A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

Study of Mirikizumab for Pediatric Crohn's Disease

NCT: NCT05509777 · Status: RECRUITING · Phase: Phase 3 · Sponsor: Eli Lilly and Company · Started: 2024-03-13 · Est. Completion: 2028-04

Plain English Summary

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease is a Phase 3 clinical trial sponsored by Eli Lilly and Company studying Crohn's Disease. Tests the effectiveness and safety of Mirikizumab in children with Crohn's disease. For children aged 6 to 17 with active Crohn's disease who haven't responded well to other treatments. Participation involves up to 19 visits over 74 weeks, including an induction period and maintenance phase. Alternatives include other medications or biologics, but this study focuses on a new treatment option. The trial aims to enroll 90 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Must be between 6 and 17 years old. Must have active Crohn's disease confirmed by clinical, endoscopic, and histologic criteria. Must have had an inadequate response to at least one previous treatment. Cannot have complications like strictures, stenosis, or abscesses. This trial is studying Crohn's Disease, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures show how well the treatment works in reducing symptoms and improving quality of life for children with Crohn's disease. The specific primary outcome measures are: Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 (Baseline to Week 52); Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 (Baseline to Week 52). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial is crucial as it aims to fill a treatment gap for pediatric Crohn's disease patients who haven't responded to other therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Crohn's Disease, where improved treatment options are needed.

Investor Insight

The market for pediatric Crohn's disease treatments is growing, with this study potentially leading to new approval opportunities. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if you or your child qualifies for the study. Participation involves regular visits and monitoring of symptoms and side effects. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

  • Study Type: INTERVENTIONAL
  • Allocation: NON_RANDOMIZED
  • Model: PARALLEL
  • Masking: NONE
  • Enrollment: 90 participants

Interventions

  • DRUG: Mirikizumab — Administered IV or SC

Primary Outcomes

  • Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 (Baseline to Week 52)
  • Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 (Baseline to Week 52)

Secondary Outcomes

  • Percentage of Participants Achieving Clinical Response by PCDAI (Week 12)
  • Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI) (Week 12)
  • Percentage of Participants Achieving Clinical Remission by PCDAI (Week 12)
  • Percentage of Participants Achieving Clinical Remission by CDAI (Week 12)
  • Percentage of Participants Who Achieve PCDAI Clinical Response at Week 12 and PCDAI Clinical Remission and Endoscopic Remission at Week 52 (Baseline to Week 52)

Full Eligibility Criteria

Inclusion Criteria:

* Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
* Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).
* Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.
* Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.

Exclusion Criteria:

* Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.
* Participants must not have an abscess.
* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Trial Locations

  • Cedars Sinai Medical Center, Los Angeles, California, United States
  • Connecticut Children's Medical Center, Hartford, Connecticut, United States
  • Emory University, Atlanta, Georgia, United States
  • Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States
  • Riley Childrens Hospital, Indianapolis, Indiana, United States
  • Boston Children's Hospital, Boston, Massachusetts, United States
  • Atlantic Children's Health--Pediatric Gastroenterology, Morristown, New Jersey, United States
  • Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC), New York, New York, United States
  • Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Columbia University Medical Center/New York Presbyterian, New York, New York, United States
  • ...and 10 more locations

Frequently Asked Questions

What is clinical trial NCT05509777?

NCT05509777 is a Phase 3 INTERVENTIONAL study titled "A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease." It is currently recruiting and is sponsored by Eli Lilly and Company. The trial targets enrollment of 90 participants.

What conditions does NCT05509777 study?

This trial investigates treatments for Crohn's Disease. The primary condition under study is Crohn's Disease.

What treatments are being tested in NCT05509777?

The interventions being studied include: Mirikizumab (DRUG). Administered IV or SC

What does Phase 3 mean for NCT05509777?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT05509777?

This trial is currently "Recruiting." It started on 2024-03-13. The estimated completion date is 2028-04.

Who is sponsoring NCT05509777?

NCT05509777 is sponsored by Eli Lilly and Company. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05509777?

The trial aims to enroll 90 participants. The trial is currently recruiting and accepting new participants.

How is NCT05509777 designed?

This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT05509777?

The primary outcome measures are: Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 (Baseline to Week 52); Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 (Baseline to Week 52). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05509777 being conducted?

This trial is being conducted at 20 sites, including Los Angeles, California; Hartford, Connecticut; Atlanta, Georgia; Indianapolis, Indiana and 16 more sites (United States, Austria, Belgium).

Where can I find official information about NCT05509777?

The official record for NCT05509777 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05509777. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05509777 testing in simple terms?

Tests the effectiveness and safety of Mirikizumab in children with Crohn's disease. For children aged 6 to 17 with active Crohn's disease who haven't responded well to other treatments.

Why is this trial significant?

This trial is crucial as it aims to fill a treatment gap for pediatric Crohn's disease patients who haven't responded to other therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT05509777?

Potential side effects include injection site reactions and infections. Monitor for any unusual symptoms and report them to your healthcare provider. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05509777?

Ask your doctor if you or your child qualifies for the study. Participation involves regular visits and monitoring of symptoms and side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05509777 signal from an investment perspective?

The market for pediatric Crohn's disease treatments is growing, with this study potentially leading to new approval opportunities. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participation involves up to 19 visits over 74 weeks, including an induction period and maintenance phase. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Crohn's Disease Trials

View all Crohn's Disease clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.