Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
- Registration Number
- NCT05432388
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo 3 week / remibrutinib low dose 1 week placebo placebo oral tablet/ remibrutinib oral tablet placebo 3 week / remibrutinib low dose 1 week remibrutinib placebo oral tablet/ remibrutinib oral tablet placebo placebo oral tablet remibrutinib high dose remibrutinib remibrutinib oral tablet remibrutinib low dose remibrutinib remibrutinib oral tablet remibrutinib medium dose remibrutinib remibrutinib oral tablet
- Primary Outcome Measures
Name Time Method 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 Baseline and Day 26 Responder status defined as tolerating a single dose of \>=600mg of peanut protein without dose-limiting symptoms during the DBPCFC
- Secondary Outcome Measures
Name Time Method 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 Baseline, Days 26 and 28 Responder status defined as tolerating a single dose of \>=1000mg of peanut protein without dose-limiting symptoms during the DBPCFC
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 Baseline, Days 26 and 28 Responder status defined as tolerating a single dose of \>=3000mg of peanut protein without dose-limiting symptoms during the DBPCFC
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 Baseline, Days 26 and 28 Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000mg during the DBPCFC
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 Baseline, Days 26 and 28 Responder status defined as tolerating a single dose of \>=600mg peanut protein without dose limiting symptoms during the DBPCFC
Effects of multiple doses of remibrutinib compared to placebo, as measured by multiple systemic biomarkers to inform on response to treatment or disease severity Baseline, Days 26 and 28 Change from baseline at weeks 1 and 4 of peanut specific IgE and IgG4, including peanut components
Cmax of remibrutinib Day 8 and Day 25 Remibrutinib concentrations in blood and PK parameter - Cmax
AUClast of remibrutinib Day 8 and Day 25 Remibrutinib concentrations in blood and PK parameter - AUClast
Tmax of remibrutinib Day 8 and Day 25 Remibrutinib concentrations in blood and PK parameter - Tmax
Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test Baseline and Day 26 Change from screening in skin prick test wheal diameters
AUCtau of remibrutinib Day 8 and Day 25 Remibrutinib concentrations in blood and PK parameter - AUCtau
Trial Locations
- Locations (25)
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Institute for Asthma and Allergy PC
🇺🇸Chevy Chase, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Clinical Trials Office
🇺🇸Ann Arbor, Michigan, United States
Columbia University Irving Medical
🇺🇸New York, New York, United States
Vital Prospects Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Allervie Clinical Research
🇺🇸Birmingham, Alabama, United States
California Allergy and Asthma Medical Group
🇺🇸Los Angeles, California, United States
Allergy and Asthma Clinical Research Inc
🇺🇸Walnut Creek, California, United States
Asthma and Allergy Associates P C
🇺🇸Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Ctr PC
🇺🇸Denver, Colorado, United States
Childrens National Hospital
🇺🇸Washington, District of Columbia, United States
Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
Midwest Allergy Sinus Asthma SC
🇺🇸Normal, Illinois, United States
Asthma and Allergy Center of Chicago S C
🇺🇸River Forest, Illinois, United States
Bluegrass Allergy Research .
🇺🇸Lexington, Kentucky, United States
Family Allergy and Asthma
🇺🇸Louisville, Kentucky, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
CenExel HRI
🇺🇸Berlin, New Jersey, United States
CR Services Acquisition US Main center
🇺🇸Columbus, Ohio, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Allergy Associates of Utah
🇺🇸Sandy, Utah, United States
Seattle Allergy and Asthma Rsch
🇺🇸Seattle, Washington, United States
Novartis Investigative Site
🇪🇸Madrid, Spain