Multiple Drugs for Ulcerative Colitis or Crohn's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new treatments for individuals with ulcerative colitis or Crohn's disease, conditions that cause inflammation in the digestive tract. The focus is on evaluating the effectiveness and safety of these treatments for those with moderate to severe symptoms. Participants will receive either mirikizumab alone or a combination of LY4395089 (an experimental treatment) and mirikizumab. This trial may suit those who have had ulcerative colitis or Crohn's disease for at least three months and have not found success with other treatments like steroids or advanced therapies. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop your current medications, but it mentions that certain medications are prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mirikizumab, one of the treatments under study, proved safe in past trials. Studies have examined its use for up to four years in individuals with ulcerative colitis and Crohn's disease. These studies found that many patients remained symptom-free without needing steroids, and the treatment was generally well-tolerated. Importantly, no major safety issues emerged during this time.
For LY4395089, less information is available because it is still under testing and not yet approved by the FDA. This trial is in an early stage (Phase 2), meaning researchers are still assessing its safety and effectiveness. While some safety data exist, further testing is necessary to confirm its safety.
In summary, mirikizumab has shown positive safety results in past studies, while LY4395089 remains under investigation. Participants considering joining the trial should know that mirikizumab appears promising in terms of safety, while LY4395089 is still under close examination.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for ulcerative colitis and Crohn's disease because they offer new ways to tackle these conditions. Unlike standard treatments like corticosteroids and immunosuppressants, Mirikizumab is a monoclonal antibody that targets the p19 subunit of IL-23, potentially offering a more targeted approach to inflammation. The co-administration of LY4395089 with Mirikizumab introduces an oral component to the treatment, which could enhance convenience and effectiveness. This combination approach could lead to more personalized and efficient treatment, potentially improving patient outcomes and quality of life.
What evidence suggests that this trial's treatments could be effective for ulcerative colitis or Crohn's disease?
Research has shown that mirikizumab, one of the treatments in this trial, effectively treats both ulcerative colitis and Crohn's disease. Studies indicate that about 63% of patients with ulcerative colitis experienced symptom improvement. For Crohn's disease, mirikizumab helped over 80% of patients maintain relief from symptoms like the urgent need to use the bathroom. In this trial, some participants will receive mirikizumab alone, while others will receive a combination of mirikizumab and LY4395089. Early results suggest that the combination might be more effective, as LY4395089 outperformed a placebo in other studies. Overall, mirikizumab has demonstrated long-lasting benefits and is generally well-tolerated by patients with moderate to severe conditions.16789
Who Is on the Research Team?
Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
This trial is for adults who have had Crohn's disease or ulcerative colitis for at least 3 months and whose condition is moderately to severely active. Participants must have tried certain standard treatments that didn't work well enough, stopped working, or caused side effects.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either mirikizumab or a combination of LY4395089 and mirikizumab for at least 62 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4395089
- Mirikizumab
Trial Overview
The study tests new drugs (LY4395089 and Mirikizumab given by IV or injection) in people with moderate to severe Crohn's disease or ulcerative colitis. Participants are randomly assigned to different treatment groups. The study lasts at least 62 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.
Study Period 1: mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Citations
Mirikizumab in ulcerative colitis: real-world evidence from an ...
Mirikizumab was effective for inducing clinical response and well-tolerated in a substantial cohort of treatment-experienced patients with UC.
Study Details | NCT07483073 | A Master Protocol (IIBD) ...
Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop ...
Two-Year Data Show Long-Term Benefits of Mirikizumab in ...
Following continuous treatment with mirikizumab, results showed 92.9% of patients who were in clinical remission (measured by Crohn's Disease ...
Results From the LUCENT-3 Open-Label Extension Study
3-year continuous treatment with mirikizumab maintained clinical remission in most induction clinical responders, regardless of previous biologic failure ...
Mirikizumab Demonstrates Sustained Disease Clearance ...
Mirikizumab Demonstrates Sustained Disease Clearance Through 4 Years in Ulcerative Colitis ... Long-term results from the LUCENT clinical trial ...
6.
appliedclinicaltrialsonline.com
appliedclinicaltrialsonline.com/view/mirikizumab-trial-disease-clearance-ulcerative-colitisMirikizumab Trial Extension Data Show 4-Year Disease ...
LUCENT-3 trial open-label extension data show 63.5% of adults with ulcerative colitis administered mirikizumab (Omvoh) who achieved disease ...
LY4395089: Uses, Side Effects, Dosing & 2 Clinical Trials
LY4395089 is an investigational drug, meaning it is currently being studied in clinical trials and is not yet approved by the FDA for any ...
Efficacy and safety of Mirikizumab for ulcerative colitis - PMC
Mirikizumab demonstrates significant efficacy in treating UC, substaintially improving clinical, endoscopic, and histological outcomes.
9.
lilly.gcs-web.com
lilly.gcs-web.com/news-releases/news-release-details/patients-crohns-disease-maintained-steroid-free-remission-threePatients with Crohn's disease maintained steroid-free ...
Landmark VIVID-2 data showed more than 90% of patients who achieved steroid-free remission at one year maintained steroid-free control ...
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