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

NCT05432388 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CLOU064I122012021-006950-30
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 24

Brief 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 was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

Conditions

Allergy, Peanut

Keywords

Groundnut Hypersensitivity; Hypersensitivity, Peanut; Peanut Allergy; Food Allergy; Oral food challenge; IgE; Remibrutinib; BTKi

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms

  Responder rate was defined as the percentage of participants tolerating a single dose of \>= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.

  Week 4

Secondary Outcomes (12)

• Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms

  Week 4

• Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms

  Week 4

• Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo

  Week 4

• Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC

  4 weeks

• Change From Baseline of Peanut-specific IgE (Including Peanut Components)

  Baseline, Day 25 pre-dose and Day 31 (End of Study)

Study Arms (5)

LOU064 10 mg

EXPERIMENTAL

LOU064 10 mg was administered orally twice per day, on Days 1 through 28.

Drug: LOU064

LOU064 25 mg

EXPERIMENTAL

LOU064 25 mg was administered orally twice per day, on Days 1 through 28.

Drug: LOU064

LOU064 100 mg

EXPERIMENTAL

LOU064 100 mg was administered orally twice per day, on Days 1 through 28.

Drug: LOU064

Placebo + LOU064 25 mg

EXPERIMENTAL

Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.

Drug: LOU064; Drug: placebo

Placebo

PLACEBO COMPARATOR

Placebo was administered orally twice per day, on Days 1 through 28.

Drug: placebo

Interventions

LOU064 DRUG

oral tablets

Also known as: remibrutinib

LOU064 10 mg; LOU064 100 mg; LOU064 25 mg; Placebo + LOU064 25 mg

placebo DRUG

oral tablets

Placebo; Placebo + LOU064 25 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (24)

Allervie Clinical Research

Birmingham, Alabama, 35209, United States

Location

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

Allergy and Asthma Clin Res Inc

Walnut Creek, California, 94598, United States

Location

Asthma and Allergy Associates P C

Colorado Springs, Colorado, 80907, United States

Location

Colorado Allergy and Asthma Ctr PC

Denver, Colorado, 80230, United States

Location

Childrens National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

Midwest Allergy Sinus Asthma SC

Normal, Illinois, 61761, United States

Location

Asthma and Allergy Center of Chicago S C

River Forest, Illinois, 60305, United States

Location

Bluegrass Allergy Research .

Lexington, Kentucky, 40509, United States

Location

Bluegrass Allergy Research

Lexington, Kentucky, 40509, United States

Location

Family Allergy and Asthma

Louisville, Kentucky, 40217, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Institute for Asthma and Allergy PC

Chevy Chase, Maryland, 20815, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan Clinical Trials Office

Ann Arbor, Michigan, 48109, United States

Location

CenExel HRI

Berlin, New Jersey, 08009, United States

Location

CR Services Acquisition US Main center

Columbus, Ohio, 43213, United States

Location

CR Services Acquisition US

Columbus, Ohio, 43213, United States

Location

Vital Prospects Clinical Research Institute

Tulsa, Oklahoma, 74136, United States

Location

Western Sky Medical Research

El Paso, Texas, 79924, United States

Location

Allergy Associates of Utah

Sandy City, Utah, 84093, United States

Location

Seattle Allergy and Asthma Rsch

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 27, 2022
• Study Start: October 12, 2022
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: June 12, 2026
• Results First Posted: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (24)