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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis (SHINE-1 Trial)

Phase 2
Waitlist Available
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 predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
Awards & highlights

SHINE-1 Trial Summary

This trial will study how well the body processes and removes mirikizumab in children with UC, as well as the drug's safety and effectiveness. The trial will last about a year and include up to 18 visits.

Eligible Conditions
  • Ulcerative Colitis

SHINE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose on week 4, 8, 12,16, 24, 36, 52 and post dose on week 0 and 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK): Clearance of Mirikizumab
Secondary outcome measures
Change From Baseline in 7-day Average of Abdominal Pain NRS Score at Week 52
Change From Baseline in 7-day Average of Abdominal Pain Numeric Rating Scale (NRS) Score at Week 12
Change From Baseline in Body Weight
+9 more

SHINE-1 Trial Design

9Treatment groups
Experimental Treatment
Group I: Open Label Maintenance Period: Non-Responders: 300 mg Miri IV /200 mg Miri SCExperimental Treatment1 Intervention
Participants (>40 kg) who were non responders to miri at week 12 in induction received 300 mg SC Q4W for 12 weeks or discontinued after repeat induction, then received 200 mg miri SC Q4W through week 48 or until loss of response was confirmed.
Group II: Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/100 mg Miri SCExperimental Treatment1 Intervention
Participants (≤40 kg) who were non responders to miri at week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 100 mg miri (>20 to ≤40 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Group III: Open Label Maintenance Period: Non-Responders: 10 mg/kg Miri IV/ 50 mg Miri SCExperimental Treatment1 Intervention
Participants (≤40 kg) who were non responders to miri at Week 12 in induction received 10 mg SC Q4W for 12 weeks or discontinued after repeat induction, and then received 50 mg miri (≤20 kg weight) SC Q4W through week 48 or until loss of response was confirmed.
Group IV: Open Label Maintenance Period: 50 mg Miri subcutaneous (SC)Experimental Treatment1 Intervention
Participants (≤20 kg weight) who were responders to mirikizumab at week 12 in induction received 50 mg subcutaneously (SC) Q4W from week 12 through week 48 or until loss of response was confirmed.
Group V: Open Label Maintenance Period: 200 mg Miri SCExperimental Treatment1 Intervention
Participants (>40 kg weight) who were responders to mirikizumab at week 12 in induction received 200 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Group VI: Open Label Maintenance Period: 100 mg Miri SCExperimental Treatment1 Intervention
Participants (>20 to ≤40 kg weight) who were responders to mirikizumab at week 12 in induction received 100 mg SC Q4W from week 12 through week 48 or until loss of response was confirmed.
Group VII: Open Label Induction Period: 300 mg Miri IVExperimental Treatment1 Intervention
Participants (>40 kg weight) received 300 mg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Group VIII: Open Label Induction Period: 10 mg/kg Miri IVExperimental Treatment1 Intervention
Participants (≤40 kg weight) received 10 mg/kg mirikizumab given as an IV infusion Q4W on weeks 0, 4, 8 for 12 weeks.
Group IX: Open Label (OL) Induction Period: 5 milligram per kilogram (mg/kg) Miri intravenous (IV)Experimental Treatment1 Intervention
Participants (≤40 kg weight) received 5 mg/kg mirikizumab given as an IV infusion every 4 weeks (Q4W) on weeks 0, 4, 8 for 12 weeks.
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
2,614 Previous Clinical Trials
3,200,956 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
4,140 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
405,226 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
3,990 Patients Enrolled for Ulcerative Colitis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals younger than 50 years old admissible to this medical study?

"As outlined in the trial's eligibility requirements, prospective participants must be within the 2-17 year age bracket."

Answered by AI

Is this the inaugural clinical trial utilizing this particular method?

"Since 2018, Eli Lilly and Company has sponsored the study of Mirikizumab. After an initial trial involving 1281 patients in 2018, it earned its Phase 3 drug approval. Now there are 7 trials actively underway across 40 nations and 655 cities."

Answered by AI

What is the overall turnout for this research endeavor?

"Unfortunately, this study has already concluded its recruitment phase. It was initially posted on May 18th 2020 and the last update happened on August 17th 2022. If you are still interested in participating in a colitis trial, 406 studies remain open for enrolment. Additionally, 7 trials related to Mirikizumab are actively recruiting participants."

Answered by AI

What other investigations have been conducted to analyze the effectiveness of Mirikizumab?

"Mirikizumab was initially trialed in 2018 at the Universitätsklinikum Salzburg. Subsequently, 20 clinical trials have been finished and presently there are 7 studies actively recruiting participants – many of which are hosted by Columbus Ohio's medical centres."

Answered by AI

Is this clinical experiment still accepting new participants?

"This research is not currently recruiting; the trial was initially posted on May 18th 2020 and last updated August 17th 2022. There are 406 trials searching for participants with colitis, and 7 studies employing Mirikizumab actively seeking patients to join their clinical study."

Answered by AI

Is it feasible for me to partake in this clinical experiment?

"The parameters of this medical trial encompass children aged 2 to 17 with colitis. Essential criteria include: a Modified Mayo Score (MMS) within 14 days prior to the initial dose, evidence that UC has spread proximal from the rectum, bodyweight above 10 kgs, and indications of an inadequate response or intolerance to corticosteroids, immunomodulators, JAK inhibitors or biologic therapies for ulcerative colitis over 3 months before beginning medication."

Answered by AI

Where in North America has this clinical trial been implemented?

"Participating in this research are 25 trial sites, including The Abbigail Wexner Research Institute at Nationwide Children's Hospital (Columbus), the Children's Center for Digestive Health Care LLC (Atlanta) and Cincinnati Childrens Hospital Medical Centre (Cincinnati). Additionally, there are other 22 clinical centres involved."

Answered by AI

Has Mirikizumab received the green light from the FDA?

"Mirikizumab's safety was assessed and scored a 2, due to the data available being limited to clinical trials of Phase 2."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
2020. "A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04004611.
~5 spots leftby Apr 2025
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