Mirikizumab for Pediatric Crohn's Disease

(AMAY Trial)

Recruiting in Palo Alto (17 mi)

+128 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Symptomatic strictures, Stenosis, Short gut, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

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 participants must have a history of inadequate response or intolerance to certain medications, it's possible that some adjustments might be needed. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the drug Mirikizumab for treating Crohn's disease?

Mirikizumab has shown effectiveness in treating Crohn's disease and ulcerative colitis, which are both inflammatory bowel diseases. It works by targeting a specific protein involved in inflammation, and has been approved for use in ulcerative colitis in Japan and received positive opinions in the EU.

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Is Mirikizumab safe for humans?

Mirikizumab has been tested in people with conditions like ulcerative colitis and Crohn's disease, and it was generally well tolerated in these studies. It is a type of medicine called a monoclonal antibody, which targets specific proteins in the body to help reduce inflammation.

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How is the drug Mirikizumab different from other treatments for Crohn's disease?

Mirikizumab is unique because it targets interleukin 23p19, a specific part of the immune system involved in inflammation, and is the first drug of its kind approved for ulcerative colitis, which is similar to Crohn's disease. This makes it different from other treatments that may target different pathways or use different mechanisms to reduce inflammation.

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Eligibility Criteria

This trial is for pediatric patients with moderately to severely active Crohn's Disease, confirmed by specific medical criteria. They should have tried at least one treatment without success or could not tolerate it. Kids who've had recent bowel surgery or have complications like strictures that might need surgery can't join.

Inclusion Criteria

I have Crohn's disease and treatments I've tried haven't worked well for me.

My recent endoscopy shows active Crohn's disease.

I have been diagnosed with Crohn's disease or fistulizing Crohn's disease affecting my colon, ileum, or both.

Exclusion Criteria

I do not have severe Crohn's disease complications that might need surgery.

I do not have an abscess.

I haven't had bowel surgery in the last 6 months or any abdominal surgery in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive mirikizumab or another intervention to evaluate efficacy, safety, and tolerability

12 weeks

Up to 6 visits (in-person)

Maintenance

Participants continue treatment to assess long-term efficacy and safety

40 weeks

Up to 10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

3 visits (in-person)

Participant Groups

The study tests Mirikizumab's effectiveness and safety in children with Crohn's Disease over approximately 74 weeks, including a 12-week induction phase and up to Week 52 maintenance period, followed by a safety follow-up. Participants are randomly assigned to receive either Mirikizumab or another intervention.

Group I: Mirikizumab Dose 3 Experimental Treatment 1 Intervention

Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥) 9 kg to less than or equal to ≤20 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.

Group II: Mirikizumab Dose 2 Experimental Treatment 1 Intervention

Mirikizumab administered IV or SC in participants that weigh \>20 kg to less than or equal to (≤) 40 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.

Group III: Mirikizumab Dose 1 Experimental Treatment 1 Intervention

Mirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).

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:

Cedars Sinai Medical Center Los Angeles, CA

Atlantic Children's Health--Pediatric Gastroenterology Morristown, NJ

Texas Children's Hospital -Research Resource Office Houston, TX

Emory University Atlanta, GA

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company Lead Sponsor

References

1. 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).

2. 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.

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

Effects of Mirikizumab on Histologic Resolution of Crohn's Disease in a Randomized Controlled Phase 2 Trial. [2023] Histologic evaluation of mucosal healing in Crohn's disease (CD) is an evolving treatment target. We evaluated histologic outcomes for mirikizumab efficacy and associations with endoscopic and 1-year outcomes.

5. 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].

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

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. [2023] Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD.

7. 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.