Last Update: Jan 23, 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
Phase 2
Recruiting
110
Oct 12, 2022
Apr 29, 2026
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

Novartis Investigative Site

Recruiting

Barcelona,Catalunya,08035,Spain

Novartis Investigative Site

Recruiting

Madrid,28034,Spain

Novartis Investigative Site

Recruiting

Malaga,Andalucia,29009,Spain

Novartis Investigative Site

Recruiting

Los Angeles,California,90025,United States

Novartis Investigative Site

Recruiting

Chevy Chase,Maryland,20815,United States

Novartis Investigative Site

Recruiting

Seattle,Washington,98115,United States

Novartis Investigative Site

Recruiting

Baltimore,Maryland,21287,United States

Novartis Investigative Site

Recruiting

Louisville,Kentucky,40217,United States

Novartis Investigative Site

Recruiting

Colorado Springs,Colorado,80907,United States

Novartis Investigative Site

Recruiting

Tulsa,Oklahoma,74136,United States

Novartis Investigative Site

Recruiting

El Paso,Texas,79924,United States

Novartis Investigative Site

Recruiting

Washington,District of Columbia,20010,United States

Novartis Investigative Site

Recruiting

Berlin,New Jersey,08009,United States

Novartis Investigative Site

Recruiting

Grove City,Ohio,43123,United States

Novartis Investigative Site

Recruiting

Birmingham,Alabama,35209,United States

Novartis Investigative Site

Recruiting

Murray,Utah,84107,United States

Novartis Investigative Site

Recruiting

Lexington,Kentucky,40509,United States

Novartis Investigative Site

Recruiting

Boise,Idaho,83706,United States

Novartis Investigative Site

Recruiting

Normal,Illinois,61761,United States

Novartis Investigative Site

Recruiting

Little Rock,Arkansas,72202,United States

Novartis Investigative Site

Recruiting

Boston,Massachusetts,02114,United States

Novartis Investigative Site

Recruiting

River Forest,Illinois,60305,United States

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