Mirikizumab for Ulcerative Colitis
(SHINE-ON Trial)
Recruiting in Palo Alto (17 mi)
+64 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
Disqualifiers: Unstable illness, Adenomatous polyps, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing a medication called mirikizumab to see if it can help children with ulcerative colitis or Crohn's disease by reducing inflammation in their digestive tracts.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Mirikizumab for treating ulcerative colitis?
Mirikizumab has been shown to improve quality of life and reduce bowel urgency in patients with moderately to severely active ulcerative colitis, according to results from phase 3 clinical trials. It is also approved in Japan and received a positive opinion in the EU for patients who did not respond well to other treatments.
12345What safety data exists for Mirikizumab in humans?
Mirikizumab has been approved in Japan and received a positive opinion in the EU for treating ulcerative colitis, indicating it has undergone safety evaluations. However, the provided research articles focus on its effectiveness and quality of life improvements rather than specific safety data.
12345How is the drug Mirikizumab unique for treating ulcerative colitis?
Mirikizumab is unique because it is the first drug approved that specifically targets the IL-23p19 protein, which plays a role in inflammation, making it effective for patients who haven't responded well to other treatments. It has shown to significantly reduce bowel urgency, a common and distressing symptom of ulcerative colitis, improving patients' quality of life.
14567Eligibility Criteria
This trial is for pediatric patients who have ulcerative colitis or Crohn's disease and were part of previous mirikizumab studies. They should have completed the last study without serious side effects and could benefit from continued treatment. Girls must agree to use birth control, and participants can't join if they've had severe reactions before, stopped the drug due to risks, have unstable illnesses, untreated polyps, or are pregnant/breastfeeding.Inclusion Criteria
Participants from originating studies (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
I completed all required steps in a previous study and am still on the study medication.
I agree to follow the study's birth control requirements.
Exclusion Criteria
Participants must not be pregnant or breastfeeding.
I haven't had severe side effects from previous treatments that would make continuing treatment risky.
I have never stopped taking the study drug in a way that restarting it would be unsafe.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive various doses of Mirikizumab based on their condition and weight, with potential intravenous rescue dosing if response is lost
52 weeks
Up to 44 visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension
Long-term evaluation of the efficacy and safety of Mirikizumab in pediatric participants
116 weeks
Participant Groups
The trial tests the long-term effectiveness of a medication called mirikizumab in young patients with two types of inflammatory bowel diseases: ulcerative colitis and Crohn's disease. It spans roughly 172 weeks with up to 44 clinic visits to monitor how well the drug works over time.
7Treatment groups
Experimental Treatment
Group I: Mirikizumab Dose 7 for UC or CDExperimental Treatment1 Intervention
Intravenous (IV) rescue dosing, if response is lost.
Group II: Mirikizumab Dose 6 for CDExperimental Treatment1 Intervention
Dose 6 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group III: Mirikizumab Dose 5 for CDExperimental Treatment1 Intervention
Dose 5 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group IV: Mirikizumab Dose 4 for CDExperimental Treatment1 Intervention
Dose 4 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group V: Mirikizumab Dose 3 for UCExperimental Treatment1 Intervention
Dose 3 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group VI: Mirikizumab Dose 2 for UCExperimental Treatment1 Intervention
Dose 2 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group VII: Mirikizumab Dose 1 for UCExperimental Treatment1 Intervention
Dose 1 of Mirikizumab is administered subcutaneously (SC)
Dosing is based on the participant's weight.
Mirikizumab is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Omvoh for:
- Moderately to severely active ulcerative colitis
🇺🇸 Approved in United States as Omvoh for:
- Moderately to severely active ulcerative colitis
🇨🇦 Approved in Canada as Omvoh for:
- Moderately to severely active ulcerative colitis
🇯🇵 Approved in Japan as Omvoh for:
- Moderately to severely active ulcerative colitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Hospital for Sick ChildrenAtlanta, GA
UCSF Medical Center at Mission BaySan Francisco, CA
Children's Center for Digestive HealthcareAtlanta, GA
Children's Specialty Group, PPLCNorfolk, VA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Eli Lilly and CompanyLead Sponsor
References
Mirikizumab: First Approval. [2023]Mirikizumab (Omvoh®), a humanized IgG4 anti-human IL-23p19 monoclonal antibody, is being developed by Eli Lilly and Company Ltd for the treatment of ulcerative colitis and Crohn's disease. Mirikizumab was approved in March 2023 in Japan for use as induction and maintenance therapy in patients with moderate to severe ulcerative colitis who have an inadequate response to conventional therapy or therapies and is the first IL-23p19 inhibitor to be approved for this indication. Mirikizumab was granted a positive opinion in the EU in March 2023 for the treatment of adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. This article summarizes the milestones in the development of mirikizumab leading to this first approval for use in ulcerative colitis.
Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. [2023]To evaluate the effect of mirikizumab, a p19-targeted anti-interleukin-23, on histological and/or endoscopic outcomes in moderately-to-severely active ulcerative colitis [UC].
Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. [2023]Mirikizumab, an anti-IL-23p19 antibody, demonstrated efficacy in phase 3, randomized, double-blind, placebo-controlled LUCENT-1 (induction/NCT03518086) and LUCENT-2 (maintenance/NCT03524092) ulcerative colitis (UC) studies. We evaluated the effect of mirikizumab on quality-of-life (QoL) outcomes in these studies.
Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. [2023]Mirikizumab is a humanized anti-interleukin-23-p19 monoclonal antibody being developed for ulcerative colitis and Crohn's disease. This analysis characterized mirikizumab pharmacokinetics using phase II and III trial data from patients with moderately to severely active ulcerative colitis.
Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. [2023]Bowel urgency reduces ulcerative colitis patients' quality of life. Mirikizumab, a p19-directed anti-IL-23 antibody, demonstrates ulcerative colitis efficacy. Mirikizumab efficacy to reduce bowel urgency and bowel urgency association with other endpoints were analyzed in 2 Phase 3 trials.
Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. [2022]Mirikizumab is an antibody against the p19 subunit of interleukin 23 that has demonstrated clinical efficacy and was well tolerated following 12 weeks of induction treatment in a phase 2 trial of patients with moderate to severe ulcerative colitis. We present results of the open-label extended induction period in patients who did not initially respond to treatment with mirikizumab.
Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. [2023]Bowel urgency is commonly experienced by patients with ulcerative colitis (UC) and is associated with reduced health-related quality of life (QoL). Mirikizumab, a humanized monoclonal antibody directed against the p19 subunit of IL-23, significantly reduced bowel urgency in a double-blind, randomized, placebo-controlled Phase 2 clinical trial in patients with moderate-to-severe UC (NCT02589665).