Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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.