Remibrutinib for IgE-mediated peanut, milk, and egg allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, multi-center trial evaluates the safety and efficacy of remibrutinib versus placebo in adolescents and adults with IgE-mediated peanut, milk, or egg allergy. The study runs 52 weeks and includes four sub-studies to test responses to peanut, milk, egg, or a combined peanut/milk/egg challenge at specific timepoints. Participants receive blinded remibrutinib or placebo for up to 24 weeks, followed by an open-label period through Week 52, with an option to join a post-trial access study. Safety follow-up occurs after treatment ends for those not enrolling in post-trial access. Eligibility requires confirmed IgE sensitization, skin test positivity, and a positive double-blind, placebo-controlled food challenge at baseline.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent and/or assent (where applicable) must be obtained prior to study participation. Participant (and parent/legal guardian for adolescents) must be able to understand and provide informed consent and assent, as applicable. If a minor participant providing assent reaches the age of legal majority (as defined by local law), he/she must be re-consented (ICF) at the next study visit.
* Male or female participants who are 12 to 65 years of age, inclusive, at the time of signing informed consent/assent.
* Positive allergen-specific (peanut, milk, or egg), IgE (≥ 0.35 kUA/L) at Screening Visit 1.
* Positive Skin Prick Testing (SPT) for peanut, milk, or egg at Screening Visit 1. This is defined as the average diameter (longest diameter and mid-point orthogonal diameter) ≥ 4 mm wheal compared to the negative control.
* A positive DBPCFC at baseline (Screening Visit 2), defined as the occurrence of dose-limiting symptoms at a single dose:

  * ≤ 100 mg of peanut allergen protein
  * ≤ 300 mg for milk or egg allergen protein
* Participants must be able and willing to participate in the DBPCFC and must be willing to continue avoiding exposure to peanut, milk (cooked and uncooked), or egg (cooked and uncooked) and any other foods that they are allergic to throughout this study.

Exclusion Criteria:

* Previous use of remibrutinib or other Bruton Tyrosine Kinase (BTK) inhibitors.
* History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.
* Hypersensitivity or intolerance to any of the matrix components used within the material for the DBPCFC.
* Any occurrence of dose-limiting symptoms against placebo allergen at baseline DBPCFC (Screening Visit Part 1 and/or Part 2).
* Medical examination, medical conditions or laboratory findings that, in the opinion of the investigator, renders the participant unsuitable for the study.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• AllerVie Clinical Research-Homewood
  Birmingham, Alabama, United States Recruiting
• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Medical Resch of Arizona-Div of Allergy Asthma and Immunology
  Scottsdale, Arizona, United States Recruiting
• Arkansas Childrens Hosp Rsch Inst
  Little Rock, Arkansas, United States Recruiting
• California Allergy and Asthma Medical Group
  Los Angeles, California, United States Recruiting
• Stanford Univ Sean N Parker Center for Allergy and Asthma Re
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.