What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease, such as ustekinumab and anti-TNF therapies (infliximab, adalimumab, and certolizumab pegol), have several known side effects. Ustekinumab can cause infections and nasopharyngitis. Anti-TNF therapies may lead to serious infections, including tuberculosis, and other adverse effects like injection site reactions, liver enzyme abnormalities, and increased risk of certain cancers. Patients on these treatments should be closely monitored for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several biologic agents for the treatment of Crohn's Disease, focusing on monoclonal antibodies that target specific components of the immune system to reduce inflammation. Anti-TNF agents such as infliximab, adalimumab, and certolizumab pegol are commonly used and have shown efficacy in inducing and maintaining remission. Vedolizumab, an integrin inhibitor, targets the alpha-4-beta-7 integrin to prevent immune cells from migrating to the gut, and ustekinumab, an interleukin inhibitor, targets IL-12 and IL-23 to reduce inflammation. These treatments are similar to Ontamalimab, which targets MAdCAM-1 to reduce inflammation in Crohn's Disease.

What other types of research exist?

Promising novel alternatives to Ontamalimab for Crohn's Disease patients include: 1) Risankizumab, a monoclonal antibody targeting the IL-23 p19 subunit, which has shown clinical and endoscopic remission in phase II studies. 2) Certolizumab pegol, a pegylated humanized Fab' fragment with high binding affinity for TNF-alpha, effective as maintenance therapy. 3) Natalizumab, a selective adhesion molecule inhibitor, which has shown promising results in reducing relapse rates in Crohn's Disease.

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Monoclonal Antibodies

Ontamalimab for Ulcerative Colitis

Phase 3

Waitlist Available

Research Sponsored by Shire

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a medication called ontamalimab to see if it is safe and can be tolerated over an extended period. It targets people with moderate to severe Ulcerative Colitis or Crohn's disease, conditions that cause chronic inflammation in the gut. The medication works by calming the immune system to reduce this inflammation.

Who is the study for?

This trial is for people with moderate to severe Ulcerative Colitis or Crohn's Disease who have previously responded well to Ontamalimab treatment in earlier studies. They must understand and agree to the study rules, be on a stable dose of current treatments, and not plan any major surgeries. Pregnant women, those planning pregnancy, or individuals unable to follow contraception guidelines cannot participate.

What is being tested?

The AIDA trial is testing the long-term safety and tolerability of two doses (25 mg and 75 mg) of Ontamalimab in patients with Ulcerative Colitis or Crohn's Disease who've had positive responses in prior related trials.

What are the potential side effects?

While specific side effects are not listed here, typical ones may include reactions at the injection site, gastrointestinal symptoms like nausea or diarrhea, potential infections due to immune system suppression by Ontamalimab, headaches, fatigue, and possible allergic reactions.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With Discernible Changes in Electrocardiogram (ECG) Over Time

Number of Participants With Discernible Changes in Vital Signs Over Time

Number of Participants With Notable Changes in Clinical Laboratory Parameters Over Time

+2 more

Secondary study objectives

Number of Participants With Crohn's Disease With Treatment Response Over Time

Number of Participants With Ulcerative Colitis With Treatment Response Over Time

Side effects data

From 2023 Phase 3 trial • 557 Patients • NCT03283085

15%

Corona virus infection

12%

Anal fistula

12%

Crohn's disease

12%

Headache

12%

Nasopharyngitis

Diverticulitis

Abdominal pain

Leukopenia

Uterine leiomyoma

Enterocolitis

Proctitis

Anaemia

Anal abscess

Arthralgia

Back pain

Dental caries

Diarrhoea

Dyspepsia

Gastroenteritis

Irritable bowel syndrome

Pain in extremity

Pyrexia

Sinusitis

Upper respiratory tract infection

100%

80%

60%

40%

20%

Study treatment Arm

CD: Ontamalimab 75 mg

CD: Ontamalimab 25 mg Then 75 mg

UC: Ontamalimab 25 mg

UC: Ontamalimab 25mg Then 75 mg

UC: Ontamalimab 75mg

CD: Ontamalimab 25 mg

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Ulcerative Colitis (UC): Ontamalimab 25 mgExperimental Treatment1 Intervention

Participants received 25 milligrams (mg) of ontamalimab solution for injection subcutaneously (SC), every 4 weeks (Q4W), for up to 3 years.

Group II: UC: Ontamalimab 75 mgExperimental Treatment1 Intervention

Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

Group III: UC: Ontamalimab 25mg then 75 mgExperimental Treatment2 Interventions

Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

Group IV: Crohn's disease (CD): Ontamalimab 25 mgExperimental Treatment1 Intervention

Participants received 25 mg of ontamalimab solution for injection SC, Q4W, for up to 3 years.

Group V: CD: Ontamalimab 75 mgExperimental Treatment1 Intervention

Participants received 75 mg of ontamalimab solution for injection SC, Q4W, for up to 5.79 years.

Group VI: CD: Ontamalimab 25mg then 75 mgExperimental Treatment2 Interventions

Participants received 25 mg of ontamalimab solution for injection SC, Q4W, and later progressed to receive 75 mg in a similar manner for up to 5.79 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

25 mg Ontamalimab

2018

Completed Phase 3

~560

75 mg Ontamalimab

2018

Completed Phase 3

~560

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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

Common treatments for Crohn's Disease often involve monoclonal antibodies that target specific components of the immune system to reduce inflammation. For example, infliximab and adalimumab are anti-TNF (tumor necrosis factor) agents that neutralize TNF-alpha, a cytokine involved in systemic inflammation. Certolizumab pegol also targets TNF-alpha but has a modified structure to increase its half-life. Ontamalimab, the focus of the referenced study, targets MAdCAM-1, a molecule involved in the recruitment of inflammatory cells to the gut. By blocking these pathways, these treatments help to reduce the chronic inflammation characteristic of Crohn's Disease, thereby alleviating symptoms and potentially inducing remission. This is crucial for patients as it can improve quality of life and reduce the risk of complications associated with ongoing inflammation.

Review article: biological agents in the treatment of Crohn's disease.