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Monoclonal Antibodies
Mirikizumab for Ulcerative Colitis (SHINE-ON 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 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
SHINE-ON Trial Summary
This trial will last 172 weeks and follow children with UC or Crohn's to evaluate the long-term efficacy of mirikizumab.
Who is the study for?
This trial is for pediatric patients who have ulcerative colitis or Crohn's disease and were part of previous mirikizumab studies. They should have completed the last study without serious side effects and could benefit from continued treatment. Girls must agree to use birth control, and participants can't join if they've had severe reactions before, stopped the drug due to risks, have unstable illnesses, untreated polyps, or are pregnant/breastfeeding.Check my eligibility
What is being tested?
The trial tests the long-term effectiveness of a medication called mirikizumab in young patients with two types of inflammatory bowel diseases: ulcerative colitis and Crohn's disease. It spans roughly 172 weeks with up to 44 clinic visits to monitor how well the drug works over time.See study design
What are the potential side effects?
While not explicitly listed here, common side effects for drugs like mirikizumab may include injection site reactions, increased risk of infection, headaches, fatigue, abdominal pain, and potential allergic responses.
SHINE-ON 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 CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission
Secondary outcome measures
Percentage of Participants with CD Achieving Histologic Response
Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery
Percentage of Participants with CD in Endoscopic Remission
+10 moreSHINE-ON Trial Design
7Treatment groups
Experimental Treatment
Group I: Mirikizumab Dose 7 for UC or CDExperimental Treatment1 Intervention
Intravenous (IV) rescue dosing, if response is lost.
Group II: Mirikizumab Dose 6 for CDExperimental Treatment1 Intervention
Dose 6 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group III: Mirikizumab Dose 5 for CDExperimental Treatment1 Intervention
Dose 5 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group IV: Mirikizumab Dose 4 for CDExperimental Treatment1 Intervention
Dose 4 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group V: Mirikizumab Dose 3 for UCExperimental Treatment1 Intervention
Dose 3 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group VI: Mirikizumab Dose 2 for UCExperimental Treatment1 Intervention
Dose 2 of Mirikizumab is administered SC
Dosing is based on the participant's weight.
Group VII: Mirikizumab Dose 1 for UCExperimental Treatment1 Intervention
Dose 1 of Mirikizumab is administered subcutaneously (SC)
Dosing is based on the participant's weight.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
2020
Completed Phase 3
~4790
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,619 Previous Clinical Trials
3,206,449 Total Patients Enrolled
Study DirectorEli Lilly and Company
1 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had severe side effects from previous treatments that would make continuing treatment risky.I have never stopped taking the study drug in a way that restarting it would be unsafe.I completed all required steps in a previous study and am still on the study medication.I agree to follow the study's birth control requirements.I do not have any uncontrolled illnesses that could make participating unsafe for me.I do not have any unremoved adenomatous polyps.
Research Study Groups:
This trial has the following groups:- Group 1: Mirikizumab Dose 5 for CD
- Group 2: Mirikizumab Dose 4 for CD
- Group 3: Mirikizumab Dose 6 for CD
- Group 4: Mirikizumab Dose 3 for UC
- Group 5: Mirikizumab Dose 7 for UC or CD
- Group 6: Mirikizumab Dose 1 for UC
- Group 7: Mirikizumab Dose 2 for UC
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.
Is this research only testing on elderly patients?
"According to the age requirements needed to join this trial, patients must be aged between 2 and 19."
Answered by AI
What is the status of Mirikizumab's FDA approval process?
"Although it is still in Phase 3 trials, there is already evidence to support the efficacy of Mirikizumab, as well as data from multiple rounds of safety trials. Therefore, we have given it a score of 3."
Answered by AI
Is this research the initial step in this area of study?
"Eli Lilly and Company sponsored the initial clinical trial for Mirikizumab in 2018. 1281 patients were involved and the Phase 3 drug approval stage was completed. 20 studies have been conducted in the years since 2018, with 7 studies still ongoing in 40 countries and 656 cities."
Answered by AI
Are there any specific medical requirements to join this clinical trial?
"Children and adolescents between the ages of 2 and 19 who suffer from inflammatory bowel diseases are eligible for this study, of which there are 150 openings."
Answered by AI
Are there many research papers that have been published about Mirikizumab?
"The immunotherapy drug, mirikizumab, was first studied in Salzburg, Austria in 2018. There have been 20 completed studies on the drug since then, with 7 more ongoing. A large number of these trials take place in Waltham, Massachusetts."
Answered by AI
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