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.
Western Sky Medical Research
Recruiting
El Paso,Texas,79924,United States
Todd Funkhouser
California Allergy and Asthma Medical Group
Recruiting
Los Angeles,California,90025,United States
Ricardo Tan
Asthma and Allergy Center of Chicago S C
Recruiting
River Forest,Illinois,60305,United States
Rachna Shah
Columbia University Irving Medical .
Recruiting
New York,New York,10032,United States
Joyce Yu
Childrens National Hospital
Recruiting
Washington,District of Columbia,20010,United States
Ammara Ahmed
Massachusetts General Hospital Research
Recruiting
Boston,Massachusetts,02114,United States
Wayne Shreffler
Family Allergy and Asthma
Recruiting
Louisville,Kentucky,40217,United States
James Sublett
Treasure Valley Medical Research
Recruiting
Boise,Idaho,83706,United States
Neetu Talreja
Stacy Gonzales
Allergy Associates of Utah
Recruiting
Sandy,Utah,84093,United States
Andrew Smith
Allergy and Asthma Clinical Research Inc
Recruiting
Walnut Creek,California,94598,United States
Joshua S Jacobs
CR Services Acquisition US Main center
Recruiting
Columbus,Ohio,43213,United States
Sridhar Guduri
Allervie Clinical Research
Recruiting
Birmingham,Alabama,35209,United States
John Anderson
University of Michigan Clinical Trials Office Drug Shipment (3)
Recruiting
Ann Arbor,Michigan,48109,United States
Kelly O Shea
Johns Hopkins Hospital
Recruiting
Baltimore,Maryland,21287,United States
Robert Wood
Midwest Allergy Sinus Asthma SC
Recruiting
Normal,Illinois,61761,United States
Dareen D Siri
Asthma and Allergy Associates P C
Recruiting
Colorado Springs,Colorado,80907,United States
Daniel Soteres
Arkansas Children's Hospital Main Centre
Recruiting
Little Rock,Arkansas,72202,United States
Stacie M. Jones
Vital Prospects Clinical Research Institute .
Recruiting
Tulsa,Oklahoma,74136,United States
Iftikhar Hussain
CenExel HRI
Recruiting
Berlin,New Jersey,08009,United States
Michael Hassman
Institute for Asthma and Allergy PC .
Recruiting
Chevy Chase,Maryland,20815,United States
David Jeong
Dustin Battad
Worldwide Contacts
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