Eltrekibart + Mirikizumab for Ulcerative Colitis

Recruiting in Palo Alto (17 mi)

+126 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

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.

Trial 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 (Other)
• Mirikizumab (Monoclonal Antibodies)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

United Medical Doctors Los Alamitos, CA

Om Research, LLC Lancaster, CA

Medical Research Center of Connecticut, LLC Hamden, CT

Digestive Disease Consultants DDCJAX Orange Park, FL

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2708

Patients Recruited

3,720,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]