Ulcerative Colitis
Conditions
Brief summary
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).
Detailed description
Participants who complete the study will have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ).
Interventions
DRUGMirikizumab IV
Administered IV
DRUGMirikizumab SC
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Males or females weighing ≥10 kg and ≥2 and \<18 years old at the time of consent for screening. * Have moderate to severe UC. * Have failed corticosteroids, biologics, (for example, anti-tumor necrosis factor (TNF) antibodies or anti-integrin antibodies), immunomodulators (for example, azathioprine, thiopurines or methotrexate) or Janus Kinase (JAK)-Inhibitor treatment. * Have UC at least 3 months in duration before baseline, which includes endoscopic evidence of UC corroborated by a histopathology report.
Exclusion criteria
* Have Crohn's disease, Inflammatory Bowel Disease Unclassified, ulcerative proctitis or primary sclerosing cholangitis. * Have immune deficiency syndrome. * Previous bowel resection or intestinal surgery. * Evidence of toxic megacolon. * History or current evidence of cancer of the gastrointestinal tract.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants in MMS Clinical Remission | Week 12 | — |
| Percentage of Participants in MMS Clinical Response | Week 12 | — |
| Percentage of Participants with Endoscopic Remission | 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 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 | — |
| Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab | Baseline to Week 52 | PK: AUC of Mirikizumab |
| PK: Cmax of Mirikizumab | Baseline to Week 52 | — |
Countries
Belgium, Canada, France, Germany, Israel, Italy, Japan, Poland, South Korea, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 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
Outcome results
None listed