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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis

Phase 3
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
Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug, Mirikizumab, for people with ulcerative colitis who haven't responded well to other treatments.

Who is the study for?
This trial is for people who've had ulcerative colitis (UC) for at least 3 months and haven't responded well to or can't tolerate standard UC treatments. Women must agree to use contraception. It's not open to those who've had a colectomy, have toxic megacolon, previous treatment with certain antibodies, or are diagnosed with Crohn's disease.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Mirikizumab in treating moderately to severely active UC compared to a placebo. Participants will be randomly assigned either the drug or placebo without knowing which one they receive.See study design
What are the potential side effects?
Possible side effects of Mirikizumab may include allergic reactions, injection site reactions, infections due to weakened immune response, headaches, and potential risks that are currently unknown.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ulcerative colitis is moderate to severe, confirmed by a specific score.

Timeline

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

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 Clinical Remission at Week 12
Secondary outcome measures
Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Leukocyte L1 Antigen Complex
Inflammatory Bowel Diseases
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 300 mg Mirikizumab IV Q4W ME2Experimental Treatment1 Intervention
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Group II: 300 Milligram (mg) Mirikizumab IV Q4WExperimental Treatment1 Intervention
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Group III: Placebo IV Q4W Maximum Extended Enrollment (ME2)Placebo Group1 Intervention
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Group IV: Placebo Intravenous (IV) Every 4 Weeks (Q4W)Placebo Group1 Intervention
Placebo given as an IV infusion 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
2,621 Previous Clinical Trials
3,215,341 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
2,885 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
414,464 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,735 Patients Enrolled for Ulcerative Colitis

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03518086 — Phase 3
Ulcerative Colitis Research Study Groups: 300 mg Mirikizumab IV Q4W ME2, Placebo IV Q4W Maximum Extended Enrollment (ME2), Placebo Intravenous (IV) Every 4 Weeks (Q4W), 300 Milligram (mg) Mirikizumab IV Q4W
Ulcerative Colitis Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT03518086 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03518086 — Phase 3

Frequently Asked Questions

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

Has the FDA greenlit Mirikizumab for therapeutic use?

"There is both pre-existing data supporting the efficacy of Mirikizumab as well as multiple rounds of data affirming its safety; thus, it received a score of 3."

Answered by AI

Would elderly patients be applicable for this clinical research?

"According to the eligibility requirements listed on the website, individuals aged 18 to 80 may apply for this clinical trial. There are 73 other trials for patients under 18 and 369 for patients over 65."

Answered by AI

What are the efficacy goals of this clinical trial?

"The primary goals of this study are to evaluate the percentage of participants in clinical remission and histologic remission at Week 12. Additionally, the study will measure change from baseline to Week 12 in health-related quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ)."

Answered by AI

Could I possibly qualify to be a part of this experimental program?

"The study is looking for 1281 ulcer patients aged 18 to 80. Most importantly, patients must confirm that they have moderately or severely active UC, as assessed by the modified Mayo score (MMS). In addition, patients must demonstrate an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC."

Answered by AI

Does this clinical trial use new methods or treatments?

"As of right now, there are 7 ongoing studies for Mirikizumab in 40 different countries. The first clinical trial for this medication was conducted in 2018 by Eli Lilly and Company. 1281 patients were involved in the study, which successfully completed its Phase 3 drug approval stage. Since then, 18280 more trials have been completed."

Answered by AI

Could you please tell us what other research has been done on Mirikizumab?

"There are 7 active trials studying Mirikizumab at the moment, 6 of which are in Phase 3. Most of the studies for Mirikizumab are located in Warszawa and Guangdong, but there are 2937 locations operating clinical trials for Mirikizumab in total."

Answered by AI

Are researchers actively enrolling new participants for this experiment?

"The study, which was created on 6/18/2018, is still recruiting patients as of 10/26/2022 according to the information available on clinicaltrials.gov."

Answered by AI

Who else is applying?

What site did they apply to?
Life Medical Center & Research, Inc
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
2018. "An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03518086.
All > North Dakota > Colitis
~187 spots leftby May 2025
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