Mirikizumab for Crohn's Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russian FederationCrohn's DiseaseMirikizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Crohn's Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Week 52

Baseline to Week 52
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)
Baseline, Week 12
Change from Baseline in C-Reactive Protein
Change from Baseline in Fecal Calprotectin
Week 52
Percentage of Participants Achieving Clinical Remission
Percentage of Participants Achieving Clinical Response
Percentage of Participants Achieving Endoscopic Remission
Percentage of Participants Achieving Endoscopic Response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Mirikizumab IV and SC
1 of 2
Mirikizumab SC
1 of 2

Experimental Treatment

778 Total Participants · 2 Treatment Groups

Primary Treatment: Mirikizumab · No Placebo Group · Phase 3

Mirikizumab IV and SC
Drug
Experimental Group · 1 Intervention: Mirikizumab · Intervention Types: Drug
Mirikizumab SC
Drug
Experimental Group · 1 Intervention: Mirikizumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirikizumab
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,479 Previous Clinical Trials
3,138,844 Total Patients Enrolled
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)Study DirectorEli Lilly and Company
8 Previous Clinical Trials
2,368 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.