Ligelizumab for Peanut Allergy

No longer recruiting at 119 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new drug, ligelizumab, for individuals with peanut allergies. Participants will receive injections of either the drug or a placebo (a harmless substance) to assess their tolerance to peanuts over time. The trial seeks individuals medically diagnosed with a peanut allergy who have experienced allergic reactions to peanuts. Those with a known peanut allergy and reactions to even small amounts may find this trial suitable. 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 peanut 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.

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

Research shows that ligelizumab is generally safe for people. In earlier studies, participants with peanut allergies who took ligelizumab did not encounter new safety issues. The safety results matched those in previous research, indicating consistency and reliability.

Studies report that ligelizumab did not cause unexpected side effects. The most common reactions were mild, such as redness or swelling at the injection site. Serious side effects were rare and similar to those seen with other allergy treatments.

Overall, these findings suggest ligelizumab is safe for people with peanut allergies, based on the data collected so far. Always consult healthcare professionals to understand any potential risks specific to your situation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ligelizumab for peanut allergy because it targets a specific part of the immune system called IgE antibodies, which play a crucial role in allergic reactions. Unlike the standard of care, which often involves oral immunotherapy that gradually increases peanut exposure, ligelizumab is administered as a subcutaneous injection. This could potentially offer a more targeted and convenient treatment option for patients. Additionally, ligelizumab might provide faster relief from allergic symptoms and reduce the risk of severe reactions, making it a promising alternative to current therapies.

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

Research has shown that ligelizumab may help treat peanut allergies. One study found that participants taking ligelizumab tolerated significantly more peanut exposure—16 times more, on average—compared to those taking a placebo (a harmless pill with no active medicine). This trial will evaluate different dosing regimens of ligelizumab, including some arms where participants initially receive a placebo before transitioning to ligelizumab. These findings suggest that ligelizumab could be an effective treatment option for those with peanut allergies. ^{1 2 3 6 7}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04984876

Study Details | NCT04984876 | Efficacy and Safety of ... This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing ...

2. 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 ...

3. 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 ...

4. clinicaltrial.be clinicaltrial.be/en/details/268502?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Long-term Extension Study of Ligelizumab in Food Allergy... Scores range from 1 (limited) to 7 (greatest) perceived food allergy severity and food allergy related risk.

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/76/NCT04984876/Prot_000.pdf

controlled study to assess the clinical efficacy and safety of Efficacy and safety of QGE031 (ligelizumab) in patients with peanut allergy ... Recent mechanistic data has shown that ligelizumab is very effective at ...

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

Articles Efficacy and safety of ligelizumab in adults and ... Ligelizumab was well tolerated with no new safety signals, and the overall safety profile was consistent with that observed in the phase 2b core ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4278557/

Pharmacokinetics, pharmacodynamics and safety of ... A cohort size of 40 subjects on active drug provided 80% confidence that the incidence of hypersensitivity events after subcutaneous administration of 2 mg/kg ...