NCT07768371 A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
| NCT ID | NCT07768371 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | IgE-Mediated Food Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 576 participants |
| Start Date | 2026-08-27 |
| Primary Completion | 2029-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 576 participants in total. It began in 2026-08-27 with a primary completion date of 2029-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07768371 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 65 Years, studying IgE-Mediated Food Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07768371 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 576 participants.
Is NCT07768371 currently recruiting?
Yes, NCT07768371 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07768371 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Los Angeles, United States, Chevy Chase, United States and 4 additional locations.
Who is sponsoring the NCT07768371 clinical trial?
NCT07768371 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 576 participants.