Long-term Ligelizumab for Food Allergy

No longer recruiting at 94 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the long-term safety and effectiveness of ligelizumab, a treatment for food allergies. Participants will receive either 120 mg or 240 mg of ligelizumab to assess its efficacy over time. The trial seeks individuals who have completed a previous phase of a ligelizumab study for food allergy and are willing to continue avoiding allergens. Participants must commit to attending study visits and procedures, such as injections and food challenges. Those who experienced a severe allergic reaction or had uncontrolled asthma in the previous study may not be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment for food 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 study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ligelizumab is generally safe for treating food allergies. In earlier studies, patients who took a 240 mg dose of ligelizumab for a year experienced no unexpected safety problems. Another study confirmed that ligelizumab's safety profile remained consistent, with no new concerns. Overall, these results suggest that ligelizumab is safe for long-term use, with side effects similar to those observed in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Ligelizumab is unique because it targets a specific part of the immune system, the IgE antibodies, which play a key role in food allergies. Most current treatments for food allergies involve avoiding allergens or using emergency medications like epinephrine for reactions. Ligelizumab stands out by potentially preventing allergic reactions from happening in the first place. Researchers are excited about its ability to provide long-term protection against food allergies, offering a proactive rather than reactive approach. This could significantly improve the quality of life for those affected by food allergies.

What evidence suggests that this trial's treatments could be effective for food allergy?

Research has shown that ligelizumab might help treat food allergies. In past studies, patients reported fewer symptoms, such as hives and swelling, which are common in allergic reactions. Some patients also noticed an improved quality of life related to their food allergies. This trial will test different dosages of ligelizumab, specifically 120 mg and 240 mg, to evaluate its effectiveness in managing food allergy symptoms over time. ^{1 2 3 5 6}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Ligelizumab 240 mg Experimental Treatment 1 Intervention

Participants received ligelizumab 240 mg every 4 weeks.

Group II: Ligelizumab 120 mg Experimental Treatment 1 Intervention

Participants received ligelizumab 120 mg and matching placebo (to protect the dose blinding) every 4 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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9483652/

The rationale for development of ligelizumab in food allergy The efficacy of talizumab 450 mg was statistically significant vs placebo (p < 0.001), with subjects showing an average ∼16-fold increase in their peanut ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04984876

Study Details | NCT04984876 | Efficacy and Safety of ... The questionnaire consists of six questions; The first four questions assess the participant's food allergy expectation outcomes and the remaining two questions ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05678959

Long-term Extension Study of Ligelizumab in Food Allergy Long-term impact of ligelizumab on the health-related qualify of life of patients with food allergy. Scores range from 1 (limited) to 7 (greatest) perceived ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673623016847

Articles Efficacy and safety of ligelizumab in adults and ... In a previously published phase 2b study, ligelizumab demonstrated improvement in the urticaria symptom control, CSU-related angioedema, sleep, ...

5. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/12064/a-three-year-multi-center-double-blind/

A three-year, multi-center, double-blind, extension study to ... Accordingly, this study will generate data that should provide guidance relative to the long-term (chronic) use of ligelizumab in food allergic ...

6. trials.foodallergy.org trials.foodallergy.org/trials/NCT04984876

Efficacy and Safety of QGE031 (Ligelizumab) in Patients With ... This is a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens ...