What is the mechanism of action of this treatment?

Common treatments for peanut allergy include oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT), and monoclonal antibodies like Ligelizumab. Ligelizumab works by targeting and neutralizing IgE antibodies, which play a crucial role in allergic reactions. By reducing IgE levels, Ligelizumab can decrease the severity of allergic responses. This is significant for peanut allergy patients as it can potentially reduce the risk of severe allergic reactions, improve quality of life, and increase the threshold of peanut exposure that can be tolerated without adverse effects.

What side effects are associated with this type of intervention?

Common treatments for peanut allergy, including anti-IgE monoclonal antibodies like Ligelizumab, oral immunotherapy (OIT), and epicutaneous immunotherapy (EPIT), have various side effects. Anti-IgE treatments are generally well-tolerated but can cause injection site reactions and, rarely, anaphylaxis. OIT often leads to gastrointestinal symptoms, such as abdominal pain and vomiting, and can increase the risk of severe allergic reactions, including anaphylaxis. EPIT primarily causes local skin reactions, such as erythema and pruritus, and less frequently, systemic allergic reactions. Overall, while these treatments can be effective, they carry a risk of adverse events that should be carefully managed.

What prior FDA approvals exist?

As of now, the FDA has approved Palforzia, an oral immunotherapy (OIT) for peanut allergy, which involves the gradual introduction of peanut protein to desensitize patients. While Palforzia is not an anti-IgE monoclonal antibody like Ligelizumab, it represents a significant advancement in peanut allergy treatment. Anti-IgE therapies, such as omalizumab (Xolair), have been studied in combination with OIT to improve safety and efficacy, but omalizumab itself is not specifically approved for peanut allergy.

What other types of research exist?

Promising novel alternatives to Ligelizumab for peanut allergy treatment include: 1) ASP0892 (ARA-LAMP-vax), a DNA plasmid vaccine targeting multiple peanut proteins, which has shown safety, tolerability, and immune response in clinical trials. 2) Oral immunotherapy (OIT) approaches, which have demonstrated increased regulatory T-cell function and potential for sustained unresponsiveness in peanut-allergic patients. 3) Engineered recombinant peanut proteins co-administered with heat-killed Listeria monocytogenes, which have shown protection against peanut-induced anaphylaxis in preclinical models.

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Monoclonal Antibodies

Ligelizumab for Peanut 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 baseline, week 12 part 1 (10 days before day 1 oral food challenge (ofc)), week 12 part 2 (3 days after day 2 oral food challenge (ofc))

Awards & highlights

Pivotal Trial

Summary

This trial tests the safety and effectiveness of ligelizumab injections in people with peanut allergies. The treatment aims to prevent allergic reactions by blocking the immune response to peanuts. Participants will receive either a high dose or a low dose of the treatment. Ligelizumab is a next-generation treatment in development for allergies.

Who is the study for?

This trial is for individuals aged 6-55 with a medically confirmed diagnosis of IgE-mediated peanut allergy. They must weigh at least 20 kg, have positive tests for peanut-specific antibodies and skin reactions to peanuts, and experience symptoms from ≤100 mg of peanut protein. It's not for those with uncontrolled asthma or recent severe allergic events.

What is being tested?

The study is testing the safety and effectiveness of Ligelizumab (240 mg and 120 mg) given as an injection every four weeks compared to a placebo in reducing allergic reactions to peanuts over a period of one year.

What are the potential side effects?

Potential side effects are not detailed here but may include typical drug-related reactions such as pain at the injection site, fatigue, headaches, or allergic responses. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 12 part 1 (10 days before day 1 oral food challenge (ofc)), week 12 part 2 (3 days after day 2 oral food challenge (ofc))

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 12 part 1 (10 days before day 1 oral food challenge (ofc)), week 12 part 2 (3 days after day 2 oral food challenge (ofc))

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 part 1 (10 days before day 1 oral food challenge (ofc)), week 12 part 2 (3 days after day 2 oral food challenge (ofc)) 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 Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms at Week 12

Secondary study objectives

Change From Baseline in Maximum Tolerated Dose (MTD) of Peanut Protein Without Dose-limiting Symptoms During the DBPCFC at Week 12 and Week 52

Change From Baseline in Peanut-specific Immunoglobulin E (IgE) at Week 12 and Week 52

Change From Baseline in Peanut-specific Immunoglobulin G4 (IgG4) at Week 12 and Week 52

+11 more

Awards & Highlights

Pivotal Trial

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: ligelizumab 240 mgExperimental Treatment1 Intervention

ligelizumab 240 mg subcutaneous injection for 52 weeks

Group II: ligelizumab 120 mgExperimental Treatment1 Intervention

ligelizumab 120 mg subcutaneous injection for 52 weeks

Group III: Placebo 8 weeks and ligelizumab 240 mgExperimental Treatment2 Interventions

Placebo subcutaneous injection for first 8 weeks and ligelizumab 240 mg subcutaneous injection for 44 weeks

Group IV: Placebo 8 weeks and ligelizumab 120 mgExperimental Treatment2 Interventions

Placebo subcutaneous injection for first 8 weeks and ligelizumab 120 mg subcutaneous injection for 44 weeks

Group V: Placebo 16 weeks and ligelizumab 120 mg/240 mgExperimental Treatment2 Interventions

Placebo subcutaneous injection for first 16 weeks and ligelizumab 120 mg OR 240 mg subcutaneous injection for 36 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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

Common treatments for peanut allergy include oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT), and monoclonal antibodies like Ligelizumab. Ligelizumab works by targeting and neutralizing IgE antibodies, which play a crucial role in allergic reactions. By reducing IgE levels, Ligelizumab can decrease the severity of allergic responses. This is significant for peanut allergy patients as it can potentially reduce the risk of severe allergic reactions, improve quality of life, and increase the threshold of peanut exposure that can be tolerated without adverse effects.

Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long-term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.Enhancing the Safety and Efficacy of Food Allergy Immunotherapy: a Review of Adjunctive Therapies.