Mirikizumab for Ulcerative Colitis
(SHINE-ON Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Mirikizumab for treating ulcerative colitis?
Mirikizumab has been shown to improve quality of life and reduce bowel urgency in patients with moderately to severely active ulcerative colitis, according to results from phase 3 clinical trials. It is also approved in Japan and received a positive opinion in the EU for patients who did not respond well to other treatments.12345
What safety data exists for Mirikizumab in humans?
Mirikizumab has been approved in Japan and received a positive opinion in the EU for treating ulcerative colitis, indicating it has undergone safety evaluations. However, the provided research articles focus on its effectiveness and quality of life improvements rather than specific safety data.12345
How is the drug Mirikizumab unique for treating ulcerative colitis?
Mirikizumab is unique because it is the first drug approved that specifically targets the IL-23p19 protein, which plays a role in inflammation, making it effective for patients who haven't responded well to other treatments. It has shown to significantly reduce bowel urgency, a common and distressing symptom of ulcerative colitis, improving patients' quality of life.14567
What is the purpose of this trial?
This trial is testing a medication called mirikizumab to see if it can help children with ulcerative colitis or Crohn's disease by reducing inflammation in their digestive tracts.
Research Team
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - hours, EST)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various doses of Mirikizumab based on their condition and weight, with potential intravenous rescue dosing if response is lost
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Long-term evaluation of the efficacy and safety of Mirikizumab in pediatric participants
Treatment Details
Interventions
- Mirikizumab
Mirikizumab is already approved in European Union, United States, Canada, Japan for the following indications:
- Moderately to severely active ulcerative colitis
- Moderately to severely active ulcerative colitis
- Moderately to severely active ulcerative colitis
- Moderately to severely active ulcerative colitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University