Eltrekibart + Mirikizumab for Ulcerative Colitis

Recruiting at 173 trial locations

Overseen By There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Corticosteroids

Must not be taking: Anti-IL-23p19, Anti-IL-12p40

Disqualifiers: Crohn's disease, Thrombotic event, 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: 1

Duration: 64 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants should be on a stable dose of certain oral UC medications. It seems you may continue some medications, but it's best to confirm with the trial coordinators.

Is the combination of Eltrekibart and Mirikizumab safe for humans?

Mirikizumab, also known as Omvoh, has been shown to have a favorable safety profile in treating ulcerative colitis, similar to other IL-23 antagonists, and has been approved for use in Japan and Europe. ^{1 2 3 4 5}

How is the drug Eltrekibart + Mirikizumab unique for treating ulcerative colitis?

Mirikizumab is unique because it is the first drug approved that targets the IL-23 pathway, specifically the p19 subunit, for treating moderate to severe ulcerative colitis, offering a new option for patients who do not respond to other treatments. ^{1 3 4 5 6}

Research Team

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)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Adults with moderate to severe ulcerative colitis (UC) who haven't responded well to conventional treatments or advanced therapies can join. They must be on a stable oral UC medication dose, have had UC for at least 3 months, and follow contraception rules. People with Crohn's Disease, past anti-IL therapy, certain gastrointestinal diseases, recent thrombotic events or surgeries aren't eligible.

Inclusion Criteria

Must meet contraception requirements

My ulcerative colitis is moderate to severe.

I am on a stable dose of my ulcerative colitis medication.

Exclusion Criteria

I have been treated with anti-IL-23p19 or anti-IL-12p40 antibodies before.

I have been diagnosed with Crohn's Disease or a similar inflammatory bowel condition.

I have a history of specific types of growths or cancers.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

5 weeks

1 visit (in-person)

Treatment

Participants receive eltrekibart and mirikizumab in combination or separately as monotherapy

64 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Eltrekibart
• Mirikizumab

Trial Overview The trial is testing the safety and effectiveness of two drugs: Eltrekibart and Mirikizumab against a placebo in adults with active UC. Participants will receive one of these medications or a placebo to see which is better at managing their symptoms.

Participant Groups

Group I: Placebo Experimental Treatment 2 Interventions

Participants will receive placebo or mirikizumab.

Group II: Mirikizumab + Placebo Experimental Treatment 2 Interventions

Participants will receive mirikizumab and placebo or mirikizumab.

Group III: Eltrekibart + Placebo Experimental Treatment 3 Interventions

Participants will receive eltrekibart with placebo, eltrekibart or mirikizumab.

Group IV: Eltrekibart + Mirikizumab Experimental Treatment 2 Interventions

Participants will receive eltrekibart and mirikizumab in combination or separately as monotherapy.

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

Findings from Research

Mirikizumab, a monoclonal antibody targeting the IL-23 pathway, has been shown to effectively induce and maintain remission in patients with moderately to severely active ulcerative colitis, including those who previously did not respond to other treatments.

This therapy has a favorable safety profile and is the first IL-23 antagonist to receive regulatory approval for ulcerative colitis in Europe, addressing a significant need for new treatment options in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirikizumab for the treatment of moderate to severe ulcerative colitis. Hanzel, J., Ma, C., Jairath, V.[2023]

Mirikizumab, an anti-interleukin-23 treatment, significantly improved histological and endoscopic outcomes in patients with moderately-to-severely active ulcerative colitis, showing better results compared to placebo in a study involving 1162 patients at Week 12 and 544 patients at Week 40.

Achieving early endoscopic and histological improvements with mirikizumab was linked to better long-term outcomes, including clinical remission and reduced symptoms, highlighting the importance of early intervention in managing ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. Magro, F., Pai, RK., Kobayashi, T., et al.[2023]

Mirikizumab, an anti-IL-23p19 monoclonal antibody, was approved in March 2023 in Japan for treating moderate to severe ulcerative colitis, marking it as the first IL-23p19 inhibitor approved for this condition.

In the EU, mirikizumab received a positive opinion for adult patients with active ulcerative colitis who did not respond to conventional or biologic therapies, highlighting its potential as a new treatment option for difficult-to-treat cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirikizumab: First Approval. Keam, SJ.[2023]

In two Phase 3 trials involving 1162 patients for induction and 544 for maintenance, mirikizumab significantly improved bowel urgency in ulcerative colitis patients compared to placebo, with higher rates of clinically meaningful improvement and remission at both 12 and 52 weeks.

Patients who experienced improvement in bowel urgency while on mirikizumab also showed better overall clinical outcomes, including higher rates of clinical remission and improved quality of life, indicating that addressing bowel urgency can enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. Dubinsky, MC., Clemow, DB., Hunter Gibble, T., et al.[2023]

Mirikizumab, an anti-interleukin-23 monoclonal antibody, demonstrated pharmacokinetic properties typical of monoclonal antibodies, with a half-life of approximately 9.5 days and a subcutaneous bioavailability of 48%, based on data from 1362 patients with ulcerative colitis.

The study found that while body weight and serum albumin levels influenced the drug's clearance and distribution, these effects were relatively small compared to individual variability, suggesting that no dose adjustments are necessary based on patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Chua, L., Friedrich, S., Zhang, XC.[2023]

In a study involving patients with moderate to severe ulcerative colitis who initially did not respond to mirikizumab after 12 weeks, 50% of those receiving an additional 12 weeks of 600 mg mirikizumab achieved a clinical response, indicating that extended treatment can be effective for nonresponders.

Among those who responded to the extended treatment, 65.8% maintained their clinical response for up to 52 weeks, demonstrating the long-term efficacy of mirikizumab without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Sandborn, WJ., Ferrante, M., Bhandari, BR., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Mirikizumab for the treatment of moderate to severe ulcerative colitis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. [2023]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Mirikizumab: First Approval. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical Effect of Mirikizumab Treatment on Bowel Urgency in Patients with Moderately to Severely Active Ulcerative Colitis and the Clinical Relevance of Bowel Urgency Improvement for Disease Remission. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. [2022]