Mirikizumab for Pediatric Ulcerative Colitis

(SHINE-2 Trial)

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Crohn's disease, Cancer, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since it mentions participants who have failed certain treatments, it's possible that some medication changes might be required. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the drug Mirikizumab for pediatric ulcerative colitis?

Mirikizumab has been shown to be effective in treating moderate to severe ulcerative colitis in adults, including those who did not respond to other treatments. It works by targeting a specific part of the immune system (IL-23) that is involved in inflammation, and it has been approved for use in several countries for this condition. ^{1 2 3 4 5}

Is Mirikizumab safe for humans?

Mirikizumab, also known as Omvoh, has been approved in Japan and received a positive opinion in the EU for treating ulcerative colitis, indicating it has been evaluated for safety in humans. While specific safety data is not detailed in the provided articles, its approval suggests that it has met safety standards for use in humans with ulcerative colitis. ^{1 2 3 6 7}

How is the drug Mirikizumab unique for treating pediatric 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 different from other treatments that may target different proteins or pathways. It is used for patients who do not respond well to conventional therapies, offering a new option for those with moderate to severe ulcerative colitis. ^{1 3 6 8 9}

Eligibility Criteria

This trial is for children and teens aged 2 to less than 18, weighing over 10 kg, with moderate to severe ulcerative colitis (UC) that's lasted at least 3 months. They should have tried other treatments like corticosteroids or biologics without success. It's not for those with Crohn's disease, certain other bowel conditions, a history of significant bowel surgery, toxic megacolon, or gastrointestinal cancer.

Inclusion Criteria

My ulcerative colitis is moderate to severe.

I have tried steroids, biologics, or other specific medications without success.

I have had ulcerative colitis for at least 3 months, confirmed by a colonoscopy and biopsy.

Exclusion Criteria

Evidence of toxic megacolon

Have immune deficiency syndrome

I have had surgery on my intestines before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC)

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension

Participants have the option to enter the long-term extension Study I6T-MC-AMAZ (AMAZ)

Treatment Details

Interventions

• Mirikizumab (Monoclonal Antibodies)

Trial Overview The study tests Mirikizumab given by IV (intravenous) or SC (subcutaneous injection) in young patients with UC. The goal is to see how well it works (efficacy), how the body processes it (pharmacokinetics), and its safety profile.

Participant Groups

Group I: Mirikizumab Weight-Based Group 3 Experimental Treatment 2 Interventions

Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.

Group II: Mirikizumab Weight-Based Group 2 Experimental Treatment 2 Interventions

Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.

Group III: Mirikizumab Weight-Based Group 1 Experimental Treatment 2 Interventions

Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).

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 Nearby Select from list below to view details:

St. Louis Children's Hospital Saint Louis, MO

Massachusetts General Hospital for Children Boston, MA

Children's Hospital Los Angeles Los Angeles, CA

IWK Health Centre Halifax, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Mirikizumab: First Approval. [2023] Mirikizumab (Omvoh&#174;), 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.

2. England pubmed.ncbi.nlm.nih.gov

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].

3. Switzerland pubmed.ncbi.nlm.nih.gov

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.

4. United States pubmed.ncbi.nlm.nih.gov

Mirikizumab Regulates Genes Involved in Ulcerative Colitis Disease Activity and Anti-TNF Resistance: Results From a Phase 2 Study. [2023] Mirikizumab, a monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, demonstrated efficacy and was well-tolerated in a phase 2 randomized clinical trial in patients with moderate-to-severe ulcerative colitis (UC) (NCT02589665). We explored gene expression changes in colonic tissue from study patients and their association with clinical outcomes.

5. England pubmed.ncbi.nlm.nih.gov

Mirikizumab for the treatment of moderate to severe ulcerative colitis. [2023] Despite a growing number of available therapeutic options for ulcerative colitis (UC), up to 50% of patients do not respond to initial treatment or lose response over time, highlighting the need for novel therapies. The IL-23 pathway has emerged as an important therapeutic target for UC. Mirikizumab is a humanized IgG4 monoclonal antibody against the p19 subunit of IL-23, dosed intravenously during induction and subcutaneously during maintenance. It is effective for the induction and maintenance of remission in moderately to severely active UC, including patients with prior failure of biological or tofacitinib therapy. Like other IL-23 antagonists, mirikizumab has a favorable safety profile. It is the first agent of its class to receive regulatory approval for moderately to severely active UC in Europe.

6. England pubmed.ncbi.nlm.nih.gov

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.

7. England pubmed.ncbi.nlm.nih.gov

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.

8. United States pubmed.ncbi.nlm.nih.gov

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.

9. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. [2022] Mirikizumab is a humanized monoclonal antibody targeting interleukin 23p19 with demonstrated efficacy in psoriasis and ulcerative colitis. We investigated the safety and efficacy of mirikizumab in patients with moderate-to-severe Crohn's disease (CD).