A Multicenter, Phase 3, Open-Label Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mirikizumab in Participants 2 Years to Less Than 18 Years of Age With Moderately to Severely Active Ulcerative Colitis
Overview
- Phase
- Phase 3
- Intervention
- Mirikizumab IV
- Conditions
- Ulcerative Colitis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 60
- Locations
- 93
- Primary Endpoint
- Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Intervention: Mirikizumab IV
Mirikizumab Weight-Based Group 1
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
Intervention: Mirikizumab SC
Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Intervention: Mirikizumab IV
Mirikizumab Weight-Based Group 2
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Intervention: Mirikizumab SC
Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Intervention: Mirikizumab IV
Mirikizumab Weight-Based Group 3
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Intervention: Mirikizumab SC
Outcomes
Primary Outcomes
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Time Frame: Baseline to Week 52
Secondary Outcomes
- Percentage of Participants Achieving MMS Clinical Response(Week 52)
- Percentage of Participants with Endoscopic Improvement(Week 12)
- 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 Achieving Pediatric Ulcerative Colitis Activity Index (PUCAI) Clinical Response(Week 12)
- Percentage of Participants Achieving PUCAI Clinical Remission(Week 52)
- Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement(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: Cmax of Mirikizumab(Baseline to Week 52)
- Percentage of Participants Achieving PUCAI Clinical Remission(Week 12)
- Percentage of Participants Achieving Histologic Endoscopic Mucosal Improvement(Week 12)