What side effects are associated with this type of intervention?

Common treatments for Inflammatory Bowel Disease (IBD) such as anti-TNF agents (e.g., infliximab), IL-12/23 inhibitors (e.g., ustekinumab), and IL-17 inhibitors (e.g., secukinumab) share several side effects. These can include increased risk of infections, injection site reactions, and potential development of antibodies against the drug, which may reduce efficacy. Specific to IL-23 inhibitors like Mirikizumab, side effects may also include nasopharyngitis, headache, and upper respiratory infections. It is important to monitor for these adverse effects and discuss them with a healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several biologic therapies for the treatment of Inflammatory Bowel Disease (IBD), including Ulcerative Colitis (UC) and Crohn's Disease (CD). These treatments primarily target inflammatory pathways. Notably, anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol have been approved for both induction and maintenance of remission in CD. Additionally, ustekinumab, which targets IL-12 and IL-23, has been approved for patients who have failed other biologic therapies. Mirikizumab, currently under study, specifically targets IL-23, similar to ustekinumab, and aims to provide long-term efficacy in pediatric patients with UC or CD.

What other types of research exist?

Promising novel alternatives to Mirikizumab for IBD patients include: 1) Adalimumab (Humira) - a TNF-alpha inhibitor with proven efficacy in Crohn's disease and ulcerative colitis. 2) Infliximab (Remicade) - another TNF-alpha inhibitor effective in inducing and maintaining remission in IBD. 3) Certolizumab pegol (Cimzia) - a TNF inhibitor used as a second- or third-line treatment. 4) Tofacitinib (Xeljanz) - an oral Janus kinase inhibitor effective in ulcerative colitis. 5) Ustekinumab (Stelara) - an IL-12/23 inhibitor used for both Crohn's disease and ulcerative colitis. These alternatives offer different mechanisms of action and administration routes, providing various options for personalized treatment plans.

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Monoclonal Antibodies

Mirikizumab for Ulcerative Colitis (SHINE-ON Trial)

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

Be younger than 65 years old

Must not have

Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.

Participants must not have adenomatous polyps that have not been removed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called mirikizumab to see if it can help children with ulcerative colitis or Crohn's disease by reducing inflammation in their digestive tracts.

Who is the study for?

This trial is for pediatric patients who have ulcerative colitis or Crohn's disease and were part of previous mirikizumab studies. They should have completed the last study without serious side effects and could benefit from continued treatment. Girls must agree to use birth control, and participants can't join if they've had severe reactions before, stopped the drug due to risks, have unstable illnesses, untreated polyps, or are pregnant/breastfeeding.

What is being tested?

The trial tests the long-term effectiveness of a medication called mirikizumab in young patients with two types of inflammatory bowel diseases: ulcerative colitis and Crohn's disease. It spans roughly 172 weeks with up to 44 clinic visits to monitor how well the drug works over time.

What are the potential side effects?

While not explicitly listed here, common side effects for drugs like mirikizumab may include injection site reactions, increased risk of infection, headaches, fatigue, abdominal pain, and potential allergic responses.

Eligibility Criteria

Exclusion Criteria

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

Select...

I have never stopped taking the study drug in a way that restarting it would be unsafe.

Select...

I do not have any unremoved adenomatous polyps.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 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 with CD in Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission

Percentage of Participants with UC in Modified Mayo Score (MMS) Clinical Remission

Secondary study objectives

Percentage of Participants with CD Achieving Histologic Response

Percentage of Participants with CD in Corticosteroid-free Remission Without Surgery

Percentage of Participants with CD in Endoscopic Remission

+10 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

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

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

250 mg Miri Q4W Responders to 125 mg Miri Q8W

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

7Treatment groups

Experimental Treatment

Group I: Mirikizumab Dose 7 for UC or CDExperimental Treatment1 Intervention

Intravenous (IV) rescue dosing, if response is lost.

Group II: Mirikizumab Dose 6 for CDExperimental Treatment1 Intervention

Dose 6 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Group III: Mirikizumab Dose 5 for CDExperimental Treatment1 Intervention

Dose 5 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Group IV: Mirikizumab Dose 4 for CDExperimental Treatment1 Intervention

Dose 4 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Group V: Mirikizumab Dose 3 for UCExperimental Treatment1 Intervention

Dose 3 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Group VI: Mirikizumab Dose 2 for UCExperimental Treatment1 Intervention

Dose 2 of Mirikizumab is administered SC Dosing is based on the participant's weight.

Group VII: Mirikizumab Dose 1 for UCExperimental Treatment1 Intervention

Dose 1 of Mirikizumab is administered subcutaneously (SC) Dosing is based on the participant's weight.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirikizumab

2020

Completed Phase 3

~6070

0 / 2Eligibility 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 Inflammatory Bowel Disease (IBD) include biological agents and traditional therapies. Mirikizumab, an IL-23 inhibitor, works by targeting and inhibiting the interleukin-23 pathway, which plays a crucial role in the inflammatory process of IBD. TNF inhibitors, such as infliximab and adalimumab, block tumor necrosis factor-alpha, a cytokine involved in systemic inflammation. Integrin inhibitors, like vedolizumab, prevent white blood cells from migrating to the gut, thereby reducing inflammation. Traditional therapies include corticosteroids, which suppress the immune system to reduce inflammation, and immunomodulators like azathioprine, which alter the immune response. These treatments are vital for IBD patients as they help manage symptoms, induce and maintain remission, and improve quality of life by targeting specific pathways involved in the disease's inflammatory process.

Positioning Therapies in the Management of Crohn's Disease.Early or late guided missile in the treatment of Crohn's disease?