A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
remibrutinib
+ placebo
Nut and Peanut Hypersensitivity+3
+ Food Hypersensitivity
+ Hypersensitivity
Treatment Study
Summary
Study start date: October 12, 2022
Actual date on which the first participant was enrolled.This is a one month, phase 2, multi-center, randomized, investigator- and participant-blinded, placebo controlled study to assess the safety, efficacy and tolerability of remibrutinib (LOU064) in 3 doses of oral tablet twice a day in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy. Participants will be randomized to remibrutinib low, medium or high dose for one-month treatment period (up to 5 weeks). Participants will have oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.76 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Medical History of allergy to peanuts * Positive peanut IgE \>= 0.35 kUA/L * Positive Skin Prick test for peanut allergen during screening for study * Positive Oral Food Challenge to peanut during screening for study * Willingness to comply with study schedule and procedures and avoid other allergens during study period Exclusion Criteria: * History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening * Uncontrolled asthma * Bleeding risk or coagulation disorder(s) * Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted) * History of splenectomy * Any significant disease that would put the safety of the patient at risk. This includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of GI bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc. Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Arkansas Children's Hospital
Little Rock, United StatesCalifornia Allergy and Asthma Medical Group
Los Angeles, United StatesAllergy and Asthma Clin Res Inc
Walnut Creek, United States