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Completed NCT05432388

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

Conditions: Allergy, Peanut

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 76
Sponsor: Novartis Pharmaceuticals

Location: Allervie Clinical Research Birmingham Alabama

Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05432388). StuddyBuddy aggregates publicly available trial information.