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

Novartis Pharmaceuticals76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Allergy, Peanut

Interventions

remibrutinibDRUG

oral tablets

placeboDRUG

oral tablets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (23)

Allervie Clinical Research

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=600mg of peanut protein without dose-limiting symptoms during DBPCFC

Responder status defined as tolerating a single dose of \>=600mg of peanut protein without dose-limiting symptoms during the DBPCFC

Time frame: Baseline and Day 26

Secondary Outcomes

Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=1000mg of peanut protein without dose-limiting symptoms during DBPCFC

Responder status defined as tolerating a single dose of \>=1000mg of peanut protein without dose-limiting symptoms during the DBPCFC

Time frame: Baseline, Days 26 and 28

Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=3000mg of peanut protein without dose-limiting symptoms during DBPCFC

Responder status defined as tolerating a single dose of \>=3000mg of peanut protein without dose-limiting symptoms during the DBPCFC

Time frame: Baseline, Days 26 and 28

Efficacy or oral remibrutinib compared to placebo as measured by the madimum symptoms severity at any single challenged dose up to and including 1000mg of peanut protein

Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000mg during the DBPCFC

Time frame: Baseline, Days 26 and 28

Efficacy of 3 weeks placebo treatment followed by 1 week of oral remibrutinib treatment compared to placebo as measured by the proportion of participants who can tolerate a single dose of >=600mg peanut protein during DBPCFC

Responder status defined as tolerating a single dose of \>=600mg peanut protein without dose limiting symptoms during the DBPCFC

Data from ClinicalTrials.gov

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