Back to resultsStudy of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
Primary Purpose
Allergy, Peanut
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
remibrutinib
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergy, Peanut focused on measuring Groundnut Hypersensitivity, Hypersensitivity, Peanut, Peanut Allergy, Food Allergy, Oral food challenge, IgE, Remibrutinib, BTKi
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.
Sites / Locations
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
- Novartis Investigative SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
remibrutinib low dose
remibrutinib medium dose
remibrutinib high dose
placebo 3 week / remibrutinib low dose 1 week
placebo
Arm Description
remibrutinib oral tablet
remibrutinib oral tablet
remibrutinib oral tablet
placebo oral tablet/ remibrutinib oral tablet
oral tablet
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
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
Change from baseline at weeks 1 and 4 of peanut specific IgE and IgG4, including peanut components
Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test
Change from screening in skin prick test wheal diameters
Cmax of remibrutinib
Remibrutinib concentrations in blood and PK parameter - Cmax
AUClast of remibrutinib
Remibrutinib concentrations in blood and PK parameter - AUClast
AUCtau of remibrutinib
Remibrutinib concentrations in blood and PK parameter - AUCtau
Tmax of remibrutinib
Remibrutinib concentrations in blood and PK parameter - Tmax
Full Information
NCT ID
NCT05432388
First Posted
May 31, 2022
Last Updated
October 23, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05432388
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
April 29, 2026 (Anticipated)
Study Completion Date
April 29, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy, Peanut
Keywords
Groundnut Hypersensitivity, Hypersensitivity, Peanut, Peanut Allergy, Food Allergy, Oral food challenge, IgE, Remibrutinib, BTKi
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
remibrutinib low dose
Arm Type
Experimental
Arm Description
remibrutinib oral tablet
Arm Title
remibrutinib medium dose
Arm Type
Experimental
Arm Description
remibrutinib oral tablet
Arm Title
remibrutinib high dose
Arm Type
Experimental
Arm Description
remibrutinib oral tablet
Arm Title
placebo 3 week / remibrutinib low dose 1 week
Arm Type
Experimental
Arm Description
placebo oral tablet/ remibrutinib oral tablet
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
remibrutinib
Other Intervention Name(s)
(LOU064)
Intervention Description
oral tablets
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral tablets
Primary Outcome Measure Information:
Title
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
Description
Responder status defined as tolerating a single dose of >=600mg of peanut protein without dose-limiting symptoms during the DBPCFC
Time Frame
Baseline and Day 26
Secondary Outcome Measure Information:
Title
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
Description
Responder status defined as tolerating a single dose of >=1000mg of peanut protein without dose-limiting symptoms during the DBPCFC
Time Frame
Baseline, Days 26 and 28
Title
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
Description
Responder status defined as tolerating a single dose of >=3000mg of peanut protein without dose-limiting symptoms during the DBPCFC
Time Frame
Baseline, Days 26 and 28
Title
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
Description
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 1000mg during the DBPCFC
Time Frame
Baseline, Days 26 and 28
Title
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
Description
Responder status defined as tolerating a single dose of >=600mg peanut protein without dose limiting symptoms during the DBPCFC
Time Frame
Baseline, Days 26 and 28
Title
Effects of multiple doses of remibrutinib compared to placebo, as measured by multiple systemic biomarkers to inform on response to treatment or disease severity
Description
Change from baseline at weeks 1 and 4 of peanut specific IgE and IgG4, including peanut components
Time Frame
Baseline, Days 26 and 28
Title
Ability of remibrutinib to impact skin mast cells through the assessment of allergen-specific skin prick test
Description
Change from screening in skin prick test wheal diameters
Time Frame
Baseline and Day 26
Title
Cmax of remibrutinib
Description
Remibrutinib concentrations in blood and PK parameter - Cmax
Time Frame
Day 8 and Day 25
Title
AUClast of remibrutinib
Description
Remibrutinib concentrations in blood and PK parameter - AUClast
Time Frame
Day 8 and Day 25
Title
AUCtau of remibrutinib
Description
Remibrutinib concentrations in blood and PK parameter - AUCtau
Time Frame
Day 8 and Day 25
Title
Tmax of remibrutinib
Description
Remibrutinib concentrations in blood and PK parameter - Tmax
Time Frame
Day 8 and Day 25
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Facility Information:
Facility Name
Novartis Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Malaga
State/Province
Andalucia
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
Learn more about this trial
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts
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