What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, particularly biologics like Mirikizumab (IL-23 inhibitor), Ustekinumab (IL-12/23 inhibitor), and anti-TNF agents (e.g., Infliximab, Adalimumab), have several known side effects. These can include increased risk of infections, nasopharyngitis, and injection site reactions. Anti-TNF agents may also cause infusion reactions, lupus-like syndrome, and increased risk of certain cancers. Ustekinumab is generally well-tolerated but can cause infections and nasopharyngitis. Long-term safety data for Mirikizumab is still being studied, but it is expected to have a similar side effect profile to other IL-23 inhibitors.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Crohn's Disease. Anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol are commonly used. Ustekinumab, an IL-12/23 inhibitor, is another option for patients who have failed other biologics. Vedolizumab, a gut-selective integrin inhibitor, is also approved for moderate to severe cases. These treatments aim to reduce inflammation and induce remission in patients with Crohn's Disease.

What other types of research exist?

Promising novel alternatives to Mirikizumab for Crohn's Disease patients include Ustekinumab (IL-12/23 inhibitor) and Brodalumab (IL-17 inhibitor). Ustekinumab has shown effectiveness in Crohn's Disease, and Brodalumab has been studied for its efficacy in Crohn's Disease, although primarily used for psoriasis.

← Back to Search

Monoclonal Antibodies

Mirikizumab for Crohn's Disease (VIVID-2 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 older than 18 years old

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 previous study

Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing mirikizumab to see if it can help people with Crohn's disease feel better over a long time and ensure it is safe. The drug works by reducing gut inflammation.

Who is the study for?

This trial is for people who have Crohn's disease and completed previous studies (NCT02891226 or NCT03926130). Women must follow contraception rules. People with new risks like cancer, known allergies to mirikizumab, severe reactions in past trials, pregnancy, certain infections like hepatitis or HIV/AIDS can't join.

What is being tested?

The study tests the long-term effects and safety of a drug called Mirikizumab on individuals with Crohn's disease. It aims to see how well it works over an extended period following earlier trials.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions due to long-term use of Mirikizumab as part of assessing its safety profile.

Eligibility Criteria

Exclusion Criteria

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

Select...

I do not have significant infections like hepatitis B/C, HIV/AIDS, or active TB.

Select...

I am not allergic to mirikizumab or similar medications.

Select...

I haven't developed any new conditions that would make joining this trial unsafe.

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 Achieving Clinical Remission

Percentage of Participants Achieving Endoscopic Response

Secondary study objectives

Change from Baseline in C-Reactive Protein

Change from Baseline in Fecal Calprotectin

Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)

+2 more

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 to Placebo Q8W (Responders) Follow-up Period

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

250 mg Miri Q4W Responder to 250 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

2Treatment groups

Experimental Treatment

Group I: Mirikizumab SCExperimental Treatment1 Intervention

Mirikizumab given subcutaneously (SC).

Group II: Mirikizumab IV and SCExperimental Treatment1 Intervention

Mirikizumab given intravenously (IV) and SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirikizumab

2020

Completed Phase 3

~6070

0 / 3Eligibility 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 Crohn's Disease include biologic therapies that target specific components of the immune system to reduce inflammation. Mirikizumab, an IL-23 inhibitor, works by blocking the action of interleukin-23, a cytokine involved in the inflammatory process of Crohn's Disease. This helps to reduce inflammation and maintain remission. Other common treatments include anti-TNF agents like infliximab and adalimumab, which inhibit tumor necrosis factor-alpha (TNF-α), another key cytokine in inflammation, and integrin inhibitors like vedolizumab, which prevent immune cells from migrating to the gut. These treatments are crucial for Crohn's Disease patients as they help manage symptoms, reduce flare-ups, and improve quality of life by targeting the underlying inflammatory pathways.