LY4268989 + Mirikizumab for Ulcerative Colitis

(TOPAZ-UC Trial)

Recruiting at 149 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Crohn's disease, Recent infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 104 weeks

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for people with ulcerative colitis (UC), a condition that causes inflammation and sores in the colon. Researchers aim to determine if combining a new drug, LY4268989 (an experimental treatment), with an existing treatment, mirikizumab, is more effective than using mirikizumab alone. Participants will receive either both treatments or mirikizumab with a placebo. People with moderately to severely active UC who have not responded well to other medications might be a good fit for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have an inadequate response or intolerance to certain medications, which might imply some changes to your current treatment. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that mirikizumab is safe. Research indicates that it remains safe for people with ulcerative colitis even after two years. Most patients tolerate it well, with few serious side effects reported. Common reactions include mild issues like headaches or colds, similar to those caused by many other medications.

For LY4268989, the evidence is less clear due to limited study compared to mirikizumab. The study is in an early phase, and researchers are still collecting safety data. This phase primarily assesses the treatment's safety for use, so some uncertainty remains. Participants should be aware that early studies focus heavily on monitoring for any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of LY4268989 and Mirikizumab for ulcerative colitis because it offers a fresh approach compared to current treatments like anti-TNF therapies and Janus kinase inhibitors. LY4268989 introduces a new active ingredient administered orally, which could simplify treatment regimens. Mirikizumab, delivered intravenously and then subcutaneously, targets the IL-23 pathway, potentially providing a more targeted and effective immune response. This novel combination aims to improve efficacy and safety, addressing unmet needs in ulcerative colitis management.

What evidence suggests that this trial's treatments could be effective for ulcerative colitis?

Research has shown that mirikizumab, one of the treatments in this trial, effectively treats ulcerative colitis (UC). Studies found that 78% of patients using mirikizumab remained in remission for four years without corticosteroids, and patients experienced a 55% decrease in urgent bowel movements. In this trial, some participants will receive mirikizumab with a placebo for LY4268989. Although information on LY4268989 is limited, researchers are exploring its combination with mirikizumab in another treatment arm to potentially enhance these results. The aim is to determine if adding LY4268989 can lead to even better outcomes for people with UC. ^{2 4 6 7 8}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with moderately to severely active ulcerative colitis can join this trial. Specific details about who can or cannot participate are not provided, but typically participants must meet certain health criteria and may be excluded based on other medical conditions or treatments.

Inclusion Criteria

I follow the recommended schedule for colorectal cancer checks.

I have been diagnosed with ulcerative colitis for over 3 months, confirmed by endoscopy and biopsy.

My ulcerative colitis is moderate to severe, with recent confirmation.

Exclusion Criteria

I have had or will need surgery on my intestines or abdomen.

I have been diagnosed with Crohn's disease, IBD unclassified, or primary sclerosing cholangitis.

I have severe colon issues that cannot be checked with a standard scope.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4268989 with mirikizumab or mirikizumab alone for ulcerative colitis

104 weeks

Up to 21 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY4268989
• Mirikizumab

Trial Overview The trial is testing the effectiveness and safety of LY4268989 when used together with mirikizumab versus using mirikizumab alone in treating ulcerative colitis. Participants will receive treatment for 104 weeks and attend up to 21 visits over approximately 114 weeks.

How Is the Trial Designed?

Group I: Mirikizumab + LY4268989 Placebo Experimental Treatment 2 Interventions

Mirikizumab administered IV, then SC + LY4268989 placebo administered PO. Responders and Non-responders will re-randomized for Study Period 2.

Group II: LY4268989 + Mirikizumab Experimental Treatment 2 Interventions

LY4268989 administered orally (PO) + Mirikizumab administered intravenously (IV), then subcutaneously (SC). Responders will be re-randomized for Study Period 2.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07186101

Study Details | NCT07186101 | LY4268989 (MORF-057) ... The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult ...

2. prnewswire.com prnewswire.com/news-releases/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained-improvement-in-bowel-urgency-outcomes-for-patients-with-ulcerative-colitis-302594395.html

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and ... Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis.

3. hcplive.com hcplive.com/view/lucent-3-mirikizumab-omvoh-shows-sustained-benefit-ulcerative-colitis-through-4-years

LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit ... Mirikizumab achieved sustained long-term outcomes in UC, with 78% achieving corticosteroid-free clinical remission over four years. The study ...

4. biospace.com biospace.com/press-releases/lillys-omvoh-mirikizumab-mrkz-is-the-first-and-only-il-23p19-antagonist-to-show-four-years-of-sustained-corticosteroid-free-comprehensive-patient-outcomes-in-ulcerative-colitis

Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL ... Approximately 80% of Omvoh-treated patients in the LUCENT-3 study who achieved clinical remission at one year maintained long-term, ...

5. clival.com clival.com/news/eli-lilly-reports-positive-data-on-omvoh-in-ulcerative-colitis-patients

Eli Lilly Reports Positive Data on Omvoh in Ulcerative ... Reduced by 52% at Week 28. · Patients reported a 55% reduction in the number of bowel urgency episodes per day. · delay bowel movement for at ...

6. firstwordpharma.com firstwordpharma.com/story/6314983

Lilly's Omvoh (mirikizumab-mrkz) is the first and only IL ... Approximately 80% of Omvoh-treated patients in the LUCENT-3 study who achieved clinical remission at one year maintained long-term, ...

7. lilly.gcs-web.com lilly.gcs-web.com/news-releases/news-release-details/lillys-omvoh-mirikizumab-mrkz-demonstrated-early-and-sustained

Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained ... Lilly's Omvoh (mirikizumab-mrkz) demonstrated early and sustained improvement in bowel urgency outcomes for patients with ulcerative colitis. October 27 ...

8. trial.medpath.com trial.medpath.com/clinical-trial/41ea76fb0b7dd551/nct07186101-ly4268989-mirikizumab-ulcerative-colitis

LY4268989 (MORF-057) Co-Administered With Mirikizumab ... The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult ...