Children's National

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

Purpose

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.

Condition

Allergy, Peanut

Eligibility

Eligible Ages: Between 18 Years and 55 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Care Provider, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental remibrutinib low dose	remibrutinib oral tablet	Drug: remibrutinib oral tablets Other names: (LOU064)
Experimental remibrutinib medium dose	remibrutinib oral tablet	Drug: remibrutinib oral tablets Other names: (LOU064)
Experimental remibrutinib high dose	remibrutinib oral tablet	Drug: remibrutinib oral tablets Other names: (LOU064)
Experimental placebo 3 week / remibrutinib low dose 1 week	placebo oral tablet/ remibrutinib oral tablet	Drug: remibrutinib oral tablets Other names: (LOU064) Drug: placebo oral tablets
Placebo Comparator placebo	oral tablet	Drug: placebo oral tablets

Recruiting Locations

Children's National and nearby locations

Childrens National Hospital
Washington, District of Columbia 20010

Contact:
Amanda Troger
202-476-5000
atroger@childrensnational.org

More Details

NCT ID: NCT05432388
Status: Recruiting
Sponsor: Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.