Crohn's Disease, Inflammatory Bowel Diseases, Ulcerative Colitis, Ulcerative Colitis Chronic
Conditions
Keywords
Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Pediatric UC, Pediatric CD
Brief summary
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
Interventions
DRUGMirikizumab
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 19 Years
Healthy volunteers
No
Inclusion criteria
* Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab * Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. * Female participants must agree to contraception requirements.
Exclusion criteria
* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant. * Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ. * Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. * Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. * Participants must not have adenomatous polyps that have not been removed. * Participants must not be pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission | Week 52 | Clinical Remission based on the MMS |
| Percentage of Participants with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission | Week 52 | Clinical Remission based on the PCDAI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with UC in Corticosteroid-free Remission Without Surgery | Week 52 | Corticosteroid-free Remission based on MMS in participants who did not have an ulcerative colitis (UC)-related surgery |
| Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery | Week 52 | Corticosteroid-free Remission based on PCDAI in participants who did not have Crohn's disease (CD-related surgery) |
| Time to First Dose of Corticosteroid Among Participants with UC Entering Study AMAZ Not on Corticosteroids | Week 0 to Week 52 | — |
| Percentage of Participants Who Achieve both Clinical Remission by PCDAI and Endoscopic Response | Week 52 | — |
| Change from Baseline Over Time in C-reactive Protein, High Sensitivity (hsCRP) | Baseline, Week 0 to Week 52 | — |
| Percentage of Participants with UC in Endoscopic Response | Week 52 | Endoscopic Response in Participants based on the ES |
| Percentage of Participants with CD in Endoscopic Response | Week 52 | Endoscopic Response based on the SES-CD |
| Percentage of Participants with UC in having Endoscopic Subscore = 0 | Week 52 | Endoscopic Remission when ES = 0 |
| Percentage of Participants with UC in MMS Clinical Response | Week 52 | Clinical Response based on the MMS |
| Percentage of Participants with CD in PCDAI Clinical Response | Week 52 | Clinical Response based on the PCDAI |
| Percentage of Participants with UC in Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response | Week 52 | Clinical Response based on the PUCAI |
| Percentage of Participants with UC in PUCAI Clinical Remission | Week 52 | Clinical Response based on the PUCAI |
| Percentage of Participants with UC in Endoscopic Remission | Week 52 | Endoscopic Remission based on the Endoscopic Subscore (ES) |
| Percentage of Participants with UC Histologic-Endoscopic Mucosal Remission | Week 52 | Histologic remission based on histology scoring and endoscopic remission based on endoscopy score |
| Percentage of Participants with CD in Endoscopic Remission | Week 52 | Endoscopic Remission in Participants based on the Simple Endoscopic Score for Crohn's Disease (SES-CD) |
| Percentage of Participants with CD Achieving Histologic Remission | Week 52 | Histologic remission based on histology scoring |
Countries
Austria, Belgium, Brazil, Canada, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Portugal, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
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