Long-term Ligelizumab for Food Allergy

Recruiting at 85 trial locations

Overseen By Novartis Pharmaceuticals

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Severe allergic reaction, Uncontrolled asthma, Cardiovascular conditions, 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: 156 weeks

163 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 study team or your doctor.

What data supports the effectiveness of the drug Ligelizumab for food allergy?

Ligelizumab is a promising drug for food allergies because it binds to IgE (a type of antibody involved in allergic reactions) with much higher affinity than omalizumab, another anti-IgE drug that has shown success in treating allergies. This means Ligelizumab could potentially block allergic reactions more effectively, as seen in studies for asthma and other allergies. ^{1 2 3 4 5}

Is ligelizumab safe for use in humans?

Ligelizumab has shown a good safety profile in studies for chronic spontaneous urticaria, a condition unrelated to food allergies, suggesting it is generally safe for human use. ^{2 3 6 7 8}

How is the drug ligelizumab different from other treatments for food allergies?

Ligelizumab is unique because it is a next-generation anti-IgE antibody that binds to IgE with much higher affinity than existing treatments like omalizumab, making it potentially more effective in blocking allergic reactions. This drug targets a different part of the IgE molecule, which may lead to better suppression of allergic responses in food allergies. ^{1 2 3 6 9}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

Signed informed consent and assent form (where applicable)

Participants have completed the treatment period in any ligelizumab Phase III studies in food allergy

I am willing to follow the study's schedule, get injections, and do the food challenge.

Exclusion Criteria

I experienced a severe side effect suspected to be caused by the study treatment.

My asthma got worse during the study and could be unsafe for me.

Development of clinically significant cardiovascular, neurological, and or psychiatric conditions during the core study that could interfere with or compromise the safety of the participants, interfere with evaluation or interpretation of the study results or preclude completion of the study judged by the investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ligelizumab treatment every 4 weeks, with administration either in the hospital clinic or at home, for up to 3 years

156 weeks

Every 4 weeks (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Treatment Details

Interventions

• Ligelizumab

Trial Overview 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.

Participant Groups

Group I: Ligelizumab 240 mg Experimental Treatment 1 Intervention

240 mg

Group II: Ligelizumab 120 mg Experimental Treatment 1 Intervention

120 mg

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

Oral immunotherapy is the most established treatment for immunoglobulin E-mediated food allergies, providing desensitization but requiring ongoing maintenance and often leading to adverse effects.

Novel adjunct therapies, such as omalizumab and Bruton's tyrosine kinase inhibitors, are being explored to enhance the safety and effectiveness of food allergy treatments, potentially allowing for targeting multiple allergies and improving treatment durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jak out of the box: Targeting Bruton's tyrosine kinase, sialic acid-binding immunoglobulin-like lectin-8, and Janus kinase 1 in food allergy. Berin, C.[2023]

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]

Ligelizumab 240 mg was well-tolerated in a long-term study with 226 patients, showing no new safety concerns, and most adverse events were mild or moderate and unrelated to the treatment.

After 52 weeks of treatment, 75.8% of patients achieved complete responses, indicating ligelizumab's effectiveness in managing chronic spontaneous urticaria symptoms over an extended period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. Maurer, M., Giménez-Arnau, A., Bernstein, JA., et al.[2022]

In a phase 2b trial involving 382 patients with chronic spontaneous urticaria, ligelizumab at doses of 72 mg and 240 mg resulted in a higher percentage of patients achieving complete control of hives (51% and 42%, respectively) compared to omalizumab (26%) and placebo (0%).

The study established a dose-response relationship for ligelizumab, indicating that higher doses lead to better symptom control, and no safety concerns were reported for either ligelizumab or omalizumab during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ligelizumab for Chronic Spontaneous Urticaria. Maurer, M., Giménez-Arnau, AM., Sussman, G., et al.[2021]

Omalizumab, a monoclonal antibody that targets immunoglobulin E, shows promise as a safe and effective monotherapy for desensitizing patients with severe food allergies, based on early-stage clinical trial data.

This treatment may allow for desensitization to one or more food allergens without the need for direct allergen exposure, paving the way for personalized therapies tailored to individual patient profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab as monotherapy for food allergy. Arasi, S., Mennini, M., Cafarotti, A., et al.[2023]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Ligelizumab treatment for severe asthma: learnings from the clinical development programme. [2022]

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

Jak out of the box: Targeting Bruton's tyrosine kinase, sialic acid-binding immunoglobulin-like lectin-8, and Janus kinase 1 in food allergy. [2023]

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

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

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

State of the art on food allergen immunotherapy: oral, sublingual, and epicutaneous. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Monoclonal Antibodies in Treating Food Allergy: A New Therapeutic Horizon. [2021]

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

Sustained safety and efficacy of ligelizumab in patients with chronic spontaneous urticaria: A one-year extension study. [2022]

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

Ligelizumab for Chronic Spontaneous Urticaria. [2021]

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

Omalizumab as monotherapy for food allergy. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

Ligelizumab impairs IgE-binding to plasmacytoid dendritic cells more potently than omalizumab and restores IFN-&#945; production and FOXP3+ Treg generation. [2023]