Recruiting

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

I6T-MC-AMBG - ClinicalTrials.gov - NCT03524092

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
How long will I be in the trial?
The study will last about 40 weeks and may include up to 11 visits.
Email
Recruiting

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

I6T-MC-AMBG - ClinicalTrials.gov - NCT03524092

The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
How long will I be in the trial?
The study will last about 40 weeks and may include up to 11 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 Study AMAN (NCT03518086), received study drug, and without early termination of study drug

Participants must be willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry

Female participants must meet the contraception (birth control) requirements

Participants must NOT

Participants must not have had surgery to remove part of the bowel or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086) and must not be likely to require surgery for the treatment of UC during study AMBG

Participants must not have evidence of abnormal cells in the colon or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086)

Participants must not be diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086)

Participants must not initiate a new medication that was not allowed during the induction study AMAN (NCT03518086)

Participants must not have certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

1044

Trial Dates

October 2018 - June 2023

Trial Phase

3

Enter your postal code to find the nearest site

Think this trial might be a good fit for you?

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 Study AMAN (NCT03518086), received study drug, and without early termination of study drug

Participants must be willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry

Female participants must meet the contraception (birth control) requirements

Participants must NOT

Participants must not have had surgery to remove part of the bowel or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086) and must not be likely to require surgery for the treatment of UC during study AMBG

Participants must not have evidence of abnormal cells in the colon or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086)

Participants must not be diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086)

Participants must not initiate a new medication that was not allowed during the induction study AMAN (NCT03518086)

Participants must not have certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug

Trial Summary

Conditions the trial is for

Ulcerative Colitis

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

1044

Trial Dates

October 2018 - June 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?