizumab | Downcase Mesh Term | anti-inflammatory agents, non-steroidal | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | anti-inflammatory agents | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | anti-ulcer agents | Downcase Mesh Term | gastrointestinal agents |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 51857746 |
| Name | Crohn's Disease |
| Downcase Name | crohn's disease |
Id Information
| Sequence: | 39907502 | Sequence: | 39907503 | Sequence: | 39907504 | Sequence: | 39907505 | Sequence: | 39907506 | Sequence: | 39907507 |
| Id Source | org_study_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id | Id Source | secondary_id |
| Id Value | 16632 | Id Value | I6T-MC-AMAY | Id Value | 2022-000811-29 | Id Value | MACARONI-23 | Id Value | PLATFORMPBCRD3001 | Id Value | I6T-MC-PIBD |
| Id Type | Other Identifier | Id Type | EudraCT Number | Id Type | Other Identifier | Id Type | Other Identifier | Id Type | Other Identifier | ||
| Id Type Description | Eli Lilly and Company | Id Type Description | Eli Lilly and Company | Id Type Description | Eli Lilly and Company | Id Type Description | Eli Lilly and Company | ||||
Design Groups
| Sequence: | 55285245 | Sequence: | 55285246 | Sequence: | 55285247 |
| Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
| Title | Mirikizumab Dose 1 | Title | Mirikizumab Dose 2 | Title | Mirikizumab Dose 3 |
| Description | Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (>) 40 kilograms (kg). | Description | Mirikizumab administered IV or SC in participants that weigh >20 kg to less than or equal to (≤) 40 kg. Dosing is based on assessments of the participant's weight and appropriate weight class. | Description | Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥)10 kg to less than or equal to ≤20 kg. Dosing is based on assessments of the participant's weight and appropriate weight class. |
Interventions
| Sequence: | 52177956 |
| Intervention Type | Drug |
| Name | Mirikizumab |
| Description | Administered IV or SC |
Keywords
| Sequence: | 79357942 |
| Name | Inflammatory Bowel Disease |
| Downcase Name | inflammatory bowel disease |
Design Outcomes
| Sequence: | 176361666 | Sequence: | 176361667 | Sequence: | 176361668 | Sequence: | 176361669 | Sequence: | 176361665 | Sequence: | 176361652 | Sequence: | 176361653 | Sequence: | 176361654 | Sequence: | 176361655 | Sequence: | 176361656 | Sequence: | 176361657 | Sequence: | 176361658 | Sequence: | 176361659 | Sequence: | 176361660 | Sequence: | 176361661 | Sequence: | 176361662 | Sequence: | 176361663 | Sequence: | 176361664 |
| Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Percentage of Participants Achieving Clinical Remission by PCDAI | Measure | Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and who did not have Crohn's disease (CD)-Related Surgery at Week 52 | Measure | Pharmacokinetics (PK): Clearance of Mirikizumab | Measure | Pharmacokinetics (PK): Volume of Distribution of Mirikizumab | Measure | Percentage of Participants Achieving Endoscopic Response | Measure | Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 | Measure | Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 | Measure | Percentage of Participants Achieving Clinical Response by PCDAI | Measure | Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI) | Measure | Percentage of Participants Achieving Clinical Remission by PCDAI | Measure | Percentage of Participants Achieving Clinical Remission by CDAI | Measure | Percentage of Participants Achieving Endoscopic Response by SES-CD | Measure | Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52 | Measure | Change from Baseline in C-reactive Protein (CRP) | Measure | Change from Baseline in CRP | Measure | Change from Baseline in Fecal calprotectin | Measure | Change from Baseline in Fecal calprotectin | Measure | Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52 |
| Time Frame | Week 52 | Time Frame | Baseline to Week 52 | Time Frame | Baseline through Week 52 | Time Frame | Baseline through Week 52 | Time Frame | Week 52 | Time Frame | Baseline to Week 52 | Time Frame | Baseline to Week 52 | Time Frame | Week 12 | Time Frame | Week 12 | Time Frame | Week 12 | Time Frame | Week 12 | Time Frame | Week 12 | Time Frame | Baseline to Week 52 | Time Frame | Baseline, Week 12 | Time Frame | Baseline, Week 52 | Time Frame | Baseline, Week 12 | Time Frame | Baseline, Week 52 | Time Frame | Baseline to Week 52 |
| Description | Clinical remission based on PCDAI | Description | Clinical response and clinical remission by PCDAI | Description | Endoscopic response by SES-CD | Description | Clinical response based on PCDAI, and endoscopic response based on SES-CD. | Description | Clinical response based on PCDAI, and clinical remission based on PCDAI. | Description | Clinical response based on PCDAI. | Description | Clinical response based on CDAI for participants ≥12 years of age | Description | Clinical remission based on PCDAI. | Description | Clinical remission based on CDAI for participants ≥12 years of age. | Description | Endoscopic response based on SES-CD. | Description | Clinical response by PCDAI, CDAI for participants ≥12 years of age |
Browse Conditions
| Sequence: | 192218500 | Sequence: | 192218501 | Sequence: | 192218502 | Sequence: | 192218503 | Sequence: | 192218504 | Sequence: | 192218505 |
| Mesh Term | Crohn Disease | Mesh Term | Inflammatory Bowel Diseases | Mesh Term | Gastroenteritis | Mesh Term | Gastrointestinal Diseases | Mesh Term | Digestive System Diseases | Mesh Term | Intestinal Diseases |
| Downcase Mesh Term | crohn disease | Downcase Mesh Term | inflammatory bowel diseases | Downcase Mesh Term | gastroenteritis | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | intestinal diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48029185 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Eli Lilly and Company |
Overall Officials
| Sequence: | 29102879 |
| Role | Study Director |
| Name | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST) |
| Affiliation | Eli Lilly and Company |
Central Contacts
| Sequence: | 11944353 |
| Contact Type | primary |
| Name | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
| Phone | 1-317-615-4559 |
| ClinicalTrials.gov@lilly.com | |
| Role | Contact |
Design Group Interventions
| Sequence: | 67773373 | Sequence: | 67773374 | Sequence: | 67773375 |
| Design Group Id | 55285245 | Design Group Id | 55285246 | Design Group Id | 55285247 |
| Intervention Id | 52177956 | Intervention Id | 52177956 | Intervention Id | 52177956 |
Eligibilities
| Sequence: | 30582141 |
| Gender | All |
| Minimum Age | 2 Years |
| Maximum Age | 17 Years |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. Participants must have moderately to severely active CD (as defined by a baseline PCDAI score >30). Participants must have endoscopy with evidence of active CD defined as as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study. Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor. Exclusion Criteria: Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery. Participants must not have an abscess. Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline. |
| Adult | False |
| Child | True |
| Older Adult | False |
Calculated Values
| Sequence: | 253856285 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 2 |
| Maximum Age Num | 17 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Secondary Outcomes To Measure | 16 |
Designs
| Sequence: | 30330306 |
| Allocation | Non-Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Intervention Other Names
| Sequence: | 26522826 |
| Intervention Id | 52177956 |
| Name | LY3074828 |
Links
| Sequence: | 4360933 |
| Url | https://trials.lilly.com/en-US/trial/356367 |
| Description | A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY) |
Responsible Parties
| Sequence: | 28709096 |
| Responsible Party Type | Sponsor |
Ipd Information Types
| Sequence: | 3316616 | Sequence: | 3316617 | Sequence: | 3316618 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Clinical Study Report (CSR) |