What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis, including IL-23 inhibitors like Mirikizumab, can have various side effects. IL-23 inhibitors may cause infections, injection site reactions, and headaches. 5-ASA agents, such as mesalamine, can lead to nausea, headache, fever, rash, and rarely, pancreatitis or pneumonitis. Glucocorticoids are associated with weight gain, osteoporosis, hypertension, and increased infection risk. Anti-TNF agents, like infliximab, can cause infusion reactions, infections, and rarely, lymphoma or heart failure. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several biologic treatments for Ulcerative Colitis, including IL-23 inhibitors like ustekinumab (Stelara), which targets both IL-12 and IL-23. Other biologics include TNF inhibitors such as infliximab (Remicade) and adalimumab (Humira), and integrin inhibitors like vedolizumab (Entyvio). These treatments work by modulating the immune response to reduce inflammation and maintain remission in patients with Ulcerative Colitis.

What other types of research exist?

Promising novel alternatives to Mirikizumab for Ulcerative Colitis patients include: 1) Anti-tumor necrosis factor (TNF) antibodies such as infliximab and adalimumab, which have been effective but may lose efficacy over time. 2) Janus kinase (JAK) inhibitors like tofacitinib, which target intracellular signaling pathways involved in inflammation. 3) Anti-integrin therapies such as vedolizumab, which prevent immune cells from migrating to the gut. 4) Sphingosine-1-phosphate (S1P) receptor modulators, which are emerging as potential treatments by modulating lymphocyte trafficking. Each of these alternatives offers a different mechanism of action, providing options for patients who may not respond to IL-23 inhibition.

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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis

Phase 3

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants must agree to contraception requirements

Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug

Must not have

Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study

Participants must not have developed a new condition, including cancer in the originator study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 160

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing mirikizumab, a medication for people with severe ulcerative colitis. It aims to see if the drug can reduce gut inflammation by blocking a protein that causes it. The study will last several years. Mirikizumab has shown positive results in early tests for ulcerative colitis.

Who is the study for?

This trial is for people with moderate to severe ulcerative colitis who were previously in studies AMAC or AMBG and received at least one dose of the study drug without early termination. Women must agree to use contraception. Those with significant infections like hepatitis or HIV, recent UC surgery, new conditions such as cancer, or unremoved adenomatous polyps can't join.

What is being tested?

The trial is testing Mirikizumab's long-term effectiveness and safety in treating ulcerative colitis. Participants are those who have already been part of earlier related trials and will continue to receive this medication over an extended period.

What are the potential side effects?

While not specified here, common side effects of drugs like Mirikizumab may include injection site reactions, increased risk of infection, headaches, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to follow the study's birth control requirements.

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I was in Study AMAC or AMBG, received at least one treatment, and did not stop the study drug early.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have significant infections like hepatitis or HIV/AIDS.

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I have not developed any new conditions, including cancer, since my original study.

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I have had all adenomatous polyps removed before this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 160

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 160

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 160 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants in Clinical Remission

Secondary study objectives

Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score

Percentage of Participants Who Undergo UC Surgeries Including Colectomy

Percentage of Participants Who are Hospitalized Due to UC

+4 more

Side effects data

From 2020 Phase 3 trial • 530 Patients • NCT03482011

11%

Upper respiratory tract infection

10%

Nasopharyngitis

Injection site pain

Headache

Cough

Pharyngitis

Arthralgia

Gastroenteritis

Salpingo-oophoritis

Diarrhoea

Hepatic steatosis

Bronchitis

Influenza

Dysmenorrhoea

Malaise

Back pain

Hypertension

Aspartate aminotransferase increased

Gout

Oropharyngeal pain

Erectile dysfunction

Pruritus

Toothache

Urinary tract infection

Ligament sprain

Gamma-glutamyltransferase increased

Alanine aminotransferase increased

Tinnitus

Borrelia infection

Drug hypersensitivity

Actinic keratosis

Appendicitis

Weight increased

Oral herpes

Respiratory tract infection

Epilepsy

Dental caries

Periodontal disease

Typhoid fever

Pyrexia

Acne pustular

Bacteriuria

Conjunctivitis bacterial

Gastroenteritis viral

Gastrointestinal infection

Hepatitis e

Pharyngotonsillitis

Pulpitis dental

Hepatic enzyme increased

Weight decreased

Type 2 diabetes mellitus

Osteoarthritis

Spinal pain

Migraine

Rash

Seborrhoeic dermatitis

Tooth extraction

Abdominal pain lower

Injection site induration

Injection site reaction

Hypersensitivity

Bacterial infection

Postoperative wound infection

Skin laceration

Arthropathy

Muscle spasms

Upper-airway cough syndrome

Dermal cyst

Glomerulonephritis membranous

Vertigo

Injection site swelling

Cholecystitis

Cystitis

Erythema migrans

Folliculitis

Molluscum contagiosum

Arthropod bite

Thermal burn

Blood triglycerides increased

Very low density lipoprotein increased

Skin papilloma

Herpes zoster

Procedural pain

Emphysema

100%

80%

60%

40%

20%

Study treatment Arm

250 mg Miri Q4W Responder to 250 mg Miri Q8W

250mg Miri Q4W to 250mg Miri Q8W(Responders) Follow-up Period

250 mg Miri Q4W Responders to 125 mg Miri Q8W

250 mg Miri Q4W to Placebo Q8W (Responders) Follow-up Period

250mg Miri Q4W to 250mg Miri Q8W(Miri Non-Responders)

Placebo Q4W to Placebo Non-Responder-Follow-up Period

250mg Miri Q4W to 125 mg Miri Q8W(Responders) Follow-up Period

250 Miri Q4W Discontinued During Induction-Follow-up

250 Miri Q4W to Miri Nonresponder-Follow-up Period

Placebo Q4W

250 mg Miri Q4W

Placebo Q4W to Placebo Q8W (Placebo Responder)

Placebo Q4W to 250 mg Miri Q4W /Q8W (Placebo Non-Responders)

250 mg Miri Q4W Responders to Placebo Q8W

Relapse

Placebo Q4W to Placebo Q8W (Responder) Follow-up Period

Placebo Q4W Discontinued During Induction-Follow-up Period

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MirikizumabExperimental Treatment1 Intervention

Mirikizumab administered subcutaneously (SC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirikizumab

2020

Completed Phase 3

~6070

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ulcerative Colitis (UC) include biologic therapies such as anti-TNF agents (e.g., infliximab, adalimumab), IL-12/23 inhibitors (e.g., ustekinumab), and IL-23 inhibitors (e.g., mirikizumab). Anti-TNF agents work by blocking tumor necrosis factor-alpha (TNF-α), a cytokine involved in systemic inflammation, thereby reducing inflammation in the colon. IL-12/23 inhibitors target the shared p40 subunit of IL-12 and IL-23, which are cytokines that play a role in the inflammatory response. IL-23 inhibitors like mirikizumab specifically target the p19 subunit of IL-23, reducing the inflammatory response more selectively. These treatments are crucial for UC patients as they help manage chronic inflammation, reduce symptoms, and maintain remission, improving the overall quality of life.

Emerging Therapies for Inflammatory Bowel Diseases.Novel topical therapies for distal colitis.