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

CompletedPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Allergy, Peanut

Interventions: LOU064, placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (24)

Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Boise, Idaho, United States
Normal, Illinois, United States
River Forest, Illinois, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Berlin, New Jersey, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
El Paso, Texas, United States
Sandy City, Utah, United States
Seattle, Washington, United States