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Monoclonal Antibodies
Mirikizumab for Pediatric Ulcerative Colitis (SHINE-2 Trial)
Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
SHINE-2 Trial Summary
This trial studies if a drug is safe & effective in treating UC in children.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of Mirikizumab may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, abdominal pain and potential allergic reactions.
SHINE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with modified Mayo score (MMS) Clinical Remission at Week 52 among the Week 12 Clinical Responders
Secondary outcome measures
PK: Cmax of Mirikizumab
Percentage of Participants Achieving Endoscopic Improvement
Percentage of Participants Achieving Endoscopic Remission
+12 moreSHINE-2 Trial Design
3Treatment groups
Experimental Treatment
Group I: Mirikizumab Weight-Based Group 3Experimental Treatment2 Interventions
Experimental: Mirikizumab Participants will receive mirikizumab weight-based dosing IV or SC.
Group II: Mirikizumab Weight-Based Group 2Experimental Treatment2 Interventions
Experimental: Participants will receive mirikizumab weight-based dosing IV or SC.
Group III: Mirikizumab Weight-Based Group 1Experimental Treatment2 Interventions
Experimental: Participants will receive mirikizumab weight-based dosing intravenously (IV) or subcutaneously (SC).
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Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,539 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
4,106 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,685 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
3,956 Patients Enrolled for Ulcerative Colitis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My ulcerative colitis is moderate to severe.I have had surgery on my intestines before.I have or had cancer in my digestive system.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.I have Crohn's disease, ulcerative proctitis, or primary sclerosing cholangitis.I am between 2 and 18 years old and weigh more than 10 kg.
Research Study Groups:
This trial has the following groups:- Group 1: Mirikizumab Weight-Based Group 1
- Group 2: Mirikizumab Weight-Based Group 2
- Group 3: Mirikizumab Weight-Based Group 3
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What criteria must be met to fulfill participation in this clinical trial?
"To partake in this investigation, pediatric patients between the ages of 2 and 17 with a diagnosis of ulcerative colitis are welcome to apply. 60 applicants will be admitted in total."
Answered by AI
Does this research embrace participants who are of legal age?
"This medical experiment seeks to enroll participants aged between 2 and 17 years old."
Answered by AI
What potential risks accompany the use of Mirikizumab Weight-Based Group 2 medication?
"Mirikizumab Weight-Based Group 2 has been allocated a safety rating of 3, as there is existing clinical evidence supporting its efficacy and data that demonstrate its security."
Answered by AI
Are new participants currently being welcomed into this research?
"As confirmed on clinicaltrials.gov, the trial is not presently recruiting any participants - a status which was last updated on August 8th 2023. Despite this particular study no longer being open for enrollment, there are still 409 other trials actively seeking candidates."
Answered by AI
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