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

Last updated: May 19, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Allergy (Pediatric)

Allergy (Peanut)

Allergies & Asthma

Treatment

remibrutinib

placebo

Clinical Study ID

NCT05432388
CLOU064I12201
2021-006950-30
  • Ages 18-55
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 allergensduring study period

Exclusion

Exclusion Criteria:

  • History of severe or life-threatening hypersensitivity event leading to ICUadmission 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. Thisincludes, but is not limited to: history of cancer, significant cardiacdisease/history, hematology disorders, history of GI bleeding, active infectiousprocess, liver disease, renal disease, immunologic disease (stable diabetes andthyroid disease may be permitted), alcohol or drug abuse, etc.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: remibrutinib
Phase: 2
Study Start date:
October 12, 2022
Estimated Completion Date:
March 11, 2025

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Malaga, Andalucia 29009
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28034
    Spain

    Site Not Available

  • Allervie Clinical Research

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Novartis Investigative Site

    Birmingham, Alabama 35209
    United States

    Active - Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's Hospital Main Centre

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

  • Calif Allergy and Asthma Med Grp

    Los Angeles, California 90025
    United States

    Site Not Available

  • California Allergy and Asthma Medical Group

    Los Angeles, California 90025
    United States

    Site Not Available

  • Novartis Investigative Site

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Allergy and Asthma CR Inc

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Allergy and Asthma Clin Res Inc

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Allergy and Asthma Clinical Research Inc

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Asthma and Allergy Associates P C

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Novartis Investigative Site

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Colorado Allergy and Asthma Ctr PC

    Denver, Colorado 80230
    United States

    Site Not Available

  • Novartis Investigative Site

    Denver, Colorado 80230
    United States

    Completed

  • Childrens National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Novartis Investigative Site

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Finlay Medical Research

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Novartis Investigative Site

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Novartis Investigative Site

    Boise, Idaho 83706
    United States

    Active - Recruiting

  • Treasure Valley Medical Research

    Boise, Idaho 83706
    United States

    Site Not Available

  • Midwest Allergy Sinus Asthma SC

    Normal, Illinois 61761
    United States

    Site Not Available

  • Novartis Investigative Site

    Normal, Illinois 61761
    United States

    Active - Recruiting

  • Asthma and Allergy Center of Chicago S C

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Novartis Investigative Site

    River Forest, Illinois 60305
    United States

    Active - Recruiting

  • Bluegrass Allergy Research .

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Novartis Investigative Site

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Family Allergy and Asthma

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Novartis Investigative Site

    Louisville, Kentucky 40217
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Novartis Investigative Site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Institute for Asthma and Allergy PC

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Institute for Asthma and Allergy PC .

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Chevy Chase, Maryland 20815
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital Research

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Novartis Investigative Site

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan Clinical Trials Office

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan Clinical Trials Office Drug Shipment (3)

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan Medical Ctr

    Ann Arbor, Michigan 48109-0922
    United States

    Site Not Available

  • CenExel HRI

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Novartis Investigative Site

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • Columbia University Irving Medical

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Irving Medical .

    New York, New York 10032
    United States

    Active - Recruiting

  • CR Services Acquisition US Main center

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Novartis Investigative Site

    Grove City, Ohio 43123
    United States

    Site Not Available

  • Novartis Investigative Site

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Vital Prospects Clinical Research Institute

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Vital Prospects Clinical Research Institute .

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Novartis Investigative Site

    El Paso, Texas 79924
    United States

    Active - Recruiting

  • Western Sky Medical Research

    El Paso, Texas 79924
    United States

    Site Not Available

  • Allergy Associates of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • Novartis Investigative Site

    Murray, Utah 84107
    United States

    Active - Recruiting

  • Allergy Associates of Utah

    Sandy, Utah 84093
    United States

    Site Not Available

  • Novartis Investigative Site

    Seattle, Washington 98115
    United States

    Active - Recruiting

  • Seattle Allergy and Asthma Rsch

    Seattle, Washington 98115
    United States

    Site Not Available

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