150 Participants Needed

Mirikizumab for Ulcerative Colitis

(SHINE-ON Trial)

Recruiting at 72 trial locations
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Overseen BySameer Lapsia
Age: < 65
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.12345

What 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.12345

How 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.14567

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.

Research Team

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility 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.
See 3 more

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

Treatment Details

Interventions

  • Mirikizumab
Trial Overview 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.
Participant Groups
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
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Approved in United States as Omvoh for:
  • Moderately to severely active ulcerative colitis
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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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Mirikizumab, an anti-IL-23p19 monoclonal antibody, was approved in March 2023 in Japan for treating moderate to severe ulcerative colitis, marking it as the first IL-23p19 inhibitor approved for this condition.
In the EU, mirikizumab received a positive opinion for adult patients with active ulcerative colitis who did not respond to conventional or biologic therapies, highlighting its potential as a new treatment option for difficult-to-treat cases.
Mirikizumab: First Approval.Keam, SJ.[2023]
Mirikizumab, an anti-interleukin-23 treatment, significantly improved histological and endoscopic outcomes in patients with moderately-to-severely active ulcerative colitis, showing better results compared to placebo in a study involving 1162 patients at Week 12 and 544 patients at Week 40.
Achieving early endoscopic and histological improvements with mirikizumab was linked to better long-term outcomes, including clinical remission and reduced symptoms, highlighting the importance of early intervention in managing ulcerative colitis.
Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes.Magro, F., Pai, RK., Kobayashi, T., et al.[2023]
In phase 3 studies (LUCENT-1 and LUCENT-2) involving 1162 patients with moderately-to-severely active ulcerative colitis, mirikizumab significantly improved quality of life outcomes, including scores on the Inflammatory Bowel Disease Questionnaire and the 36-Item Short Form Health Survey.
Mirikizumab-treated patients showed higher rates of achieving response and remission in quality of life measures compared to placebo, indicating its efficacy in enhancing overall well-being in patients with ulcerative colitis.
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.Sands, BE., Feagan, BG., Hunter Gibble, T., et al.[2023]

References

Mirikizumab: First Approval. [2023]
Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. [2023]
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 Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. [2023]
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]
Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. [2022]
Impact of Bowel Urgency on Quality of Life and Clinical Outcomes in Patients With Ulcerative Colitis. [2023]
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