Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

Completed · Phase 2 · Has a placebo group

Conditions studied: Allergy, Peanut

In brief

A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

Key facts

Study ID

NCT05432388

Run by

Novartis Pharmaceuticals

People needed

76

Starts

2022-10-12

Expected to finish

2025-03-11

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Medical History of allergy to peanuts
• Positive peanut IgE >= 0.35 kUA/L
• Positive Skin Prick test for peanut allergen during screening for study
• Positive Oral Food Challenge to peanut during screening for study
• Willingness to comply with study schedule and procedures and avoid other allergens during study period

You may not qualify if…

• History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening
• Uncontrolled asthma
• Bleeding risk or coagulation disorder(s)
• Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted)
• History of splenectomy
• Any significant disease that would put the safety of the patient at risk. This includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of GI bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Allervie Clinical Research — Birmingham, Alabama, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• California Allergy and Asthma Medical Group — Los Angeles, California, United States
• Allergy and Asthma Clin Res Inc — Walnut Creek, California, United States
• Asthma and Allergy Associates P C — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Ctr PC — Denver, Colorado, United States
• Childrens National Hospital — Washington D.C., District of Columbia, United States
• Treasure Valley Medical Research — Boise, Idaho, United States
• Midwest Allergy Sinus Asthma SC — Normal, Illinois, United States
• Asthma and Allergy Center of Chicago S C — River Forest, Illinois, United States
• Bluegrass Allergy Research . — Lexington, Kentucky, United States
• Bluegrass Allergy Research — Lexington, Kentucky, United States
• Family Allergy and Asthma — Louisville, Kentucky, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Institute for Asthma and Allergy PC — Chevy Chase, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Clinical Trials Office — Ann Arbor, Michigan, United States
• CenExel HRI — Berlin, New Jersey, United States
• CR Services Acquisition US Main center — Columbus, Ohio, United States
• CR Services Acquisition US — Columbus, Ohio, United States
• Vital Prospects Clinical Research Institute — Tulsa, Oklahoma, United States
• Western Sky Medical Research — El Paso, Texas, United States
• Allergy Associates of Utah — Sandy City, Utah, United States
• Seattle Allergy and Asthma Rsch — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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