Study Description
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 will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
Interventions
placebo
remibrutinib
Eligibility 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 Location
Novartis Investigative Site
Recruiting
Madrid,28034,Spain
Novartis Investigative Site
Recruiting
Barcelona,Catalunya,08035,Spain
Novartis Investigative Site
Recruiting
Malaga,Andalucia,29009,Spain
Novartis Investigative Site
Recruiting
Little Rock,Arkansas,72202,United States
Novartis Investigative Site
Recruiting
Boise,Idaho,83706,United States
Novartis Investigative Site
Recruiting
River Forest,Illinois,60305,United States
Novartis Investigative Site
Recruiting
Los Angeles,California,90025,United States
Novartis Investigative Site
Recruiting
Boston,Massachusetts,02114,United States
Novartis Investigative Site
Recruiting
Seattle,Washington,98115,United States
Novartis Investigative Site
Recruiting
Louisville,Kentucky,40217,United States
Novartis Investigative Site
Recruiting
Chevy Chase,Maryland,20815,United States
Novartis Investigative Site
Recruiting
Tulsa,Oklahoma,74136,United States
Novartis Investigative Site
Recruiting
Baltimore,Maryland,21287,United States
Novartis Investigative Site
Recruiting
El Paso,Texas,79912,United States
Novartis Investigative Site
Recruiting
Grove City,Ohio,43123,United States
Novartis Investigative Site
Recruiting
Berlin,New Jersey,08009,United States
Novartis Investigative Site
Recruiting
Murray,Utah,84107,United States
Novartis Investigative Site
Recruiting
Lexington,Kentucky,40509,United States
Novartis Investigative Site
Recruiting
Birmingham,Alabama,35209,United States
Novartis Investigative Site
Recruiting
Normal,Illinois,61761,United States
Worldwide Contacts
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