Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I6T-MC-AMBA | Other Identifier | Eli Lilly and Company | |
| 2022-502183-20-00 | Other Identifier | EU Trial Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirikizumab Weight-Based Group 1 | Experimental | Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC). |
|
| Mirikizumab Weight-Based Group 2 | Experimental | Experimental: Participants will receive mirikizumab weight-based dosing IV or SC. |
|
| Mirikizumab Weight-Based Group 3 | Experimental | Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirikizumab IV | Drug | Administered IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders | Baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in MMS Clinical Remission | Week 12 | |
| Percentage of Participants in MMS Clinical Response | Week 12 | |
| Percentage of Participants with Endoscopic Remission |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | United States | ||
| Children's Center for Digestive Health Care, LLC |
Not provided
| Label | URL |
|---|---|
| A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis (SHINE-2) | View source |
Not provided
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Mirikizumab SC | Drug | Administered SC |
|
|
| Week 12 |
| Percentage of Participants with Endoscopic Improvement | Week 12 |
| Percentage of Participants Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response | Week 12 |
| Percentage of Participants Achieving PUCAI Clinical Remission | Week 12 |
| Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement | Week 12 |
| Percentage of Participants Achieving MMS Clinical Response | Week 52 |
| Percentage of Participants Achieving MMS Clinical Remission | Week 52 |
| Percentage of Participants Achieving PUCAI Clinical Response | Week 52 |
| Percentage of Participants Achieving PUCAI Clinical Remission | Week 52 |
| Percentage of Participants Achieving Endoscopic Remission | Week 52 |
| Percentage of Participants Achieving Endoscopic Improvement | Week 52 |
| Percentage of Participants Achieving MMS Clinical Remission without Surgery at Week 52 among Clinical Responders at Week 12 and without the Use of Corticosteroids | Baseline to Week 52 |
| Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement | Week 52 |
| Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab | PK: AUC of Mirikizumab | Baseline to Week 52 |
| PK: Cmax of Mirikizumab | Baseline to Week 52 |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Riley Childrens Hospital | Indianapolis | Indiana | 46202 | United States |
| Washington University | St Louis | Missouri | 63110-1010 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| UZA | Edegem | 2650 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| The Hospital for Sick Children | Toronto | M5G 0A4 | Canada |
| Hôpital Necker - Enfants Malades | Paris | 75015 | France |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz | Mainz | 55131 | Germany |
| LMU-Campus Innenstadt | München | 80337 | Germany |
| Helios Klinikum Wuppertal | Wuppertal | 42283 | Germany |
| Shaare Zedek | Jerusalem | 9103102 | Israel |
| Hadassah University Hospital, Ein Kerem | Jerusalem | 911200 | Israel |
| Schneider Children's Medical Center | Petah Tikva | 4920235 | Israel |
| King Fahad Medical City | Rishon LeZiyyon | 70300 | Israel |
| Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer | Florence | 50139 | Italy |
| Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza | Roma | 00161 | Italy |
| Juntendo University Hospital | Bunkyō City | 113-8431 | Japan |
| Institute of Science Tokyo Hospital | Bunkyō City | 113-8519 | Japan |
| Kokikai Tsujinaka Hospital Kashiwanoha | Kashiwa-shi | 277-0871 | Japan |
| Saga University Hospital | Saga | 849-8501 | Japan |
| National Center for Child Health and Development | Setagaya-ku | 157-8535 | Japan |
| Yokohama City University Medical Center, Center of IBD | Yokohama | 232-0024 | Japan |
| Gabinet Lekarski Bartosz Korczowski | Rzeszów | 35-302 | Poland |
| Twoja Przychodnia-Szczecińskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| Medical Network Spółka z o. o., WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04-501 | Poland |
| Instytut 'Pomnik - Centrum Zdrowia Dziecka | Warsaw | 04-730 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 52-416 | Poland |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Sheffield Children's Hospital | Sheffield | S102TH | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708407 | mirikizumab |
Not provided
Not provided
Not provided