Clinical trial NCT05432388: Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergy, Peanut
Keywords: Groundnut Hypersensitivity
Hypersensitivity, Peanut
Peanut Allergy
Food Allergy
Oral food challenge
IgE
Remibrutinib
BTKi
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-06-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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.

Primary outcomes:
measure: Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=600mg of peanut protein without dose-limiting symptoms during DBPCFC
timeFrame: Baseline and Day 26
Secondary outcomes:
measure: Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=1000mg of peanut protein without dose-limiting symptoms during DBPCFC
timeFrame: Baseline, Days 26 and 28
measure: Efficacy or oral remibrutinib compared to placebo, as measured by the proportion of participants who can tolerate a single dose of >=3000mg of peanut protein without dose-limiting symptoms during DBPCFC
timeFrame: Baseline, Days 26 and 28
measure: Efficacy or oral remibrutinib compared to placebo as measured by the madimum symptoms severity at any single challenged dose up to and including 1000mg of peanut protein
timeFrame: Baseline, Days 26 and 28
measure: Efficacy of 3 weeks placebo treatment followed by 1 week of oral remibrutinib treatment compared to placebo as measured by the proportion of participants who can tolerate a single dose of >=600mg peanut protein during DBPCFC
timeFrame: Baseline, Days 26 and 28
measure: Effects of multiple doses of remibrutinib compared to placebo, as measured by multiple systemic biomarkers to inform on response to treatment or disease severity
timeFrame: Baseline, Days 26 and 28
measure: Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test
timeFrame: Baseline and Day 26
measure: Cmax of remibrutinib
timeFrame: Day 8 and Day 25
measure: AUClast of remibrutinib
timeFrame: Day 8 and Day 25
measure: AUCtau of remibrutinib
timeFrame: Day 8 and Day 25
measure: Tmax of remibrutinib
timeFrame: Day 8 and Day 25
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Allervie Clinical Research
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clin Res Inc
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates P C
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Ctr PC
state: Colorado
city: Washington
country: United States
facility: Childrens National Hospital
state: District of Columbia
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Normal
country: United States
facility: Midwest Allergy Sinus Asthma SC
state: Illinois
city: River Forest
country: United States
facility: Asthma and Allergy Center of Chicago S C
state: Illinois
city: Lexington
country: United States
facility: Bluegrass Allergy Research .
state: Kentucky
city: Louisville
country: United States
facility: Family Allergy and Asthma
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy PC
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Clinical Trials Office
state: Michigan
city: Berlin
country: United States
facility: CenExel HRI
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical
state: New York
city: Columbus
country: United States
facility: CR Services Acquisition US Main center
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute
state: Oklahoma
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Sandy
country: United States
facility: Allergy Associates of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Allergy and Asthma Rsch
state: Washington
Study officials:
References: