Active not recruiting

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)

I6T-MC-AMAG - ClinicalTrials.gov - NCT02891226

The purpose of this study is to evaluate the safety and effectiveness of the study drug LY3074828 in participants with active Crohn's Disease.
How long will I be in the trial?
Your participation could last approximately 2 years and include 35 visits to the study center
Email
Active not recruiting

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease (SERENITY)

I6T-MC-AMAG - ClinicalTrials.gov - NCT02891226

The purpose of this study is to evaluate the safety and effectiveness of the study drug LY3074828 in participants with active Crohn's Disease.
How long will I be in the trial?
Your participation could last approximately 2 years and include 35 visits to the study center
Email

Key Requirements

Age :

18-75

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

18-75

Sex

All

Participants must

Participant must have active Crohn's Disease (i.e., currently having a flare, or experiencing symptoms)

Participant must have had inadequate response or failure to tolerate at least one of the following: amino salicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of Crohn's Disease

Participants must NOT

Participant must not have complications of Crohn's Disease such as strictures, stenosis, or any other manifestation for which surgery might be indicated

Participant must not have a diagnosis of any condition affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome

Participant must not have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening

Trial Summary

Conditions the trial is for

Crohn's Disease

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

180

Trial Dates

December 2016 - November 2020

Trial Phase

2

Enter your postal code to find the nearest site

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

18-75

Sex

All

Participants must

Participant must have active Crohn's Disease (i.e., currently having a flare, or experiencing symptoms)

Participant must have had inadequate response or failure to tolerate at least one of the following: amino salicylates; budesonide; systemic corticosteroids; immunosuppressants (eg, azathioprine, 6-mercaptopurine, or methotrexate); or prior exposure to biologics for the treatment of Crohn's Disease

Participants must NOT

Participant must not have complications of Crohn's Disease such as strictures, stenosis, or any other manifestation for which surgery might be indicated

Participant must not have a diagnosis of any condition affecting the digestive tract, such as ulcerative colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess, adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel syndrome

Participant must not have had any kind of bowel resection, diversion, or placement of a stoma within 6 months or any other intra-abdominal surgery within 3 months prior to screening

Trial Summary

Conditions the trial is for

Crohn's Disease

What the trial is testing?

Mirikizumab

Could I receive a Placebo?

yes

Enrollment Goal

180

Trial Dates

December 2016 - November 2020

Trial Phase

2

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Trial Locations

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Crohn's Disease 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?