Study of Efficacy, Safety and Tolerability of Remibrutini... | NCT05432388 | Trialant
NCT05432388
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Jun 12, 2026Actual
Enrollment
76Actual
Phase
Phase 2
Conditions
Allergy, Peanut
Interventions
LOU064
placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05432388
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CLOU064I12201
Secondary IDs
ID
Type
Description
Link
2021-006950-30
EudraCT Number
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
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 12, 2022Actual
Primary Completion Date
Mar 11, 2025Actual
Completion Date
Mar 11, 2025Actual
First Submitted Date
May 31, 2022
First Submission Date that Met QC Criteria
Jun 20, 2022
First Posted Date
Jun 27, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Mar 2, 2026
Results First Submitted that Met QC Criteria
May 18, 2026
Results First Posted Date
Jun 12, 2026Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 18, 2026
Last Update Posted Date
Jun 12, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 was 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 was a randomized, participant- and investigator-blinded, placebo-controlled study to assess the safety and clinical efficacy of oral LOU064 versus placebo across five treatment arms in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy for one-month treatment period (up to 5 weeks). Participants had 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.
Conditions Module
Conditions
Allergy, Peanut
Keywords
Groundnut Hypersensitivity
Hypersensitivity, Peanut
Peanut Allergy
Food Allergy
Oral food challenge
IgE
Remibrutinib
BTKi
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
76Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LOU064 10 mg
Experimental
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
Drug: LOU064
LOU064 25 mg
Experimental
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
Drug: LOU064
LOU064 100 mg
Experimental
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Drug: LOU064
Placebo + LOU064 25 mg
Experimental
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
Drug: LOU064
Drug: placebo
Placebo
Placebo Comparator
Placebo was administered orally twice per day, on Days 1 through 28.
Drug: placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LOU064
Drug
oral tablets
LOU064 10 mg
LOU064 100 mg
LOU064 25 mg
Placebo + LOU064 25 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Week 4
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Allervie Clinical Research
Birmingham
Alabama
35209
United States
Arkansas Children's Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
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.
The study consisted of a screening period of approximately 4 weeks.
Recruitment Details
Participants took part in 22 investigative sites in United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
FG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 9, 2024
Mar 2, 2026
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Spain
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
remibrutinib
placebo
Drug
oral tablets
Placebo
Placebo + LOU064 25 mg
Week 4
Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Week 4
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Week 4
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 3000 mg during the DBPCFC conducted at one month, will be categorized as 4 levels: None, Mild, Moderate, Severe.
4 weeks
Change From Baseline of Peanut-specific IgE (Including Peanut Components)
IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)
IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Baseline, Day 25 pre-dose and Day 31 (End of Study)
Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters
An allergen specific skin prick test (SPT) is a commonly used diagnostic tool. In this study a titration SPT using peanut allergen provided additional information on the impact of Bruton's tyrosine kinase (BTK) suppression on skin mast cells. Skin reactions were recorded after 15 minutes of applying allergen to the pricked location. The size of the wheel and flare (the longest diameter and the midpoint orthogonal diameter) at each site were recorded.
Baseline, Day 26
Maximum Observed Blood Concentration (Cmax) of LOU064
Cmax is the maximum (peak) observed blood concentration of LOU064 after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Blood Concentration-time Curve (AUClast) of LOU064
AUClast is the area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LOU064. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064
AUCtau is the area under the plasma concentration-time curve. Estimation of AUCtau values required extrapolation of the concentration-time profile from the last measured time-point at 4 h to the end of dosing interval at 12 h post-dose. In some cases, this extrapolation was not possible. For this reason, the number of participants with measurable AUCtau values was less when compared to those with AUClast. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064
Tmax is the time to reach maximum (peak) of LOU064 blood concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
4 weeks
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
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
CR Services Acquisition US Main center
Columbus
Ohio
43213
United States
CR Services Acquisition US
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
FG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
FG003
Placebo + LOU064 25 mg
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
FG004
Placebo
Placebo was administered orally twice per day, on Days 1 through 28.
FG00019 subjects
FG00119 subjects
FG00218 subjects
FG00310 subjects
FG00410 subjects
Pharmacodynamic (PD) Analysis Set
The PD analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.
FG00019 subjects
FG00117 subjects
FG00217 subjects
FG0037 subjects
FG0049 subjects
COMPLETED
FG00015 subjects
FG00118 subjects
FG00216 subjects
FG0039 subjects
FG0048 subjects
NOT COMPLETED
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
Type
Comment
Reasons
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Protocol Deviation
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Technical Problems
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
BG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
BG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
BG003
Placebo + LOU064 25 mg
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
BG004
Placebo
Placebo was administered orally twice per day, on Days 1 through 28.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00019
BG00119
BG00218
BG00310
BG00410
BG00576
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00024.8± 7.41
BG00127.8± 9.93
BG00223.6± 3.33
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0015
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00013
BG00115
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Participants in the pharmacodynamic (PD) analysis set from the arms ¨LOU064 10 mg¨, ¨LOU064 25 mg¨, ¨LOU064 100 mg¨ and ¨Placebo¨ who had an available value and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
OG003
Placebo
Placebo was administered orally twice per day, on Days 1 through 28.
Units
Counts
Participants
OG00015
OG00116
OG00215
OG003
Title
Denominators
Categories
Title
Measurements
OG00040.0
OG00150.0
OG00286.7
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Bayesian Analysis
Difference in Marginal Response Rate
0.34
2-Sided
80
0.17
0.51
Other
Bayesian logistic regression model
OG000
OG003
Bayesian Analysis
Secondary
Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 1000 mg (2044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo
Responder rate was defined as the percentage of participants tolerating a single dose of >= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Participants in the pharmacodynamic (PD) analysis set from the arms ¨Placebo+LOU064 25 mg¨ and ¨Placebo¨ who had an available value and no logistic/assay/analytical issues that impacted the PD data. Participants who had missing DBPCFC outcomes at the end of the treatment period (attributed to scheduling conflicts or reasons related to LOU064 intake) were considered missing at random and ignored in the calculation of responder rate.
Posted
Number
percentage of participants
Week 4
ID
Title
Description
OG000
Placebo + LOU064 25 mg
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
OG001
Placebo
Secondary
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC
Maximum severity of symptoms occurring at any challenge dose of peanut protein up to and including 3000 mg during the DBPCFC conducted at one month, will be categorized as 4 levels: None, Mild, Moderate, Severe.
Participants in the pharmacodynamic (PD) analysis set with an available value for the outcome measure. The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.
Posted
Number
participants
4 weeks
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
OG003
Placebo + LOU064 25 mg
Secondary
Change From Baseline of Peanut-specific IgE (Including Peanut Components)
IgE is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Participants in the pharmacodynamic (PD) analysis set with an available value for the outcome measure. The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.
The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.
Posted
Median
Full Range
kU/L
Baseline, Day 25 pre-dose and Day 31 (End of Study)
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
OG003
Placebo + LOU064 25 mg
Secondary
Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)
IgG4 is a soluble biomarker that provide LOU064 response to treatment and disease severity biomarkers.
Participants in the pharmacodynamic (PD) analysis set with an available value for the outcome measure. The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.
The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.
Posted
Median
Full Range
mg/L
Baseline, Day 25 pre-dose and Day 31 (End of Study)
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
OG003
Placebo + LOU064 25 mg
Secondary
Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters
An allergen specific skin prick test (SPT) is a commonly used diagnostic tool. In this study a titration SPT using peanut allergen provided additional information on the impact of Bruton's tyrosine kinase (BTK) suppression on skin mast cells. Skin reactions were recorded after 15 minutes of applying allergen to the pricked location. The size of the wheel and flare (the longest diameter and the midpoint orthogonal diameter) at each site were recorded.
Participants in the pharmacodynamic (PD) analysis set with an available value for the outcome measure. The pharmacodynamic (PD) analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.
Posted
Mean
Standard Deviation
mm
Baseline, Day 26
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Maximum Observed Blood Concentration (Cmax) of LOU064
Cmax is the maximum (peak) observed blood concentration of LOU064 after dose administration. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
The PK analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received LOU064 and had no protocol deviations that impacted the PK data. The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.
Posted
Mean
Standard Deviation
ng/mL
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Area Under Blood Concentration-time Curve (AUClast) of LOU064
AUClast is the area under the blood concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of LOU064. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
The PK analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received LOU064 and had no protocol deviations that impacted the PK data. The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.
Posted
Mean
Standard Deviation
h*ng/mL
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Area Under Plasma Concentration-time Curve (AUCtau) of LOU064
AUCtau is the area under the plasma concentration-time curve. Estimation of AUCtau values required extrapolation of the concentration-time profile from the last measured time-point at 4 h to the end of dosing interval at 12 h post-dose. In some cases, this extrapolation was not possible. For this reason, the number of participants with measurable AUCtau values was less when compared to those with AUClast. Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
The PK analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received LOU064 and had no protocol deviations that impacted the PK data. The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.
Posted
Mean
Standard Deviation
h*ng/mL
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064
Tmax is the time to reach maximum (peak) of LOU064 blood concentration after single-dose administration (time). Pharmacokinetic parameters were calculated using a non-compartmental method (WinNonLin Version 8.3.4 or higher). The LOU064 concentration was determined by a validated Liquid chromatography-mass spectrometry (LC-MS/MS) method with a lower limit of quantification (LLOQ) of 0.1 ng/mL.
The PK analysis set included all participants with at least one available valid (i.e., not flagged for exclusion) PK concentration measurement, who received LOU064 and had no protocol deviations that impacted the PK data. The participants analyzed in each row include only those with an available value for the outcome measure at the corresponding visit.
Posted
Median
Full Range
hours
Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
Secondary
Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC
Responder rate was defined as the percentage of participants tolerating a single dose of >= 3000 mg (5044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
Participants in the pharmacodynamic (PD) analysis set with available values for the outcome measure. The PD analysis set included all participants with available PD data and no logistic/assay/analytical issues that impacted the PD data.
Posted
Count of Participants
Participants
4 weeks
ID
Title
Description
OG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
OG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
OG002
Time Frame
Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 58 days.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
0
19
0
19
10
19
EG001
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
0
19
0
19
8
19
EG002
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
0
18
0
18
6
18
EG003
Placebo + LOU064 25 mg (Placebo Period)
Placebo was administered orally twice per day, on Days 1 through 21.
0
10
0
10
2
10
EG004
Placebo + LOU064 25 mg (LOU064 Period)
LOU064 25 mg twice per day, on Days 22 through 28.
0
10
0
10
5
10
EG005
Placebo
Placebo was administered orally twice per day, on Days 1 through 28.
0
10
0
10
8
10
EG006
Total
Total
0
76
0
76
38
76
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0062 affected76 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Fatigue
General disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Pyrexia
General disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Body tinea
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
COVID-19
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Ear infection
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0012 affected19 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0011 affected19 at risk
EG0021 affected18 at risk
EG003
Viral infection
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Wrong dose
Injury, poisoning and procedural complications
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Sucrose intolerance
Metabolism and nutrition disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Brain fog
Nervous system disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0012 affected19 at risk
EG0020 affected18 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Childhood asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0010 affected19 at risk
EG0021 affected18 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (28.0)
Systematic Assessment
EG0000 affected19 at risk
EG0011 affected19 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA (28.0)
Systematic Assessment
EG0001 affected19 at risk
EG0010 affected19 at risk
EG0020 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.