Mirikizumab for Pediatric Crohn's Disease (AMAY Trial)
Palo Alto (17 mi)Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
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.
Is the drug Mirikizumab a promising treatment for Pediatric Crohn's Disease?Yes, Mirikizumab is a promising drug for treating Crohn's Disease. It has shown effectiveness in treating similar conditions like ulcerative colitis and has been approved for use in some countries. This suggests it could be beneficial for Crohn's Disease as well.12567
What safety data is available for Mirikizumab in treating Crohn's Disease?Mirikizumab has been evaluated for safety in a Phase 2 study for patients with moderate-to-severe Crohn's Disease, as well as in trials for ulcerative colitis. It has demonstrated clinical efficacy and was well tolerated in a Phase 2 trial for ulcerative colitis. Additionally, it has been approved in Japan and received a positive opinion in the EU for ulcerative colitis, indicating a favorable safety profile in these contexts.12356
What data supports the idea that Mirikizumab for Pediatric Crohn's Disease is an effective treatment?The available research shows that Mirikizumab has been effective in treating conditions similar to Crohn's Disease, like ulcerative colitis. It has been approved in Japan and received positive opinions in the EU for treating ulcerative colitis, which suggests its potential effectiveness for Crohn's Disease as well. In studies, Mirikizumab has shown positive results in healing the gut lining in Crohn's Disease, which is a key goal in treatment. While specific data for pediatric Crohn's Disease isn't detailed, its success in related conditions supports its potential effectiveness.24567
Do I have to stop taking my current medications for the trial?The trial protocol 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 at least one medication for Crohn's disease, it's possible that some medications may need to be adjusted. Please consult with the trial coordinators for specific guidance.
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.Treatment Details
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.
3Treatment groups
Experimental Treatment
Group I: Mirikizumab Dose 3Experimental Treatment1 Intervention
Mirikizumab administered IV or SC in participants that weigh greater than or equal to (≥)10 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 2Experimental Treatment1 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 1Experimental Treatment1 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 nearbySelect from list below to view details:
Cedars Sinai Medical CenterLos Angeles, CA
Atlantic Children's Health--Pediatric GastroenterologyMorristown, NJ
Texas Children's Hospital -Research Resource OfficeHouston, TX
Emory UniversityAtlanta, GA
More Trial Locations
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
References
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.
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).
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.
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: 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.
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.
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.