What side effects are associated with this type of intervention?

Common treatments for food allergies involving monoclonal antibodies targeting IgE, such as omalizumab and talizumab, have shown potential in increasing the threshold for allergic reactions. However, these treatments are associated with several side effects. Patients may experience mild to severe allergic reactions, including anaphylaxis, particularly during initial food challenges. Other side effects can include injection site reactions, headaches, and gastrointestinal issues. There is also a risk of developing eosinophilic esophagitis. Long-term monotherapy can be costly, and more studies are needed to fully understand the safety and efficacy of these treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for food allergies, particularly focusing on oral immunotherapy (OIT) for peanut allergies. One notable example is AR101 (Palforzia), which is an oral immunotherapy for peanut allergy. While there are ongoing studies on monoclonal antibodies targeting IgE, such as ligelizumab, omalizumab (Xolair) is an FDA-approved monoclonal antibody that targets IgE and is used to treat moderate to severe persistent asthma and chronic idiopathic urticaria, but it is also being explored for its potential in food allergy treatment. These treatments aim to desensitize patients to allergens and reduce the severity of allergic reactions.

What other types of research exist?

Promising novel alternatives to Ligelizumab for food allergy patients include Omalizumab, which has shown efficacy in managing food allergies and other allergic conditions. Additionally, emerging therapies such as bispecific antibodies (e.g., ABT-122, COVA322) and other monoclonal antibodies targeting B-cells (e.g., ocrelizumab, veltuzumab) are being explored for their potential in treating immune-mediated inflammatory diseases, which may extend to food allergies.

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Long-term Ligelizumab for Food Allergy

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing the long-term safety and effectiveness of ligelizumab, a medication for food allergies. Ligelizumab is a new type of medication that has shown promise in treating certain allergic conditions and is now being tested for food allergies. It works by blocking proteins that trigger allergic reactions, helping to prevent symptoms. It is being tested on people who have already participated in an earlier study of this medication.

Who is the study for?

This trial is for individuals who have completed a Phase III study of ligelizumab for food allergies. They must be willing to follow the study's schedule, avoid allergens, and participate in oral food challenges. People with severe allergic reactions during previous studies, uncontrolled asthma, or significant health issues that could affect safety are not eligible.

What is being tested?

The trial is testing long-term effects of two doses of ligelizumab (120 mg and 240 mg) on people with food allergies. It aims to understand the ongoing safety and effectiveness after initial positive results from earlier trials.

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any long-term adverse reactions related to ligelizumab since this extension study focuses on its continued safety and efficacy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 10 days before and 3 days after week 52, 10 days before and 3 days after week 104, 10 days before and 3 days after week 156 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 treatment-emergent AEs and SAEs

Secondary study objectives

Number of participants tolerating a single dose of more than or equal to 600 mg of peanut protein without dose-limiting symptoms

Number of treatment emergent AEs and SAEs

Scores in the Food Allergy Independent Measure (FAIM) by age and responder

+2 more

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

2Treatment groups

Experimental Treatment

Group I: Ligelizumab 240 mgExperimental Treatment1 Intervention

240 mg

Group II: Ligelizumab 120 mgExperimental Treatment1 Intervention

120 mg

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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

Monoclonal antibodies like Ligelizumab work by targeting and neutralizing IgE, the antibody responsible for allergic reactions, thereby preventing the cascade of immune responses that lead to symptoms. This is crucial for food allergy patients as it can significantly reduce the risk of severe allergic reactions. Other treatments include oral immunotherapy (OIT), which involves the gradual introduction of small amounts of the allergen to build tolerance, and the use of probiotics or immunostimulatory adjuvants to enhance the effectiveness of OIT. These treatments aim to desensitize the immune system, reduce allergic responses, and improve the quality of life for food allergy patients.