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

Not Yet RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy

Interventions: Remibrutinib, Placebo

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.