Study in Pediatric Subjects With Peanut Allergy to Evalua... | NCT03682770 | Trialant
NCT03682770
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
Feb 7, 2024Actual
Enrollment
148Actual
Phase
Phase 2
Conditions
Peanut Allergy
Interventions
Dupilumab
Placebo matching dupilumab
AR101
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03682770
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R668-ALG-16114
Secondary IDs
Not provided
Brief Title
Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Official Title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study in Pediatric Subjects With Peanut Allergy to Evaluate the Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Jan 2024
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 3, 2018Actual
Primary Completion Date
Oct 16, 2020Actual
Completion Date
Jul 23, 2021Actual
First Submitted Date
Sep 21, 2018
First Submission Date that Met QC Criteria
Sep 21, 2018
First Posted Date
Sep 25, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 13, 2023
Results First Submitted that Met QC Criteria
Jan 12, 2024
Results First Posted Date
Feb 7, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 14, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Feb 7, 2024Actual
Last Update Submitted Date
Jan 12, 2024
Last Update Posted Date
Feb 7, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Sanofi
INDUSTRY
Aimmune Therapeutics, Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Primary objective is to assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the proportion of participants who pass a post up-dosing double-blind placebo-controlled food challenge (DBPCFC) at visit 16.
Secondary objectives are:
To assess whether dupilumab as adjunct to AR101 compared to placebo improves desensitization at the completion of up-dosing, defined as an increase in the cumulative tolerated dose (log transformed) of peanut protein during a post up-dosing DBPCFC at visit 16
To assess whether dupilumab as (indefinite [continuously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22
To assess whether dupilumab as (limited [previously]) adjunct to AR101 compared to placebo maintains desensitization, defined as an increase in the proportion of participants who pass a post maintenance DBPCFC at visit 22
To evaluate the safety and tolerability of dupilumab as adjunct to AR101 compared to placebo
To assess the effect of dupilumab (compared to placebo) as adjunct to AR101 on the change in peanut-specific Immunoglobulin E (sIgE), Immunoglobulin G (IgG), Immunoglobulin G4 (IgG4), and peanut-specific IgG4/IgE ratio
To assess if dupilumab increases the tolerability of AR101 as measured by the daily symptoms (electronic diary [e-diary]) during the up-dosing phase
Detailed Description
Not provided
Conditions Module
Conditions
Peanut Allergy
Keywords
Not provided
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
148Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
dupilumab + AR101
Experimental
Participant randomization of a ratio of 2 active dupilumab arms
Drug: Dupilumab
Drug: AR101
placebo matching dupilumab + AR101
Experimental
Participant randomization of a ratio of 1 placebo arm
Drug: Placebo matching dupilumab
Drug: AR101
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dupilumab
Drug
Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)
dupilumab + AR101
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Passed a Post Up-dosing Double-blind, Placebo-controlled Food Challenge (DBPCFC) With 2044 mg (Cumulative) Peanut Protein at Visit 16 (Week 28 to 40)
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab plus AR101 vs placebo plus AR101 who passed a post up-dosing DBPCFC with 2044 mg (Cumulative) peanut protein at Visit 16 (Week 28 to 40) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
At Visit 16 (Week 28 to 40)
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 16 (Week 28 to 40) in Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Visit 16 (Week 28 to 40) in participants treated with dupilumab plus AR101 vs placebo plus AR101 was reported. Cumulative tolerated dose during the specified period was calculated as the mean of all available post-randomization values during the specified time period (Week 28 to Week 40).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Experience dose-limiting symptoms at or before the challenge dose of peanut protein on screening and not experiencing dose-limiting symptoms to placebo as defined in the protocol
Serum Immunoglobulin E (IgE) to peanut of ≥10 kUA/L and/or a skin prick test (SPT) to peanut ≥8 mm compared to a negative control
Participants/legal guardians must be trained on the proper use of the epinephrine autoinjector device to be allowed to enroll in the study
Participants with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study
Key Exclusion Criteria:
History of other chronic disease (other than asthma, Atopic Dermatitis (AD), or allergic rhinitis) requiring therapy (eg, heart disease, diabetes, hypertension) that would represent a risk to participant's health or safety in this study or ability to comply with study protocol
History of frequent or recent severe, life-threatening episode of anaphylaxis or anaphylactic shock
History of eosinophilic Gastrointestinal (GI) disease
Asthma at time of enrollment with any of the following:
Forced Expiratory Volume 1 Second (FEV1) <80% of predicted or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted with or without controller medications
Inhaled corticosteroids (ICS) dosing of daily fluticasone (or equivalent ICS based on NHLBI dosing chart)
One hospitalization in the past year for asthma
Emergency room visit for asthma within 6 months prior to screening
Use of systemic corticosteroids within 2 months prior to screening
Use of other forms of allergen immunotherapy or immunomodulatory therapy within 3 months prior to screening
Use of any agents known or likely to interact with epinephrine (eg, beta-blockers, angiotensin converting enzyme-inhibitors, tri-cyclic antidepressants, or other drugs), within 3 weeks prior to screening
Allergy to oat (placebo in DBPCFC)
Note: Other protocol Inclusion/Exclusion Criteria apply
Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 232 participants were screened; 148 participants were randomized. Of the 84 not randomized, 53 did not meet inclusion/exclusion criteria and 13 withdrew consent.
Participants of ≥60 kilograms (kg) body weight (BW) received dupilumab 300 milligrams (mg) subcutaneously (SC) every 2 weeks (Q2W); participants of ≥ 30kg to < 60kg BW received dupilumab 200 mg SC Q2W; participants of <30kg BW received dupilumab 100 mg SC Q2W
Placebo matching dupilumab is prepared in the same formulation without the addition of protein
placebo matching dupilumab + AR101
AR101
Drug
AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
dupilumab + AR101
placebo matching dupilumab + AR101
Baseline, Visit 16 (Week 28 to 40)
Percentage of Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Reached the 300 mg/Day Dose of AR101 by Visit 16 (Week 28 to 40)
Percentage of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reached the 300 mg/day dose of AR101 by Visit 16 (Week 28 to 40) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
At Visit 16 (Week 28 to 40)
Time From Randomization to the First Time When Participants Reached the 300 mg/Day Dose of AR101 During the Up-dosing Treatment Phase by Visit 16 (Week 28 to 40)
Time (in days) from randomization to the first time when participants reached the 300 mg/day dose of AR101 during the up-dosing treatment phase by Visit 16 (Week 28 to 40) was reported. If participants did not reach the 300 mg/day dose of AR101 during the 28-week treatment period, they were censored at the date of their last visit during pre-AR101 dosing and AR101 up-dosing treatment period. Analysis was performed using Kaplan-Meier Estimated method.
At Visit 16 (Week 28 to 40)
Percentage of Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Passed a Post Maintenance DBPCFC With 2044 mg (Cumulative) Peanut Protein at Visit 22 (Week 52 to 64)
Symptoms considered to be allergic were graded using the CoFAR Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 who passed a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein at Visit 22 (Week 52 to 64) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 52 to Week 64).
At Visit 22 (Week 52 to 64)
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 22 (Week 52 to 64) in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Visit 22 (Week 52 to 64) in participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 was reported. Cumulative tolerated dose during the specified period was calculated as the mean of all available post-randomization values during the specified time period (Week 52 to Week 64).
Baseline, Visit 22 (Week 52 to 64)
Percentage of Participants (Previously) Treated With Dupilumab + AR101/Placebo +AR101 vs Placebo Plus AR101 Who Passed a Post Maintenance DBPCFC With 2044 mg (Cumulative) Peanut Protein at Visit 22 (Week 52 to 64)
Symptoms considered to be allergic were graded using the CoFAR Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 who "pass" a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein at Visit 22 (Week 52 to 64) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 52 to Week 64).
At Visit 22 (Week 52 to 64)
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 22 (Week 52 to 64) in Participants (Previously) Treated With Dupilumab + AR101/Placebo +AR101 vs Placebo Plus AR101
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Visit 22 (Week 52 to 64) in participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 was reported. Cumulative tolerated dose during the specified period was calculated as the mean of all available post-randomization values during the specified time period (Week 52 to Week 64).
Baseline, Visit 22 (Week 52 to 64)
Percent Change From Baseline in Peanut-specific IgE in Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 to Visit 16 (Week 28 to 40)
Percent change from baseline in peanut-specific IgE in participants treated with dupilumab + AR101 vs placebo + AR101 to Visit 16 (Week 28 to 40) was reported. Analysis was performed using Last observation carried forward (LOCF) method. Data reported during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
Baseline up to Visit 16 (Weeks 28 to 40)
Percent Change From Baseline in Peanut-specific IgE in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 to Visit 22 (Week 52 to 64)
Percent change from baseline in peanut-specific IgE in participants treated with dupilumab + AR101 vs placebo + AR101 to Visit 22 (Week 52 to 64) was reported. Analysis was performed using LOCF method. Data reported during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 52 to Week 64).
Baseline up to Visit 22 (Week 52 to 64)
Percent Change From Baseline in Peanut-specific IgE in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 to Visit 25 (Weeks 64 to 76)
Percent change from baseline in peanut-specific IgE in participants treated with dupilumab + AR101 vs placebo + AR101 to Visit 25 (Week 64 to 76) was reported. Analysis was performed using LOCF method. Data reported during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 64 to Week 76).
Baseline up to Visit 25 (Weeks 64 to 76)
Tucson
Arizona
85724
United States
Regeneron Investigational Site
Little Rock
Arkansas
72202
United States
Regeneron Investigational Site
Los Angeles
California
90027
United States
Regeneron Investigational Site
Los Angeles
California
90095
United States
Regeneron Investigational Site
Mission Viejo
California
92691
United States
Regeneron Investigational Site
Mountain View
California
94040
United States
Regeneron Investigational Site
Rolling Hills Estates
California
90274
United States
Regeneron Investigational Site
Denver
Colorado
80206
United States
Regeneron Investigational Site
Washington D.C.
District of Columbia
20010
United States
Regeneron Investigational Site
Tampa
Florida
33612
United States
Regeneron Investigational Site
Atlanta
Georgia
30329
United States
Regeneron Investigational Site
Marietta
Georgia
30144
United States
Regeneron Investigational Site
Chicago
Illinois
60611
United States
Regeneron Investigational Site
Baltimore
Maryland
21287
United States
Regeneron Investigational Site
Boston
Massachusetts
02114
United States
Regeneron Investigational Site
Ann Arbor
Michigan
48106
United States
Regeneron Investigational Site
Ypsilanti
Michigan
48197
United States
Regeneron Investigational Site
Minneapolis
Minnesota
55402
United States
Regeneron Investigational Site
Ocean Township
New Jersey
07712
United States
Regeneron Investigational Site
Great Neck
New York
11021
United States
Regeneron Investigational Site
New York
New York
10029
United States
Regeneron Investigational Site
Chapel Hill
North Carolina
27599
United States
Regeneron Investigational Site
Philadelphia
Pennsylvania
19104
United States
Regeneron Investigational Site
Seattle
Washington
98115
United States
FG002
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
FG003
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
FG004
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
FG005
AR101 Maintenance Period: Dupilumab + AR101 Continued
Participants who received dupilumab + AR101 in up-dosing period continued to receive dupilumab + AR101 in the maintenance period
Participants who received dupilumab + AR101 in the up-dosing period switched to placebo-matched dupilumab + AR101 in the maintenance period
FG00050 subjects
FG00198 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
Completed = Progressed to Up-dosing period
FG00049 subjects
FG00196 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Sponsor decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
AR101 Up-dosing Period (Week 28-40)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG00249 subjects
FG00396 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
Completed = Progressed to Maintenance period
FG0000 subjects
FG0010 subjects
FG00239 subjects
FG00388 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00210 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG003
AR101 Maintenance Period: (Week 52-64)
Type
Comment
Milestone Data
STARTED
Randomized
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00440 subjectsParticipants who completed and ongoing in Up-dosing Period: placebo + AR101 were randomized into the AR101 maintenance period. One additional participant was randomized and received treatment in placebo + AR101 group in AR101 maintenance period.
FG00544 subjectsParticipants who completed and ongoing in Up-dosing Period: dupilumab + AR101 were re-randomized (1:1) ratio into the AR101 maintenance period.
FG00644 subjectsParticipants who completed and ongoing in Up-dosing Period: dupilumab + AR101 were re-randomized (1:1) ratio into the AR101 maintenance period.
Randomized and Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Full analysis set (FAS) included all randomized participants
Participants of ≥60 kilograms (kg) body weight (BW) received dupilumab 300 milligrams (mg) subcutaneously (SC) every 2 weeks (Q2W); participants of ≥ 30kg to < 60kg BW received dupilumab 200 mg SC Q2W; participants of <30kg BW received dupilumab 100 mg SC Q2W
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00050
BG00198
BG002148
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
BG00010.9± 3.00
BG00111.3± 3.12
BG00211.1± 3.08
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG00138
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0018
BG002
Race/Ethnicity, Customized
Race
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00040
BG00170
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 Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Passed a Post Up-dosing Double-blind, Placebo-controlled Food Challenge (DBPCFC) With 2044 mg (Cumulative) Peanut Protein at Visit 16 (Week 28 to 40)
Symptoms considered to be allergic were graded using the Consortium of Food Allergy Research (CoFAR) Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants treated with dupilumab plus AR101 vs placebo plus AR101 who passed a post up-dosing DBPCFC with 2044 mg (Cumulative) peanut protein at Visit 16 (Week 28 to 40) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
Modified full analysis set (mFAS) included all participants in the full analysis set (FAS) who underwent biweekly in-clinic up-dosing as described/specified in the protocol and underwent the post up-dosing DBPCFC at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Up-dosing Period: Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Number
95% Confidence Interval
Percentage of participants
At Visit 16 (Week 28 to 40)
ID
Title
Description
OG000
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
OG001
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
Units
Counts
Participants
OG00039
OG00184
Title
Denominators
Categories
Title
Measurements
OG00035.90(21.204 to 52.820)
OG00155.95(44.695 to 66.778)
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
OG001
Cochran-Mantel-Haenszel
0.0420
The p-value was derived by Cochran-Mantel-Haenszel (CMH) test stratified by screening peanut-specific IgE level and baseline body weight.
Difference in percentage
20.23
2-Sided
95
1.266
39.189
Difference in percentage derived by Mantel-Haenszel (MH) method
Superiority
Secondary
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 16 (Week 28 to 40) in Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Visit 16 (Week 28 to 40) in participants treated with dupilumab plus AR101 vs placebo plus AR101 was reported. Cumulative tolerated dose during the specified period was calculated as the mean of all available post-randomization values during the specified time period (Week 28 to Week 40).
mFAS included all participants in the FAS who underwent biweekly in-clinic up-dosing as described/specified in the protocol and underwent the post up-dosing DBPCFC at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Up-dosing Period: Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Least Squares Mean
Standard Error
Log Transformed Milligrams
Baseline, Visit 16 (Week 28 to 40)
ID
Title
Description
OG000
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
OG001
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
Secondary
Percentage of Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Reached the 300 mg/Day Dose of AR101 by Visit 16 (Week 28 to 40)
Percentage of participants treated with dupilumab plus AR101 vs placebo plus AR101 who reached the 300 mg/day dose of AR101 by Visit 16 (Week 28 to 40) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
mFAS included all participants in the FAS who underwent biweekly in-clinic up-dosing as described/specified in the protocol and underwent the post up-dosing DBPCFC at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Up-dosing Period: Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Number
95% Confidence Interval
Percentage of participants
At Visit 16 (Week 28 to 40)
ID
Title
Description
OG000
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
OG001
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
Secondary
Time From Randomization to the First Time When Participants Reached the 300 mg/Day Dose of AR101 During the Up-dosing Treatment Phase by Visit 16 (Week 28 to 40)
Time (in days) from randomization to the first time when participants reached the 300 mg/day dose of AR101 during the up-dosing treatment phase by Visit 16 (Week 28 to 40) was reported. If participants did not reach the 300 mg/day dose of AR101 during the 28-week treatment period, they were censored at the date of their last visit during pre-AR101 dosing and AR101 up-dosing treatment period. Analysis was performed using Kaplan-Meier Estimated method.
mFAS included all participants in the FAS who underwent biweekly in-clinic up-dosing as described/specified in the protocol and underwent the post up-dosing DBPCFC at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Up-dosing Period: Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Mean
Standard Deviation
Days
At Visit 16 (Week 28 to 40)
ID
Title
Description
OG000
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
OG001
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
Secondary
Percentage of Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 Who Passed a Post Maintenance DBPCFC With 2044 mg (Cumulative) Peanut Protein at Visit 22 (Week 52 to 64)
Symptoms considered to be allergic were graded using the CoFAR Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 who passed a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein at Visit 22 (Week 52 to 64) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 52 to Week 64).
FAS-maintenance (a subset of FAS) included participants in the FAS who achieved 300 mg/day AR101 for at least 2 weeks in the up-dosing phase and re-randomized based on the treatment allocated by the IWRS at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Maintenance Period: Continuously on Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Number
95% Confidence Interval
Percentage of participants
At Visit 22 (Week 52 to 64)
ID
Title
Description
OG000
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
Secondary
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 22 (Week 52 to 64) in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Visit 22 (Week 52 to 64) in participants (continuously) treated with dupilumab plus AR101 vs placebo plus AR101 was reported. Cumulative tolerated dose during the specified period was calculated as the mean of all available post-randomization values during the specified time period (Week 52 to Week 64).
FAS-maintenance (a subset of FAS) included participants in the FAS who achieved 300 mg/day AR101 for at least 2 weeks in the up-dosing phase and re-randomized based on the treatment allocated by the IWRS at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Maintenance Period: Continuously on Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Least Squares Mean
Standard Error
Log Transformed Milligrams
Baseline, Visit 22 (Week 52 to 64)
ID
Title
Description
OG000
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
OG001
AR101 Maintenance Period: Dupilumab + AR101 Continued
Participants who received dupilumab + AR101 in up-dosing period continued to receive dupilumab + AR101 in the maintenance period
Secondary
Percentage of Participants (Previously) Treated With Dupilumab + AR101/Placebo +AR101 vs Placebo Plus AR101 Who Passed a Post Maintenance DBPCFC With 2044 mg (Cumulative) Peanut Protein at Visit 22 (Week 52 to 64)
Symptoms considered to be allergic were graded using the CoFAR Grading Scale for Systemic Allergic Reactions. The allergic reaction is measured on a 1-5 scale, with grade 1 being mild, grade 2 being moderate, grade 3 being severe, grade 4 being life threatening, and grade 5 as death. the higher the grade, the more severe the allergic reaction. Participants were considered to have passed the DBPCFC if they did not experience any objective Grade 1 reaction. Percentage of participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 who "pass" a post maintenance DBPCFC with 2044 mg (cumulative) peanut protein at Visit 22 (Week 52 to 64) was reported. Cumulative data during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 52 to Week 64).
FAS-maintenance (a subset of FAS) included participants in the FAS who achieved 300 mg/day AR101 for at least 2 weeks in the up-dosing phase and re-randomized based on the treatment allocated by the IWRS at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Maintenance Period: Dupilumab + AR101/Placebo +AR101 vs Placebo + AR101.
Posted
Number
95% Confidence Interval
Percentage of participants
At Visit 22 (Week 52 to 64)
ID
Title
Description
OG000
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
Secondary
Change From Baseline in Cumulative Tolerated Dose (Log Transformed) of Peanut Protein During a DBPCFC at Visit 22 (Week 52 to 64) in Participants (Previously) Treated With Dupilumab + AR101/Placebo +AR101 vs Placebo Plus AR101
Change from baseline in cumulative tolerated dose (log transformed) of peanut protein during a DBPCFC at Visit 22 (Week 52 to 64) in participants (previously) treated with dupilumab plus AR101 (and re-randomized to placebo plus AR101) vs placebo plus AR101 was reported. Cumulative tolerated dose during the specified period was calculated as the mean of all available post-randomization values during the specified time period (Week 52 to Week 64).
FAS-maintenance (a subset of FAS) included participants in the FAS who achieved 300 mg/day AR101 for at least 2 weeks in the up-dosing phase and re-randomized based on the treatment allocated by the IWRS at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Maintenance Period: Dupilumab + AR101/Placebo +AR101 vs Placebo + AR101.
Posted
Least Squares Mean
Standard Error
Log Transformed Milligrams
Baseline, Visit 22 (Week 52 to 64)
ID
Title
Description
OG000
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
Percent Change From Baseline in Peanut-specific IgE in Participants Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 to Visit 16 (Week 28 to 40)
Percent change from baseline in peanut-specific IgE in participants treated with dupilumab + AR101 vs placebo + AR101 to Visit 16 (Week 28 to 40) was reported. Analysis was performed using Last observation carried forward (LOCF) method. Data reported during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 28 to Week 40).
mFAS included all participants in the FAS who underwent biweekly in-clinic up-dosing as described/specified in the protocol and underwent the post up-dosing DBPCFC at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Up-dosing Period: Dupilumab plus AR101 vs Placebo plus AR101.
Posted
Median
Inter-Quartile Range
Percent change
Baseline up to Visit 16 (Weeks 28 to 40)
ID
Title
Description
OG000
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
OG001
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
Secondary
Percent Change From Baseline in Peanut-specific IgE in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 to Visit 22 (Week 52 to 64)
Percent change from baseline in peanut-specific IgE in participants treated with dupilumab + AR101 vs placebo + AR101 to Visit 22 (Week 52 to 64) was reported. Analysis was performed using LOCF method. Data reported during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 52 to Week 64).
mFAS-maintenance (a subset of mFAS) included participants in the mFAS who achieved 300 mg/day AR101 for at-least 2 weeks in the up-dosing phase and re-randomized based on the treatment allocated by the IWRS at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Maintenance Period: Continuously on Dupilumab Plus AR101 vs Placebo Plus AR101.
Posted
Median
Full Range
Percent change
Baseline up to Visit 22 (Week 52 to 64)
ID
Title
Description
OG000
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
OG001
AR101 Maintenance Period: Dupilumab + AR101 Continued
Participants who received dupilumab + AR101 in up-dosing period continued to receive dupilumab + AR101 in the maintenance period
Secondary
Percent Change From Baseline in Peanut-specific IgE in Participants (Continuously) Treated With Dupilumab Plus AR101 vs Placebo Plus AR101 to Visit 25 (Weeks 64 to 76)
Percent change from baseline in peanut-specific IgE in participants treated with dupilumab + AR101 vs placebo + AR101 to Visit 25 (Week 64 to 76) was reported. Analysis was performed using LOCF method. Data reported during the specified period was calculated as the average of all available post-randomization values during the specified time period (Week 64 to Week 76).
mFAS-maintenance (a subset of mFAS) included participants in the mFAS who achieved 300 mg/day AR101 for at-least 2 weeks in the up-dosing phase and re-randomized based on the treatment allocated by the IWRS at Visit 16 (Weeks 28 to 40). Data were planned to be reported and analyzed only for AR101 Maintenance Period: Continuously on Dupilumab Plus AR101 vs Placebo Plus AR101.
Posted
Median
Full Range
Percent change
Baseline up to Visit 25 (Weeks 64 to 76)
ID
Title
Description
OG000
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
OG001
AR101 Maintenance Period: Dupilumab + AR101 Continued
Participants who received dupilumab + AR101 in up-dosing period continued to receive dupilumab + AR101 in the maintenance period
Participants of ≥60 kilograms (kg) body weight (BW) received dupilumab 300 milligrams (mg) subcutaneously (SC) every 2 weeks (Q2W); participants of ≥ 30kg to < 60kg BW received dupilumab 200 mg SC Q2W; participants of <30kg BW received dupilumab 100 mg SC Q2W
0
98
0
98
23
98
EG002
AR101 Up-dosing Period: Placebo + AR101
Participants who received placebo-matched dupilumab in the pre-AR101 dosing period received placebo in combination with a gradual up-dosing of AR101 oral capsules
0
49
0
49
34
49
EG003
AR101 Up-dosing Period: Dupilumab + AR101
Participants who received dupilumab in the pre-AR101 dosing period received dupilumab during the up-dosing period in combination with a gradual up-dosing of AR101 oral capsules
0
96
0
96
47
96
EG004
AR101 Maintenance Period: Placebo-matched Dupilumab + AR101 Continued
Participants who received placebo-matched dupilumab + AR101 in the up-dosing period continued in the maintenance period
0
40
0
40
13
40
EG005
AR101 Maintenance Period: Dupilumab + AR101 Continued
Participants who received dupilumab + AR101 in up-dosing period continued to receive dupilumab + AR101 in the maintenance period
Participants who received dupilumab + AR101 in the up-dosing period switched to placebo-matched dupilumab + AR101 in the maintenance period
0
43
0
43
15
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected49 at risk
EG0030 events0 affected96 at risk
EG0040 events0 affected40 at risk
EG0051 events1 affected42 at risk
EG0060 events0 affected43 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0005 events5 affected50 at risk
EG0012 events2 affected98 at risk
EG0029 events7 affected49 at risk
EG00321 events16 affected96 at risk
EG004
Viral infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0023 events3 affected49 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected50 at risk
EG0012 events2 affected98 at risk
EG0020 events0 affected49 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected98 at risk
EG0023 events3 affected49 at risk
EG003
Otitis media
Infections and infestations
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0023 events3 affected49 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG00210 events5 affected49 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0012 events1 affected98 at risk
EG0025 events2 affected49 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0027 events3 affected49 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0012 events2 affected98 at risk
EG00211 events8 affected49 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0026 events5 affected49 at risk
EG003
Oral pruritus
Gastrointestinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0024 events3 affected49 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected98 at risk
EG0023 events3 affected49 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0026 events5 affected49 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected98 at risk
EG0027 events4 affected49 at risk
EG003
Injection site reaction
General disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0019 events5 affected98 at risk
EG00213 events3 affected49 at risk
EG003
Injection site urticaria
General disorders
MedDRA (24.0)
Systematic Assessment
EG0002 events2 affected50 at risk
EG0017 events5 affected98 at risk
EG0029 events2 affected49 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0022 events2 affected49 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0022 events2 affected49 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0024 events4 affected49 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected50 at risk
EG0013 events2 affected98 at risk
EG0028 events4 affected49 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected49 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected98 at risk
EG0023 events3 affected49 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0022 events2 affected49 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0026 events3 affected49 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected49 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0010 events0 affected98 at risk
EG0022 events1 affected49 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (24.0)
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected98 at risk
EG0020 events0 affected49 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 investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
P-value is based on treatment difference (dupilumab + AR101 vs placebo + AR101) of the LS mean change using analysis of covariance (ANCOVA) model.
Least Square Mean Difference
0.67
2-Sided
95
0.031
1.305
Superiority
Units
Counts
Participants
OG00039
OG00184
Title
Denominators
Categories
Title
Measurements
OG00076.92(60.674 to 88.866)
OG00189.29(80.633 to 94.982)
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
OG001
Cochran-Mantel-Haenszel
0.0806
P-values were derived by CMH test stratified by screening peanut-specific IgE level (<=100 kilo allergy unit per liter [kUA/L] vs >100 kUA/L) and body weight (<30 kg, >=30 and <60 kg, or >=60 kg).
Difference in percentage
11.91
2-Sided
95
-3.612
27.440
Difference in percentage derived by MH method
Superiority
Units
Counts
Participants
OG00039
OG00184
Title
Denominators
Categories
Title
Measurements
OG000164.6± 38.43
OG001167.5± 32.01
OG001
AR101 Maintenance Period: Dupilumab + AR101 Continued
Participants who received dupilumab + AR101 in up-dosing period continued to receive dupilumab + AR101 in the maintenance period
Units
Counts
Participants
OG00040
OG00144
Title
Denominators
Categories
Title
Measurements
OG00047.50(31.512 to 63.872)
OG00156.82(41.034 to 71.651)
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
OG001
Cochran-Mantel-Haenszel
0.3530
P-values were derived by CMH test stratified by screening peanut-specific IgE level (<=100 kUA/L vs >100 kUA/L) and baseline body weight (<30 kg, >=30 kg and <60 kg, or >=60 kg).
Difference in percentage
10.40
2-Sided
95
-11.668
32.474
Difference in percentage derived by MH method
Superiority
Units
Counts
Participants
OG00040
OG00144
Title
Denominators
Categories
Title
Measurements
OG0004.19± 0.245
OG0014.56± 0.250
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
OG001
ANCOVA
0.2628
P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.
Participants who received dupilumab + AR101 in the up-dosing period switched to placebo-matched dupilumab + AR101 in the maintenance period
Units
Counts
Participants
OG00040
OG00144
Title
Denominators
Categories
Title
Measurements
OG00047.50(31.512 to 63.872)
OG00145.45(30.391 to 61.153)
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
OG001
Cochran-Mantel-Haenszel
0.8140
P-values were derived by CMH test stratified by screening peanut-specific IgE level (<=100 kUA/L vs >100 kUA/L) and baseline body weight (<30 kg, >=30 kg and <60 kg, or >=60 kg).
Difference in percentage
-2.36
2-Sided
95
-25.004
20.282
Difference in percentage derived by MH method
Superiority
Participants who received dupilumab + AR101 in the up-dosing period switched to placebo-matched dupilumab + AR101 in the maintenance period
Units
Counts
Participants
OG00040
OG00144
Title
Denominators
Categories
Title
Measurements
OG0004.19± 0.245
OG0014.14± 0.244
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
OG001
ANCOVA
0.8805
P-value is based on treatment difference of the LS mean change using ANCOVA model with baseline tolerated cumulative amount of peanut protein DBPCFC (log transformed) as covariate and the treatment screening peanut-specific IgE level and baseline.
Least Square Mean Difference
-0.05
2-Sided
95
-0.699
0.599
Superiority
Units
Counts
Participants
OG00039
OG00184
Title
Denominators
Categories
Title
Measurements
OG00029.9(3.3 to 82.2)
OG001-60.6(-68.1 to -50.5)
Units
Counts
Participants
OG00029
OG00136
Title
Denominators
Categories
Title
Measurements
OG00010.1(-73.3 to 98.5)
OG001-73.7(-91.7 to -52.5)
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
OG001
ANCOVA
<0.0001
P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate,- and stratification factors and the treatment as fixed factors.
Difference percentage
-85.55
2-Sided
95
-99.47
-73.91
Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.
Superiority
Units
Counts
Participants
OG00029
OG00136
Title
Denominators
Categories
Title
Measurements
OG000-7.2(-84.6 to 94.7)
OG001-73.9(-91.6 to -45.5)
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
OG001
ANCOVA
<0.0001
P-value was based on treatment difference (vs. Continuously on Placebo + AR101) in percent change from baseline using rank-based ANCOVA model with baseline measurement as covariate, and stratification factors and the treatment as fixed factors.
Difference in percentage
-68.78
2-Sided
95
-86.71
-56.40
Median difference and its 95% CIs were estimated with the Hodges-Lehmann method.