remibrutinib high dose for Peanut Allergies

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Peanut Allergies+2 More
remibrutinib - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

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 peanuts. The efficacy will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

Eligible Conditions
  • Peanut Allergies

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Peanut Allergies

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Baseline, Days 26 and 28

Baseline and Day 26
Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test
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
Day 26
Effects of multiple doses of remibrutinib compared to placebo, as measured by multiple systemic biomarkers to inform on response to treatment or disease severity
Efficacy of 3 weeks placebo treatment followed by 1 week of oral remibrutinib treatment compared to placebo as measured by the proportion of participants who can tolerate a single dose of >=600mg peanut protein during DBPCFC
Efficacy or oral remibrutinib compared to placebo as measured by the madimum symptoms severity at any single challenged dose up to and including 1000mg of peanut protein
Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=1000mg of peanut protein without dose-limiting symptoms during DBPCFC
Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=3000mg of peanut protein without dose-limiting symptoms during DBPCFC
Day 25
AUClast of remibrutinib
AUCtau of remibrutinib
Cmax of remibrutinib
Tmax of remibrutinib

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Peanut Allergies

Trial Design

5 Treatment Groups

remibrutinib high dose
1 of 5
placebo 3 week / remibrutinib low dose 1 week
1 of 5
remibrutinib medium dose
1 of 5
remibrutinib low dose
1 of 5
placebo
1 of 5
Experimental Treatment
Non-Treatment Group

110 Total Participants · 5 Treatment Groups

Primary Treatment: remibrutinib high dose · Has Placebo Group · Phase 2

remibrutinib high dose
Drug
Experimental Group · 1 Intervention: remibrutinib · Intervention Types: Drug
placebo 3 week / remibrutinib low dose 1 weekExperimental Group · 2 Interventions: remibrutinib, placebo · Intervention Types: Drug, Drug
remibrutinib medium dose
Drug
Experimental Group · 1 Intervention: remibrutinib · Intervention Types: Drug
remibrutinib low dose
Drug
Experimental Group · 1 Intervention: remibrutinib · Intervention Types: Drug
placebo
Drug
PlaceboComparator Group · 1 Intervention: placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
placebo
2010
Completed Phase 4
~6450

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, days 26 and 28

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,692 Previous Clinical Trials
3,522,929 Total Patients Enrolled
3 Trials studying Peanut Allergies
711 Patients Enrolled for Peanut Allergies

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to comply with study schedule and procedures and avoid other allergens during study period.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.