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. This is a one month, phase 2, multi-center, randomized, investigator- and
participant-blinded, placebo controlled study to assess the safety, efficacy and
tolerability of remibrutinib (LOU064) in 3 doses of oral tablet twice a day in
participants with a medically confirmed diagnosis of IgE-mediated peanut allergy.
Participants will be randomized to remibrutinib low, medium or high dose for one-month
treatment period (up to 5 weeks). Participants will have oral food challenges at the
beginning of the study and at the end of the treatment period to assess their symptoms
from increasing doses of peanut allergen.
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.
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