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A 52-week Study of Remibrutinib in IgE-mediated Food Allergy

NCT07768371 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 576

Last updated 2026-08-17

No results posted yet for this study

Summary

The purpose of this Phase III study is to evaluate the clinical efficacy and safety of remibrutinib in participants with peanut, or cow's milk ("milk", cooked and uncooked) or hen's egg ("egg", cooked and uncooked) immunoglobulin E (IgE)- mediated allergy in comparison to placebo.

Conditions

  • IgE-Mediated Food Allergy
  • Peanut Allergy
  • Cow Milk Allergy
  • Egg Allergy

Interventions

DRUG

Remibrutinib

Oral administration of remibrutinib.

DRUG

Placebo

Oral administration of placebo.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-11
Primary Completion
2029-03-30
Completion
2029-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07768371 on ClinicalTrials.gov