What side effects are associated with this type of intervention?

Common treatments for peanut allergy include peanut epicutaneous immunotherapy (EPIT) and sublingual immunotherapy (SLIT). EPIT often results in local skin reactions, such as itching and redness, but serious adverse events are rare. SLIT can cause mild adverse events like itching in the mouth, eyes, or throat, and rhinitis, with some participants experiencing more severe reactions like blisters in the mouth. For treatments similar to Remibrutinib, which is a BTKi, side effects can include reduced or eliminated skin prick test responses to allergens, and in some cases, protection against severe anaphylaxis.

What prior FDA approvals exist?

Currently, there are no FDA-approved Bruton's Tyrosine Kinase Inhibitors (BTKis) specifically for the treatment of peanut allergy. However, BTKis like acalabrutinib and ibrutinib have shown potential in reducing allergic responses in clinical trials. The primary FDA-approved treatment for peanut allergy is Palforzia, an oral immunotherapy that helps desensitize patients to peanut protein. Other investigational treatments include sublingual immunotherapy and monoclonal antibodies targeting allergic pathways.

What other types of research exist?

Promising novel alternatives to Remibrutinib for peanut allergy patients in 2024 include monoclonal antibodies and sublingual immunotherapy. Monoclonal antibodies, such as anti-IgE therapies, have shown potential in managing severe allergies. Additionally, sublingual immunotherapy (SLIT) has been explored for various allergens and could be a viable option for peanut allergies, offering a non-invasive treatment approach.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Remibrutinib for Peanut Allergy

Phase 2

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Uncontrolled asthma

Bleeding risk or coagulation disorder(s)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, days 26 and 28

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of drugs like remibrutinib may include headaches, stomach issues, fatigue or dizziness. Since it's being tested for allergies, there might also be potential allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My asthma is not well-managed with current treatments.

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I have a bleeding risk or a disorder that affects my blood's ability to clot.

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I do not have any major health issues that could make the trial unsafe for me.

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I have had my spleen removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, days 26 and 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, days 26 and 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, days 26 and 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=600mg of peanut protein without dose-limiting symptoms during DBPCFC

Secondary study objectives

AUClast of remibrutinib

AUCtau of remibrutinib

Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test

+7 more

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: remibrutinib medium doseExperimental Treatment1 Intervention

remibrutinib oral tablet

Group II: remibrutinib low doseExperimental Treatment1 Intervention

remibrutinib oral tablet

Group III: remibrutinib high doseExperimental Treatment1 Intervention

remibrutinib oral tablet

Group IV: placebo 3 week / remibrutinib low dose 1 weekExperimental Treatment2 Interventions

placebo oral tablet/ remibrutinib oral tablet

Group V: placeboPlacebo Group1 Intervention

oral tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

placebo

2010

Completed Phase 4

~6580

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for peanut allergy include immunotherapy and targeted biologic therapies. Immunotherapy, such as oral or sublingual immunotherapy, works by gradually desensitizing the immune system to peanut allergens, reducing the severity of allergic reactions. Bruton's Tyrosine Kinase (BTK) inhibitors, like Remibrutinib, function by blocking BTK, a key enzyme in the signaling pathways of immune cells, thereby preventing the activation and release of inflammatory mediators that cause allergic reactions. This is crucial for peanut allergy patients as it can potentially reduce the risk of severe allergic reactions and improve their quality of life by providing a more targeted and effective treatment option.

The Use of Bruton's Tyrosine Kinase Inhibitors to Treat Allergic Disorders.Phase 2a randomized, placebo-controlled study of anti-IL-33 in peanut allergy.Specific allergen immunotherapy for the treatment of atopic eczema: a Cochrane systematic review.