Remibrutinib for Peanut Allergy

No longer recruiting at 54 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Uncontrolled asthma, Bleeding risk, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 4-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well remibrutinib works for individuals with a confirmed peanut allergy. It will test whether different doses of the medication help participants tolerate more peanuts without a reaction. Participants will receive either a low, medium, or high dose of remibrutinib, or a placebo (a look-alike pill with no active drug). Those with a history of peanut allergies and positive tests for peanut reactions might be suitable candidates. The trial aims to determine the safety and effectiveness of remibrutinib in managing peanut allergies. As a Phase 2 trial, this research focuses on assessing the treatment's efficacy in an initial, smaller group of people.

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.

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

Research has shown that remibrutinib was safe in previous studies. It is being developed for conditions involving certain immune cells called mast cells and basophils. In these earlier studies, most participants did not experience serious side effects, indicating it was well-tolerated.

When used for other conditions, patients experienced symptom improvements without major safety concerns. Since this study tests remibrutinib for peanut allergies, it is important to note that this is an early stage of research for this specific use. Researchers are closely monitoring its safety to ensure it is safe for participants.

Overall, while remibrutinib appears safe for other conditions, this study will help determine its safety for peanut allergies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peanut allergy?

Remibrutinib is unique because it targets Bruton’s tyrosine kinase (BTK), which plays a crucial role in the allergic response, making it a novel approach for treating peanut allergies. Unlike current treatments that mainly involve avoiding peanuts or undergoing desensitization therapy, remibrutinib offers a potential oral treatment option that directly interferes with the immune response. Researchers are excited because this targeted mechanism could lead to more effective management of peanut allergies with fewer lifestyle disruptions.

What evidence suggests that remibrutinib could be an effective treatment for peanut allergy?

Research shows that remibrutinib may help with allergy-related conditions. In earlier studies, people with chronic spontaneous urticaria (a type of hives) improved as soon as one week after starting remibrutinib, and the treatment remained effective for up to 52 weeks. This trial will evaluate remibrutinib for peanut allergies, with participants receiving different doses of remibrutinib or a placebo. Previous findings indicate that the drug is generally safe for participants, suggesting possible benefits for those with peanut allergies. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive remibrutinib or placebo for a one-month treatment period, with oral food challenges at the beginning and end of the treatment period

4-5 weeks

Multiple visits for dosing and food challenges

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Remibrutinib

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05432388

NCT05432388 | Study of Efficacy, Safety and Tolerability of ... A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy ...

2. novartis.com novartis.com/news/media-releases/novartis-phase-iii-data-confirm-sustained-efficacy-and-long-term-safety-oral-remibrutinib-chronic-spontaneous-urticaria

Novartis Phase III data confirm sustained efficacy and long- ... Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and ...

3. trials.foodallergy.org trials.foodallergy.org/trials/NCT05432388

Study of Efficacy, Safety and Tolerability of Remibrutinib in ... A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05432388?intr=Remibrutinib&rank=5

Study of Efficacy, Safety and Tolerability of Remibrutinib in ... A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy ...

5. jacionline.org jacionline.org/article/S0091-6749(23)01346-5/fulltext

Remibrutinib demonstrates favorable safety profile and ... Remibrutinib demonstrated a consistent favorable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU. Key ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8504815/

Remibrutinib (LOU064): A selective potent oral BTK inhibitor ... Remibrutinib showed encouraging blood and skin PDs with a favorable safety profile, supporting further development for diseases driven by mast cells, basophils ...

7. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/lou

Peanut Allergic Adults Needed For Drug Clinical Trial! This is a month-long study that looks at the safety and efficacy of remibrutinib in adults ages 18-55 years old with peanut allergies.