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

STUDY OVERVIEW

This phase 2, multi-center, randomized, double-blind, placebo-controlled study by Novartis Pharmaceuticals evaluates the safety, efficacy, and tolerability of three doses of remibrutinib versus placebo in adults with confirmed IgE-mediated peanut allergy. Over a one-month treatment period, participants will receive remibrutinib or placebo twice daily, and their ability to tolerate increasing doses of peanut protein will be assessed through oral food challenges at the start and end of the study.

STUDY GOALS

The goal of this study is to evaluate the safety, efficacy, and tolerability of three doses of remibrutinib compared to placebo in adults with confirmed peanut allergy.

LOCATION

El Paso, Texas: Western Sky Medical Research

INCLUSION CRITERIA

  • Medical history of peanut allergy.

  • Positive peanut IgE ≥ 0.35 kUA/L.

  • Positive skin prick test for peanut allergen during screening.

  • Positive oral food challenge to peanut during screening.

  • Willingness to comply with study schedule and avoid other allergens during the study.

exclusion criteria

  • History of severe or life-threatening hypersensitivity event requiring ICU admission or intubation within 60 days of screening.

  • Uncontrolled asthma.

  • Bleeding risk or coagulation disorders.

  • Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted).

  • History of splenectomy.

  • Significant disease posing a safety risk, including but not limited to: cancer, significant cardiac disease, hematology disorders, GI bleeding, active infection, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), or alcohol/drug abuse.

Other protocol-defined criteria may apply.

For more information, visit ClinicalTrials.gov.