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