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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis

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
Female participants must agree to contraception requirements
Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 160
Awards & highlights

Study Summary

This trial will study the effects of mirikizumab on people with UC. It will evaluate how well it works and how safe it is.

Who is the study for?
This trial is for people with moderate to severe ulcerative colitis who were previously in studies AMAC or AMBG and received at least one dose of the study drug without early termination. Women must agree to use contraception. Those with significant infections like hepatitis or HIV, recent UC surgery, new conditions such as cancer, or unremoved adenomatous polyps can't join.Check my eligibility
What is being tested?
The trial is testing Mirikizumab's long-term effectiveness and safety in treating ulcerative colitis. Participants are those who have already been part of earlier related trials and will continue to receive this medication over an extended period.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like Mirikizumab may include injection site reactions, increased risk of infection, headaches, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to follow the study's birth control requirements.
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I was in Study AMAC or AMBG, received at least one treatment, and did not stop the study drug early.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 160
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 160 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 in Clinical Remission
Secondary outcome measures
Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Percentage of Participants Who Undergo UC Surgeries Including Colectomy
Percentage of Participants Who are Hospitalized Due to UC
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: MirikizumabExperimental Treatment1 Intervention
Mirikizumab administered subcutaneously (SC).
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
2,618 Previous Clinical Trials
3,200,497 Total Patients Enrolled
8 Trials studying Ulcerative Colitis
3,103 Patients Enrolled for Ulcerative Colitis
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
404,691 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
2,953 Patients Enrolled for Ulcerative Colitis

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03519945 — Phase 3
Ulcerative Colitis Research Study Groups: Mirikizumab
Ulcerative Colitis Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT03519945 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03519945 — Phase 3

Frequently Asked Questions

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

May I join this clinical research study?

"Eligible patients for this clinical trial must suffer from colitis and be between 18-80 years old. In total, 960 individuals are being recruited for the study."

Answered by AI

What are the possible side effects of Mirikizumab?

"There is already some data affirming the efficacy of Mirikizumab as well as numerous rounds of safety testing, so it received a 3."

Answered by AI

What are the precedents for this research?

"Since 2018, global researchers have been studying the effects of Mirikizumab. After a Phase 1 trial in 2018 with 1281 participants, Eli Lilly and Company sponsored a follow-up study which resulted in the drug's approval for Phase 3 testing. 7 different active studies are being conducted as of now, located in 40 countries across 656 cities."

Answered by AI

How many different places are coordinating this clinical trial?

"There are 69 different clinical trial sites where patients can receive treatment for this condition. Some of these locations include Washington Gastroenterology, PLLC in Tacoma, Lee Memorial Hospital in Great Neck, and Texas Digestive Disease Consultants in Dallas."

Answered by AI

What is known about Mirikizumab from other research?

"Currently, there are 7 clinical trials studying the efficacy of Mirikizumab. Phase 3 is the most advanced level of testing and 6 out of the 7 ongoing trials are in this stage. Most of these tests are conducted in Warszawa and New South Wales; however, 2942 locations across the world are running similar investigations."

Answered by AI

If a patient is above the age of 85, are they still eligible for this clinical trial?

"Only patients aged 18-80 who meet the other qualifications can apply to this trial. Out of 441 total studies, 74 are for people under 18 and 367 are for those over 65."

Answered by AI

Are they still enrolling people in this clinical trial?

"This particular clinical trial, which was last updated on November 9th 2022, is no longer recruiting patients. However, 431 other trials are ongoing and actively seeking new participants."

Answered by AI

How many individuals can join this trial at its most full?

"Recruitment for this clinical trial has concluded. The study was first posted on July 18th, 2018 and received its last update November 9th, 2022. However, there are 424 other studies involving colitis and 7 trials utilising Mirikizumab that are actively searching for participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Alabama
How old are they?
18 - 65
65+
What site did they apply to?
Wellness Clinical Research
GI Alliance Research Baton Rouge
Nola Research Works, LLC
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
2018. "A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03519945.
All > Inflammatory Bowel Disease > Colitis
~291 spots leftby Jul 2026
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