Ulcerative Colitis

Recruiting

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

I6T-MC-AMAP - ClinicalTrials.gov - NCT03519945

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).
How long will I be in the trial?
The study will last about 176 weeks and may include up to 43 visits.
Email
Recruiting

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

I6T-MC-AMAP - ClinicalTrials.gov - NCT03519945

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).
How long will I be in the trial?
The study will last about 176 weeks and may include up to 43 visits.
Email

Key Requirements

Age :

18-80

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18-80

Sex

All

Participants must

Participants must have completed Studies AMAC (NCT02589665) or AMBG (NCT03524092), received study drug, and did not stop study drug early - Female participants must agree to contraception requirements

Participants must NOT

Participants must not have developed a new condition, including cancer, in the originator study

Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study

Participants must not have received surgery for UC in the originator study and must not be likely to require surgery for treatment of UC during this study

Participants must not have developed growths, known as polyps, that develop on the lining of the large intestine during the originator study that have not been removed prior to the start of this study

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

no

Enrollment Goal

840

Trial Dates

July 2018 - August 2023

Trial Phase

3

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Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18-80

Sex

All

Participants must

Participants must have completed Studies AMAC (NCT02589665) or AMBG (NCT03524092), received study drug, and did not stop study drug early - Female participants must agree to contraception requirements

Participants must NOT

Participants must not have developed a new condition, including cancer, in the originator study

Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study

Participants must not have received surgery for UC in the originator study and must not be likely to require surgery for treatment of UC during this study

Participants must not have developed growths, known as polyps, that develop on the lining of the large intestine during the originator study that have not been removed prior to the start of this study

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

no

Enrollment Goal

840

Trial Dates

July 2018 - August 2023

Trial Phase

3

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Trial Locations

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Ulcerative Colitis Resources

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Crohn's + Ulcerative Colitis Research

New treatments for Crohn’s Disease and Ulcerative Colitis cannot be developed without clinical trial volunteers. By volunteering to participate, you may be able to make important contributions to scientific research. Each clinical trial is different, but the information provided below can help you consider whether a clinical trial may be right for you.
Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?