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
2 other identifiers
interventional
76
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2022
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
October 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2025
CompletedMay 20, 2025
May 1, 2025
2.4 years
May 31, 2022
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Responder status defined as tolerating a single dose of \>=600mg of peanut protein without dose-limiting symptoms during the DBPCFC
Baseline and Day 26
Secondary Outcomes (10)
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
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
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
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
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
- +5 more secondary outcomes
Study Arms (5)
remibrutinib low dose
EXPERIMENTALremibrutinib oral tablet
remibrutinib medium dose
EXPERIMENTALremibrutinib oral tablet
remibrutinib high dose
EXPERIMENTALremibrutinib oral tablet
placebo 3 week / remibrutinib low dose 1 week
EXPERIMENTALplacebo oral tablet/ remibrutinib oral tablet
placebo
PLACEBO COMPARATORoral tablet
Interventions
oral tablets
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Allervie Clinical Research
Birmingham, Alabama, 35209, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
California Allergy and Asthma Medical Group
Los Angeles, California, 90025, United States
Allergy and Asthma Clin Res Inc
Walnut Creek, California, 94598, United States
Asthma and Allergy Associates P C
Colorado Springs, Colorado, 80907, United States
Colorado Allergy and Asthma Ctr PC
Denver, Colorado, 80230, United States
Childrens National Hospital
Washington D.C., District of Columbia, 20010, United States
Treasure Valley Medical Research
Boise, Idaho, 83706, United States
Midwest Allergy Sinus Asthma SC
Normal, Illinois, 61761, United States
Asthma and Allergy Center of Chicago S C
River Forest, Illinois, 60305, United States
Bluegrass Allergy Research .
Lexington, Kentucky, 40509, United States
Family Allergy and Asthma
Louisville, Kentucky, 40217, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Institute for Asthma and Allergy PC
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Clinical Trials Office
Ann Arbor, Michigan, 48109, United States
CenExel HRI
Berlin, New Jersey, 08009, United States
Columbia University Irving Medical
New York, New York, 10032, United States
CR Services Acquisition US Main center
Columbus, Ohio, 43213, United States
Vital Prospects Clinical Research Institute
Tulsa, Oklahoma, 74136, United States
Western Sky Medical Research
El Paso, Texas, 79924, United States
Allergy Associates of Utah
Sandy City, Utah, 84093, United States
Seattle Allergy and Asthma Rsch
Seattle, Washington, 98115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2022
First Posted
June 27, 2022
Study Start
October 12, 2022
Primary Completion
March 11, 2025
Study Completion
March 11, 2025
Last Updated
May 20, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com