Ligelizumab for Peanut Allergy

Recruiting at 115 trial locations

Overseen By Novartis Pharmaceuticals

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Uncontrolled asthma, Mast cell disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 52 weeks

211 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug ligelizumab for peanut allergy?

While there is no direct data on ligelizumab for peanut allergy, similar treatments like etokimab, which targets allergic reactions, have shown promise in desensitizing peanut-allergic individuals. Additionally, anti-IgE treatments like omalizumab have been effective in facilitating peanut oral immunotherapy, suggesting potential for ligelizumab, which also targets IgE. ^{1 2 3 4 5}

How is the drug ligelizumab different from other treatments for peanut allergy?

Ligelizumab is a next-generation anti-IgE monoclonal antibody that binds with much higher affinity to IgE compared to other treatments like omalizumab, making it potentially more effective in blocking allergic reactions. Unlike traditional treatments that focus on avoiding allergens or managing symptoms, ligelizumab aims to modify the disease by targeting the underlying immune response. ^{1 6 7 8 9}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

Participants must weigh ≥ 20 kg at Screening 1.

A positive peanut DBPCFC at baseline (Screening Visit 2, Part 1 and Part 2 DBPCFC) defined as the occurrence of dose-limiting symptoms at a single dose ≤ 100 mg of peanut protein. Eligibility to proceed with the DBPCFC requires fulfillment of all other eligibility criteria.

You are at least 6 years old and less than 55 years old.

Exclusion Criteria

Total IgE >2000 IU/mL at Screening 1.

Participants with uncontrolled asthma (according to GINA guidelines, GINA 2020) who meet any of the following criteria: FEV1 <80% of subject's predicted normal value at Screening visit 1, One hospitalization for asthma within 12 months prior to Screening visit 1.

There may be additional requirements to participate in the study that will be explained to you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ligelizumab or placebo subcutaneous injections

52 weeks

Every 4 weeks

Interim Analysis

Interim analysis on Pharmacokinetics and selected Pharmacodynamics data

Conducted after Week 12 assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• ligelizumab
• Placebo

Trial Overview 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.

Participant Groups

Group I: ligelizumab 240 mg Experimental Treatment 1 Intervention

ligelizumab 240 mg subcutaneous injection for 52 weeks

Group II: ligelizumab 120 mg Experimental Treatment 1 Intervention

ligelizumab 120 mg subcutaneous injection for 52 weeks

Group III: Placebo 8 weeks and ligelizumab 240 mg Experimental Treatment 2 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 mg Experimental Treatment 2 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 mg Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Findings from Research

In a phase 1 trial involving 15 participants (5 healthy adults and 10 peanut-allergic adults), the rectal administration of the modified peanut protein vaccine EMP-123 showed no significant adverse effects in healthy volunteers, but 50% of peanut-allergic subjects experienced adverse reactions, including severe allergic reactions in 20%.

Despite the adverse reactions, the treatment led to significant reductions in peanut skin test responses and basophil activation, indicating some immunologic effects, although no significant changes were observed in total IgE or peanut-specific IgE levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy. Wood, RA., Sicherer, SH., Burks, AW., et al.[2021]

Food allergies, particularly IgE-mediated reactions, affect a significant portion of the population, with current treatments primarily focusing on allergen avoidance and symptom management, highlighting the need for more effective therapies.

Ligelizumab, a next-generation anti-IgE monoclonal antibody, shows promise in managing food allergies due to its high potency in blocking IgE signaling and a favorable safety profile, warranting further clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale for development of ligelizumab in food allergy. Wood, RA., Chinthrajah, RS., Eggel, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Risk factors associated with safety of preschool peanut oral immunotherapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy. [2020]

3. England pubmed.ncbi.nlm.nih.gov

A pilot study towards the immunological effects of omalizumab treatment used to facilitate oral immunotherapy in peanut-allergic adolescents. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Quantitative Assessment of the Safety Benefits Associated with Increasing Clinical Peanut Thresholds Through Immunotherapy. [2019]

6. Denmark pubmed.ncbi.nlm.nih.gov

A phase 1 study of heat/phenol-killed, E. coli-encapsulated, recombinant modified peanut proteins Ara h 1, Ara h 2, and Ara h 3 (EMP-123) for the treatment of peanut allergy. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Peanut oral immunotherapy modifies IgE and IgG4 responses to major peanut allergens. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Long-Term Outcome of Peanut Oral Immunotherapy Facilitated Initially by Omalizumab. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The rationale for development of ligelizumab in food allergy. [2022]