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

• Status: Not yet recruiting
• Trial end date: 2024-09-13
• Target enrollment: 0
• Participant gender: All

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 will be measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Medical History of allergy to peanuts

• Positive peanut IgE >=6kUA/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.