Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental remibrutinib low dose |
remibrutinib oral tablet |
|
|
Experimental remibrutinib medium dose |
remibrutinib oral tablet |
|
|
Experimental remibrutinib high dose |
remibrutinib oral tablet |
|
|
Experimental placebo 3 week / remibrutinib low dose 1 week |
placebo oral tablet/ remibrutinib oral tablet |
|
|
Placebo Comparator placebo |
oral tablet |
|
Recruiting Locations
Children's National and nearby locations
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT05432388
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
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 doses of oral tablet twice a day in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy. Participants will be randomized to remibrutinib low, medium or high dose for one-month treatment period (up to 5 weeks). Participants will have oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.