Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
NCT ID: NCT05432388
Last Updated: 2025-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2022-10-12
2025-03-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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remibrutinib low dose
remibrutinib oral tablet
remibrutinib
oral tablets
remibrutinib medium dose
remibrutinib oral tablet
remibrutinib
oral tablets
remibrutinib high dose
remibrutinib oral tablet
remibrutinib
oral tablets
placebo 3 week / remibrutinib low dose 1 week
placebo oral tablet/ remibrutinib oral tablet
remibrutinib
oral tablets
placebo
oral tablets
placebo
oral tablet
placebo
oral tablets
Interventions
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remibrutinib
oral tablets
placebo
oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
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
Columbia University Irving Medical
New York, New York, United States
CR Services Acquisition US Main center
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
Countries
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Other Identifiers
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2021-006950-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLOU064I12201
Identifier Type: -
Identifier Source: org_study_id
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