What is the mechanism of action of this treatment?

The most common treatments for Ulcerative Colitis (UC) include 5-aminosalicylates (5-ASA), glucocorticoids, and biologic therapies like IL-23 inhibitors. 5-ASA medications, such as mesalamine, work by reducing inflammation in the lining of the colon, which helps maintain remission. Glucocorticoids, like prednisone, are used for their potent anti-inflammatory effects but are not suitable for long-term use due to side effects. IL-23 inhibitors, such as Mirikizumab, target the interleukin-23 pathway, which plays a crucial role in the inflammatory process of UC. By inhibiting IL-23, these biologics can reduce inflammation and help achieve and maintain remission. Understanding these mechanisms is vital for UC patients as it helps tailor treatment plans to effectively manage their condition and improve their quality of life.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis include IL-23 inhibitors like Mirikizumab, 5-aminosalicylic acid (5-ASA) agents, glucocorticoids, and TNF inhibitors. IL-23 inhibitors can cause infections, injection site reactions, and headaches. 5-ASA agents may lead to nausea, headache, fever, rash, and rarely, pancreatitis or pneumonitis. Glucocorticoids are associated with a wide range of side effects including weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. TNF inhibitors can cause infusion reactions, increased risk of infections, and potential development of antibodies against the drug, reducing its effectiveness.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Ulcerative Colitis include several biologic agents targeting different inflammatory pathways. Notably, Ustekinumab, an IL-12/23 inhibitor, has been approved for moderate to severe UC. Other biologics such as anti-TNF agents (e.g., Infliximab, Adalimumab) and anti-integrin agents (e.g., Vedolizumab) have also been approved for UC. These treatments aim to reduce inflammation and maintain remission in patients with UC.

What other types of research exist?

Promising alternatives to Mirikizumab for Ulcerative Colitis patients include: <ol> <li>Ustekinumab (IL-12/23 Inhibition) - Effective for induction and maintenance of remission in Crohn's disease and potentially UC.</li> <li></li> </ol> Vedolizumab (Integrin Inhibition) - Shown efficacy in moderately to severely active UC. 3. Infliximab and Adalimumab (TNF Inhibitors) - Proven efficacy in inducing and maintaining remission in UC. 4. Certolizumab Pegol (TNF Inhibition) - Effective in Crohn's disease and may be considered for UC.

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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis (LUCENT-URGE Trial)

Phase 3

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called mirikizumab, which aims to reduce bowel urgency in adults with severe ulcerative colitis. The medication works by calming the immune system to reduce inflammation in the intestines. The study will last for several months and include multiple phases.

Who is the study for?

This trial is for adults with moderately to severely active ulcerative colitis who have had it for at least 3 months. They should be experiencing bowel urgency and not responding well to conventional or certain advanced therapies. People with Crohn's disease, limited rectal disease, gastrointestinal cancer history, tuberculosis, HIV, or specific immunodeficiency syndromes cannot join.

What is being tested?

The study tests Mirikizumab's effect on bowel urgency in people with moderate to severe ulcerative colitis. It spans over 36 weeks and includes four different periods of assessment to understand how well the treatment works.

What are the potential side effects?

While the specific side effects are not listed here, similar medications often cause immune system reactions, infections risk increase, potential liver issues and may affect blood cells leading to various symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 3 trial • 530 Patients • NCT03482011

14%

Nasopharyngitis

Headache

Upper respiratory tract infection

Injection site pain

Pelvic inflammatory disease

Back pain

Dysmenorrhoea

Arthralgia

Dermatitis contact

Hypertension

Pharyngitis

Urinary tract infection

Oedema peripheral

Folliculitis

Oral herpes

Contusion

Hypertriglyceridaemia

Osteoarthritis

Injection site reaction

Bronchitis

Meniscus injury

Blood pressure increased

Cough

Pruritus

Toothache

Weight increased

Musculoskeletal chest pain

Pain in extremity

Oropharyngeal pain

Tonsillitis

Rhinitis allergic

Groin pain

Erysipelas

Respiratory tract infection

Leukocytosis

Cardiac failure chronic

Food poisoning

Gastrointestinal disorder

Gingival atrophy

Chest pain

Injection site erythema

Gastroenteritis viral

Gastrointestinal infection

Pharyngotonsillitis

Hepatic enzyme increased

Overweight

Joint effusion

Pollakiuria

Rhinorrhoea

Dermal cyst

Rash

Urticaria

Wisdom teeth removal

Ingrowing nail

Pain

Arthropod sting

Palpitations

Stomatitis

Injection site induration

Malaise

Otitis media

Paronychia

Tracheitis

Aspartate aminotransferase increased

Joint swelling

Muscle spasms

Rotator cuff syndrome

Erythema

Atrial fibrillation

Glossitis

Injection site pruritus

Ear infection

Animal bite

Wound complication

Blood triglycerides increased

C-reactive protein increased

Electrocardiogram qt prolonged

Gamma-glutamyltransferase increased

Type 2 diabetes mellitus

Facial paralysis

Sinus headache

Dry mouth

Alanine aminotransferase increased

Muscle tightness

Hypoaesthesia

100%

80%

60%

40%

20%

Study treatment Arm

250 mg Miri Q4W Responders to 125 mg Miri Q8W

250 mg Miri Q4W Responder to 250 mg Miri Q8W

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

250mg Miri Q4W to 250mg Miri 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

Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirikizumab

2020

Completed Phase 3

~6070

Do I qualify?Apply below to find out

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 5-aminosalicylates (5-ASA), glucocorticoids, and biologic therapies like IL-23 inhibitors. 5-ASA medications, such as mesalamine, work by reducing inflammation in the lining of the colon, which helps maintain remission. Glucocorticoids, like prednisone, are used for their potent anti-inflammatory effects but are not suitable for long-term use due to side effects. IL-23 inhibitors, such as Mirikizumab, target the interleukin-23 pathway, which plays a crucial role in the inflammatory process of UC. By inhibiting IL-23, these biologics can reduce inflammation and help achieve and maintain remission. Understanding these mechanisms is vital for UC patients as it helps tailor treatment plans to effectively manage their condition and improve their quality of life.