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Monoclonal Antibodies

Mirikizumab for Crohn's Disease (VIVID-2 Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights

VIVID-2 Trial Summary

This trial will evaluate the effectiveness of mirikizumab in treating Crohn's disease.

Who is the study for?
This trial is for people who have Crohn's disease and completed previous studies (NCT02891226 or NCT03926130). Women must follow contraception rules. People with new risks like cancer, known allergies to mirikizumab, severe reactions in past trials, pregnancy, certain infections like hepatitis or HIV/AIDS can't join.Check my eligibility
What is being tested?
The study tests the long-term effects and safety of a drug called Mirikizumab on individuals with Crohn's disease. It aims to see how well it works over an extended period following earlier trials.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of Mirikizumab as part of assessing its safety profile.

VIVID-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 Achieving Clinical Remission
Percentage of Participants Achieving Endoscopic Response
Secondary outcome measures
Change from Baseline in C-Reactive Protein
Change from Baseline in Fecal Calprotectin
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)
+2 more

VIVID-2 Trial Design

2Treatment groups
Experimental Treatment
Group I: Mirikizumab SCExperimental Treatment1 Intervention
Mirikizumab given subcutaneously (SC).
Group II: Mirikizumab IV and SCExperimental Treatment1 Intervention
Mirikizumab given intravenously (IV) and 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
3,200,782 Total Patients Enrolled
Study DirectorEli Lilly and Company
8 Previous Clinical Trials
2,426 Total Patients Enrolled

Media Library

Mirikizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04232553 — Phase 3
Crohn's Disease Research Study Groups: Mirikizumab IV and SC, Mirikizumab SC
Crohn's Disease Clinical Trial 2023: Mirikizumab Highlights & Side Effects. Trial Name: NCT04232553 — Phase 3
Mirikizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04232553 — Phase 3

Frequently Asked Questions

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

Is there a risk of serious side effects from taking Mirikizumab?

"Mirikizumab has received a score of 3 for safety. This is because it is in Phase 3 clinical trials, so there is data supporting both its efficacy and safety from multiple rounds of testing."

Answered by AI

Does this study represent a new approach to research?

"Since 2018, the pharmaceutical company Eli Lilly and Company has been researching mirikizumab. The first study involving 1281 people occurred in 2018. After this initial trial, mirikizumab received Phase 3 drug approval and there are now 7 active studies being conducted across 656 cities and 40 countries."

Answered by AI

What is the precedent for Mirikizumab's efficacy?

"Right now, there are 7 distinct research programs underway for Mirikizumab. Of those, 6 are in the critical third stage of testing. Most of the clinical trials related to Mirikizumab are taking place in Warszawa and New South Wales; however, 2942 different locations around the world are running studies concerning this treatment."

Answered by AI

What are the researchers investigating with this clinical trial?

"The primary outcome being measured by Eli Lilly and Company, the study's sponsor, over the course of 52 weeks is Percentage of Participants Achieving Clinical Remission. Additionally, this trial will evaluate Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ), Percentage of Participants Achieving Endoscopic Remission, and Percentage of Participants Achieving Clinical Response as secondary outcomes."

Answered by AI

To date, how many people have agreed to take part in this research?

"In order to successfully run this trial, 778 patients who meet the pre-specified inclusion criteria are needed. These potential participants can be based out of locations such as Private Practice - Dr. Bruce Musgrave in Kentville, Nova Scotia and Washington University Medical School in Saint Louis, Missouri."

Answered by AI

In how many different medical practices is this medical study being overseen today?

"This study is being conducted out of numerous locations, some of which are Private Practice - Dr. Bruce Musgrave in Kentville, Nova Scotia, Washington University Medical School in Saint Louis, Missouri, and Capital Digestive Care in Rockville, Maryland."

Answered by AI

Are there any opportunities for patients to participate in this research?

"That is correct, the online information from clinicaltrials.gov corroborates that this study is actively looking for subjects to participate. The listing was first posted on 6/22/2020 and updated as recently as 11/10/2022. So far, they have 85 locations signed up but need 778 people total to fill the trial."

Answered by AI

Who else is applying?

What site did they apply to?
Arizona Arthritis & Rheumatology Associates
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
2020. "A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04232553.
All > Paid Studies Wyoming > Crohns Disease
~115 spots leftby Jan 2025
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