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A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
Sponsor: Novartis Pharmaceuticals
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.
Official title: A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy and Safety of Remibrutinib (LOU064) in Adult and Adolescent Participants With IgE-mediated Food Allergy
Key Details
Gender
All
Age Range
12 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
576
Start Date
2026-08-27
Completion Date
2029-12-31
Last Updated
2026-09-25
Healthy Volunteers
No
Interventions
Remibrutinib
Oral administration of remibrutinib.
Placebo
Oral administration of placebo.
Locations (14)
Allervie Clinical Research
Birmingham, Alabama, United States
Medical Resch of Arizona-Div of Allergy Asthma and Immunology
Scottsdale, Arizona, United States
Arkansas Childrens Hosp Rsch Inst
Little Rock, Arkansas, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Childrens Healthcare Of Atlanta
Atlanta, Georgia, United States
Sneeze Wheeze Itch Asso LLC
Normal, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States
Weiss Medical
Riverdale, New Jersey, United States
Northwell Health
New York, New York, United States
Montefiore Health System
The Bronx, New York, United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina, United States
Western Sky Medical Research
El Paso, Texas, United States