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Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Sponsor: Novartis Pharmaceuticals
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 was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2022-10-12
Completion Date
2025-03-11
Last Updated
2026-06-12
Healthy Volunteers
No
Conditions
Interventions
LOU064
oral tablets
placebo
oral tablets
Locations (24)
Allervie Clinical Research
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
California Allergy and Asthma Medical Group
Los Angeles, California, United States
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Ctr PC
Denver, Colorado, United States
Childrens National Hospital
Washington D.C., District of Columbia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Midwest Allergy Sinus Asthma SC
Normal, Illinois, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, United States
Bluegrass Allergy Research .
Lexington, Kentucky, United States
Bluegrass Allergy Research
Lexington, Kentucky, United States
Family Allergy and Asthma
Louisville, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, United States
CenExel HRI
Berlin, New Jersey, United States
CR Services Acquisition US Main center
Columbus, Ohio, United States
CR Services Acquisition US
Columbus, Ohio, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, United States
Western Sky Medical Research
El Paso, Texas, United States
Allergy Associates of Utah
Sandy City, Utah, United States
Seattle Allergy and Asthma Rsch
Seattle, Washington, United States