Status:
COMPLETED
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Allergy, Peanut
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a one month, phase 2, multi-center, randomized, investigator- and participant-blinded, placebo controlled study to assess the safety, efficacy and tolerability of remibrutinib (LOU064) in 3 do...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2025
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05432388
Start Date
October 12 2022
End Date
March 11 2025
Last Update
May 20 2025
Active Locations (23)
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1
Allervie Clinical Research
Birmingham, Alabama, United States, 35209
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
California Allergy and Asthma Medical Group
Los Angeles, California, United States, 90025
4
Allergy and Asthma Clin Res Inc
Walnut Creek, California, United States, 94598