Remibrutinib for Peanut Allergy

Recruiting at51 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment to see if it can help adults with peanut allergies tolerate peanuts better. People involved in the study will take the treatment for a short period and then try eating increasing amounts of peanut protein to see if their allergic reactions are reduced. The goal is to find out if the treatment can make it safer for people with peanut allergies to eat peanuts.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot use anticoagulants or anti-platelets, except for aspirin or clopidogrel, which may be permitted.

What data supports the idea that Remibrutinib for Peanut Allergy is an effective drug?

The available research does not provide specific data on Remibrutinib for Peanut Allergy. Instead, it discusses another drug, acalabrutinib, which is also a Bruton's tyrosine kinase inhibitor. In a study, patients with peanut allergies who took acalabrutinib were able to tolerate much higher amounts of peanut protein, increasing from a median of 29 mg to 4,044 mg. This suggests that drugs targeting Bruton's tyrosine kinase could be effective for peanut allergies, but specific data on Remibrutinib is not available. ^{1 2 3 4 5}

What safety data is available for Remibrutinib in treating peanut allergy?

The provided research does not mention Remibrutinib or its other names (LOU064, Placebo, Control, Dummy Treatment) in the context of peanut allergy. However, it discusses the safety of acalabrutinib, another BTK inhibitor, in a phase II trial for preventing peanut allergy reactions. In this study, 3 out of 10 patients experienced 4 adverse events possibly related to acalabrutinib, all of which were transient and nonserious. This suggests a need for further research on BTK inhibitors for peanut allergy, but specific safety data for Remibrutinib is not available in the provided documents. ^{1 2 3 5 6}

Is the drug Remibrutinib a promising treatment for peanut allergy?

The information provided does not mention Remibrutinib specifically, but it discusses a similar drug, acalabrutinib, which is a Bruton's tyrosine kinase (BTK) inhibitor. Acalabrutinib showed promising results in increasing the tolerance to peanuts in people with peanut allergies. This suggests that BTK inhibitors like Remibrutinib could potentially be promising treatments for peanut allergies. ^{1 2 3 5 6}

Research Team

Eligibility Criteria

Adults with a confirmed peanut allergy can join this trial. They must have had a positive skin test, specific blood test results, and reacted to peanuts in an oral challenge. Participants should be able to follow the study plan and avoid other allergens but cannot join if they have uncontrolled asthma, bleeding risks, or are on certain blood thinners.

Inclusion Criteria

Positive peanut IgE >=6kUA/L

Willingness to comply with study schedule and procedures and avoid other allergens during study period

Positive Oral Food Challenge to peanut during screening for study

Exclusion Criteria

There may be additional requirements or restrictions for participating in the study that are specific to the study protocol.

You have had a very serious allergic reaction that required you to be admitted to the intensive care unit or be put on a breathing machine within the past two months.

My asthma is not well-managed with current treatments.

Treatment Details

Interventions

• Placebo (Other)
• Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)

Trial Overview The trial is testing remibrutinib at three different doses compared to a placebo in adults allergic to peanuts. The main goal is to see if participants can handle more peanut protein after taking the treatment for one month without having an allergic reaction.

Participant Groups

Group I: remibrutinib medium dose Experimental Treatment 1 Intervention

remibrutinib oral tablet

Group II: remibrutinib low dose Experimental Treatment 1 Intervention

remibrutinib oral tablet

Group III: remibrutinib high dose Experimental Treatment 1 Intervention

remibrutinib oral tablet

Group IV: placebo 3 week / remibrutinib low dose 1 week Experimental Treatment 2 Interventions

placebo oral tablet/ remibrutinib oral tablet

Group V: placebo Placebo Group 1 Intervention

oral tablet

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 trial involving 10 adults with peanut allergies, the BTK inhibitor acalabrutinib significantly increased the median tolerated dose of peanut protein from 29 mg to 4,044 mg, demonstrating its potential efficacy in preventing allergic reactions.

The treatment was generally safe, with only 4 transient and nonserious adverse events reported, indicating that acalabrutinib could be a promising option for managing peanut allergies, warranting further larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase II study of Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis. Suresh, RV., Dunnam, C., Vaidya, D., et al.[2023]

In an open-label trial involving adults with IgE-mediated peanut allergy, acalabrutinib, a BTK inhibitor, significantly increased the median tolerated dose of peanut protein from 29 mg to 4,044 mg, demonstrating its potential efficacy in preventing allergic reactions.

The treatment was generally safe, with only four transient and nonserious adverse events reported among the ten participants, suggesting that acalabrutinib could be a promising option for enhancing food allergen tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis: an open-label, phase 2 trial. Suresh, RV., Dunnam, C., Vaidya, D., et al.[2023]

ASP0892, a peanut DNA vaccine, was found to be well tolerated in both adults and adolescents with peanut allergy, with the most common side effect being mild injection site itching, and no serious adverse events reported.

While ASP0892 did lead to modest increases in specific immune responses (IgG and IgG4), it did not result in significant clinical improvements in peanut allergy symptoms during food challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunopharmacology of ASP0892 in adults or adolescents with peanut allergy: two randomized trials. Ferslew, BC., Smulders, R., Zhu, T., et al.[2023]

Peanut allergy is increasingly common in children, particularly in developed countries, and while the exact reasons for this rise are unclear, it is a significant health concern that requires careful management.

Recent trials of peanut oral immunotherapy (OIT) have shown promise in desensitizing individuals to peanuts, offering a potential treatment option, although there is currently no cure for peanut allergy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut allergy. Pansare, M., Kamat, D.[2015]

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]

The covalent heterobivalent inhibitor (cHBI) effectively prevented peanut allergy reactions in a humanized mouse model for over 2 weeks after administration before allergen exposure, demonstrating its potential as a preventive therapy.

cHBI not only prevented severe allergic reactions but also reduced symptoms and prevented fatal anaphylaxis when given shortly after symptoms began, indicating its efficacy in managing peanut-induced allergies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peanut allergen inhibition prevents anaphylaxis in a humanized mouse model. Alakhras, NS., Shin, J., Smith, SA., et al.[2023]

References

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

A phase II study of Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis. [2023]

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

Bruton's tyrosine kinase inhibition for the prevention of anaphylaxis: an open-label, phase 2 trial. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

Safety and immunopharmacology of ASP0892 in adults or adolescents with peanut allergy: two randomized trials. [2023]

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

Peanut allergy. [2015]

5. 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]

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

Peanut allergen inhibition prevents anaphylaxis in a humanized mouse model. [2023]