A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-65
SponsorNovartis Pharmaceuticals
About this trial
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
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Remibrutinib
- Placebo
Treatment groups
576 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov