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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, days 26 and 28
Awards & highlights

Study Summary

This trialtests if a drug can help people with peanut allergies tolerate higher doses of peanut protein.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,846 Previous Clinical Trials
4,194,727 Total Patients Enrolled

Media Library

Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05432388 — Phase 2
Peanut Allergy Research Study Groups: remibrutinib low dose, remibrutinib medium dose, remibrutinib high dose, placebo 3 week / remibrutinib low dose 1 week, placebo
Peanut Allergy Clinical Trial 2023: Remibrutinib Highlights & Side Effects. Trial Name: NCT05432388 — Phase 2
Remibrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05432388 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any of the test subjects in this clinical trial over 20 years old?

"The age bracket for this particular clinical trial is 18 to 55. In total, there are 86 clinical trials involving patients that are minors and 162 concerning senior citizens."

Answered by AI

How does remibrutinib high dose compare to other treatments in terms of safety?

"Remibrutinib high dose falls at a 2 on our 1-3 scale because, although there is some evidence suggesting it is safe, there is no data affirming that the medication is effective."

Answered by AI

Is this research effort actively looking for participants at the moment?

"Yes, the most recent information on clinicaltrials.gov indicates that this trial is still recruiting patients. This particular study was posted on October 12th, 2020 and edited November 2nd, 2020. The goal is to have 110 enrollees at 1 location."

Answered by AI

Who does this clinical trial seek as participants?

"The requirements to take part in this experiment are having a peanut allergy and being between 18-55 years old. So far, 110 individuals have signed up."

Answered by AI
~68 spots leftby Apr 2026