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

A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy

ClinicalTrials.gov Identifier: NCT05432388

Novartis Reference Number: CLOU064I12201

Last Update: Nov 04, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Allergy, Peanut
Phase 
Phase 2
Overall status 
Recruiting
Start date 
Oct 12, 2022
Completion date 
Sep 13, 2024
Gender 
All
Age(s)
18 Years - 55 Years (Adult)

Interventions

Drug
remibrutinib
oral tablets
Drug
placebo
oral tablets

Eligibility 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.

Study Locations

United States
Western Sky Medical Research
Recruiting
El Paso, 79903 - Texas
Contact: Todd Funkhouser
United States

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]