Last Update: May 22, 2024
A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLOU064I12201
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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.

Allergy, Peanut
Phase2
Recruiting
72
Oct 12, 2022
Feb 03, 2025
All
18 Years - 55 Years (Adult)

Interventions

Drug

placebo

oral tablets
Drug

remibrutinib

oral tablets

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

Bluegrass Allergy Research .

Recruiting

Lexington,Kentucky,40509,United States

Jazzmen Wilson
William A Greisner III

Family Allergy and Asthma

Recruiting

Louisville,Kentucky,40217,United States

Lisa Boon
James Sublett

Vital Prospects Clinical Research Institute .

Recruiting

Tulsa,Oklahoma,74136,United States

Beverly Solis
Iftikhar Hussain

Arkansas Children's Hospital Main Centre

Recruiting

Little Rock,Arkansas,72202,United States

Berenice Alfaro
Stacie M. Jones

Childrens National Hospital

Recruiting

Washington,District of Columbia,20010,United States

Ammara Ahmed
Amanda Troger

Allergy and Asthma CR Inc

Recruiting

Walnut Creek,California,94598,United States

John Woll
Joshua S Jacobs

Midwest Allergy Sinus Asthma SC

Recruiting

Normal,Illinois,61761,United States

Andrew Lanier
Dareen D Siri

Institute for Asthma and Allergy PC .

Recruiting

Chevy Chase,Maryland,20815,United States

David Jeong
Dustin Battad

Columbia University Irving Medical .

Recruiting

New York,New York,10032,United States

Joyce Yu

Calif Allergy and Asthma Med Grp

Recruiting

Los Angeles,California,90025,United States

Ricardo Tan
Sharon Short

Asthma and Allergy Associates P C

Recruiting

Colorado Springs,Colorado,80907,United States

Daniel Soteres
Lauren Utter

Western Sky Medical Research

Recruiting

El Paso,Texas,79924,United States

Michelle Huerta
Todd Funkhouser

Allergy Associates of Utah

Recruiting

Murray,Utah,84107,United States

Andrew Smith
Sandy Warr

Treasure Valley Medical Research

Recruiting

Boise,Idaho,83706,United States

Abreenah Magdaleno
Neetu Talreja

Johns Hopkins Hospital

Recruiting

Baltimore,Maryland,21287,United States

Kim Mudd
Robert Wood

CR Services Acquisition US Main center

Recruiting

Columbus,Ohio,43213,United States

Kylie Wentworth
Sridhar Guduri

CenExel HRI

Recruiting

Berlin,New Jersey,08009,United States

Kelly Schwartz
Michael Hassman

Asthma and Allergy Center of Chicago S C

Recruiting

River Forest,Illinois,60305,United States

Phillip Waters
Rachna Shah

University of Michigan Medical Ctr

Recruiting

Ann Arbor,Michigan,48109-0922,United States

Kelly O Shea
Keri Haines

Allervie Clinical Research

Recruiting

Birmingham,Alabama,35209,United States

Brittany Scott
John Anderson

Massachusetts General Hospital Research

Recruiting

Boston,Massachusetts,02114,United States

Elizabeth Moseley
Wayne Shreffler

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