A 52-week Study of Remibrutinib in IgE-mediated Food Allergy
Novartis Pharmaceuticals · NCT07768371
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 12–65 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 576
- US sites recruiting
- 18
- Study start
- August 27, 2026
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Remibrutinib; Placebo
Conditions: IgE-Mediated Food Allergy; Peanut Allergy; Cow Milk Allergy; Egg Allergy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
AllerVie Clinical Research-Homewood
Birmingham, AL 35209
Site contact: Esther Patterson Lange · +1 205 871 9661 · elange@allervie.com
Medical Resch of Arizona-Div of Allergy Asthma and Immunology
Scottsdale, AZ 85251
Site contact: Jasmine Hernandez · +1 480 889 6313 · jas@medicalresearchaz.com
Arkansas Childrens Hosp Rsch Inst
Little Rock, AR 72202
Site contact: Erin Thomas · +1 501 978 6413 · ThomasES@archildrens.org
California Allergy and Asthma Medical Group
Los Angeles, CA 90025
Site contact: Vivienne An · +1 310 966 9050 · viviennean@calallergy.com
Asthma and Allergy Associates P C
Colorado Springs, CO 80907
Site contact: Sneha Tata · +1 719 473 8330 · STata@aacos.com
Childrens Healthcare Of Atlanta
Atlanta, GA 30329
Site contact: Ashley Dulson · Ashley.Dulson@choa.org
Sneeze Wheeze Itch Asso LLC
Normal, IL 61761
Site contact: Stephanie Oliver · stephanieoliver@asthma2.com
Asthma and Allergy Center of Chicago S C
River Forest, IL 60305
Site contact: Emily Rodriguez · emily@asthmaallergycenterofchicago.com
Johns Hopkins Hospital
Baltimore, MD 21287
Site contact: Gledson Hanelt · ghanelt1@jhu.edu
Institute for Asthma and Allergy PC
Chevy Chase, MD 20815
Site contact: Amy Tran · iaaresearchatran@gmail.com
Childrens Hosp Boston Dept of Heme
Boston, MA 02115
Site contact: Sidney Wang · +1 617 355 7700 · sidney.wang@childrens.harvard.edu
Respiratory Medicine Research Institute of Michigan
Ypsilanti, MI 48197
Site contact: Diana Grigoryan · +1 734 434 3007 · dgrigoryan@annarborallergy.com
Impact Medical - Circuit Clinical
Riverdale, NJ 07457
Site contact: Melba Ventura · mventura@circuitclinical.com
Northwell Health
New York, NY 10028
Site contact: Aaqil Ali · +1 516 622 5064 · aali27@northwell.edu
Montefiore Health System
The Bronx, NY 10461
Site contact: Patricia Pallo · ppallor@montefiore.org
National Allergy and Asthma Research LLS
North Charleston, SC 29420
Site contact: Faye Singleton · +1 843 820 1036 · fsingleton@nationalallergyandent.com
Western Sky Medical Research
El Paso, TX 79924
Site contact: Laura Herrera · lherrera@westernskymed.com
Allergy Associates of Utah
Sandy City, UT 84093
Site contact: Rylee Roper · +1 801 263 8700 · rylee.roper@utahallergies.com
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111 · novartis.email@novartis.com