A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
Start Date
8/27/2026
Completion Date
12/31/2029
Summary
The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo.
Detailed Description
This study is a Phase III, 52-week, multi-center, placebo controlled pivotal study to evaluate the efficacy and safety of remibrutinib compared to placebo in adolescent and adult participants with peanut, milk, or egg IgE-mediated allergy. This study will be conducted in 4 Sub-studies: Sub-study 1 to evaluate response to peanut allergen at Week 24, Sub-study 2 to evaluate response to milk allergen at Week 24, Sub-study 3 to evaluate response to egg allergen at Week 24, and Sub-study 4 to evaluate response to peanut or milk, or egg allergen at Week 4. Treatment period 1: Participants will receive one of the two treatment groups, double-blind remibrutinib or placebo, for a period up to 24 weeks for Sub-studies 1, 2, and 3, and up to 4 weeks for Sub-study 4. Treatment period 2: For all Sub-studies, the open label period starts at Week 24, except for Sub-study 4, where the open label period starts at Week 4. Participants from each Sub-study will continue in the study and receive, or initiate, active open label remibrutinib until Week 52. Following completion of the treatment period 2, eligible participants may enroll in a separate open-label post-trial access study and receive remibrutinib to evaluate long-term treatment effects. Participants who do not enroll in the post-trial access study will enter a 4-week safety follow-up period off treatment, during which adverse events will be monitored.
Eligibility Criteria
Age Range: 12 years to 65 years
Interventions
Remibrutinib
Placebo
Conditions
Locations
AllerVie Clinical Research-Homewood
Birmingham, Alabama 35209
United States
Medical Resch of Arizona-Div of Allergy Asthma and Immunology
Scottsdale, Arizona 85251
United States
Arkansas Childrens Hosp Rsch Inst
Little Rock, Arkansas 72202
United States
California Allergy and Asthma Medical Group
Los Angeles, California 90025
United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado 80907
United States
Childrens Healthcare Of Atlanta
Atlanta, Georgia 30329
United States
Sneeze Wheeze Itch Asso LLC
Normal, Illinois 61761
United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois 60305
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland 20815
United States
Childrens Hosp Boston Dept of Heme
Boston, Massachusetts 02115
United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan 48197
United States
Impact Medical - Circuit Clinical
Riverdale, New Jersey 07457
United States
Northwell Health
New York, New York 10028
United States
Montefiore Health System
The Bronx, New York 10461
United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina 29420
United States
Western Sky Medical Research
El Paso, Texas 79924
United States
Allergy Associates of Utah
Sandy City, Utah 84093
United States