Study to Determine the Efficacy and Safety of Dupilumab i... | NCT03633617 | Trialant
NCT03633617
Sponsor
Regeneron Pharmaceuticals
Status
Completed
Last Update Posted
Jun 28, 2023Actual
Enrollment
321Actual
Phase
Phase 3
Conditions
Eosinophilic Esophagitis
Interventions
Dupilumab
Placebo
Countries
United States
Australia
Belgium
Canada
France
Germany
Italy
Netherlands
Spain
Sweden
Switzerland
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03633617
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
R668-EE-1774
Secondary IDs
ID
Type
Description
Link
2018-000844-25
EudraCT Number
Brief Title
Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
Official Title
A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)
Acronym
Not provided
Organization
Regeneron PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Jun 2023
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
Sep 24, 2018Actual
Primary Completion Date
Sep 9, 2021Actual
Completion Date
Jun 7, 2022Actual
First Submitted Date
Aug 14, 2018
First Submission Date that Met QC Criteria
Aug 14, 2018
First Posted Date
Aug 16, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Sep 4, 2022
Results First Submitted that Met QC Criteria
Dec 6, 2022
Results First Posted Date
Dec 28, 2022Actual
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
Jun 2, 2023
Last Update Posted Date
Jun 28, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Regeneron PharmaceuticalsINDUSTRY
Collaborators
Name
Class
Sanofi
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
The primary objectives of the study by study part are:
Part A:
To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B.
Part B:
To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures.
Part C:
To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures.
The secondary objectives of the study are:
To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE
To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses
To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation
To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids
Detailed Description
Not provided
Conditions Module
Conditions
Eosinophilic Esophagitis
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
321Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Dupilumab or Placebo
Experimental
Part A consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Drug: Dupilumab
Drug: Placebo
Part B: Dupilumab or Placebo
Experimental
Part B consists of a 24-week double-blind treatment period. Participants will be randomized to receive dupilumab dosing regimen 1, dupilumab dosing regimen 2 or placebo. At the end of the double-blind treatment visit (week 24), eligible participants may enter Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Drug: Dupilumab
Drug: Placebo
Part C: Dupilumab
Experimental
Part C is a 28-week extended active treatment period. Participants will receive dupilumab dosing regimen 1, dupilumab dosing regimen 2. At the end of the treatment period (week 52), participants will enter a 12-week follow-up period.
Drug: Dupilumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dupilumab
Drug
Solution for injection administered subcutaneously
Part A: Dupilumab or Placebo
Part B: Dupilumab or Placebo
Part C: Dupilumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
At week 24
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline and week 24
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Baseline and week 24
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria (Parts A & B):
A documented diagnosis of EoE by endoscopic biopsy
Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration
History (by patient report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening
Key Exclusion Criteria (Parts A & B):
Body weight ≤40 kg
Prior participation in a dupilumab clinical trial, or past or current treatment with dupilumab
Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening.
Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
Active Helicobacter pylori infection
History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery
Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening
History of bleeding disorders or esophageal varices
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Key Exclusion Criteria (Part C):
Participants who, during Part A or Part B, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present an unreasonable risk for the participant
Participants who became pregnant during Part A or Part B
Participants who are prematurely discontinued from study drug due to an AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part C)
Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment
Strobel MJ, Spergel JM, Chehade M, Dellon ES, Bredenoord AJ, Raphael BP, Almansa C, Tilton ST, Thomas RB. Dupilumab improves symptoms and quality of life in patients with eosinophilic esophagitis: a plain language summary. Immunotherapy. 2026 Mar;18(4):275-283. doi: 10.1080/1750743X.2026.2658371. Epub 2026 May 7.
Part A (24-week DBTP):157 participants screened, 81 randomized and received at least 1 dose of study drug; Part B (24-week DBTP): 462 participants screened, 240 randomized, 239 received treatment (1 participant randomized to placebo did not meet eligibility criteria and was discontinued prior to being treated).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Percent Change From Baseline in DSQ Total Score at Week 24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline and week 24
Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Baseline and week 24
Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Baseline and week 24
Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24
EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Baseline and week 24
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
At week 24
Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Baseline and week 24
NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Baseline and week 24
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
At week 24
Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24
The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
Baseline and week 24
Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
Baseline and week 24
Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
Baseline and week 24
Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24
At week 24
Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24
At week 24
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
At week 52
Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline (of previous study part) and week 52
Percent Change in DSQ Total Score at Week 52
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Baseline (of previous study part) and week 52
Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52
EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Baseline (of previous study part) and week 52
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Baseline (of previous study part) and week 52
Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Baseline (of previous study part) and week 52
Absolute Change in EoEHSS Mean Stage Score at Week 52
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Baseline (of previous study part) and week 52
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
At week 52
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
At week 52
Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52
The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
Baseline (of previous study part) and week 52
Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
Baseline (of previous study part) and week 52
Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
Baseline (of previous study part) and week 52
Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period
Baseline (of Part C) to week 28
NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Baseline (of previous study part) and week 52
NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Baseline (of previous study part) and week 52
Concentration of Functional Dupilumab in Serum at Week 52
Baseline (of Part C) up to week 52
Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response
Number of treatment-emergent ADA responses to dupilumab reported.
Baseline (of previous study part) up to week 52
Scottsdale
Arizona
85259
United States
Regeneron Study Site
Little Rock
Arkansas
72202
United States
Regeneron Study Site
La Jolla
California
92037
United States
Regeneron Study Site
Los Angeles
California
90025
United States
Regeneron Study Site
Mountain View
California
94305
United States
Regeneron Study Site
Orange
California
92868
United States
Regeneron Study Site
Rolling Hills Estates
California
90274
United States
Regeneron Study Site
San Diego
California
92123
United States
Regeneron Study Site
Aurora
Colorado
80045
United States
Regeneron Study Site
Aurora
Colorado
80220
United States
Regeneron Study Site
Colorado Springs
Colorado
80907
United States
Regeneron Study Site
Lone Tree
Colorado
80124
United States
Regeneron Study Site
Bristol
Connecticut
06010
United States
Regeneron Study Site
Miami
Florida
33156
United States
Regeneron Study Site
St. Petersburg
Florida
33701
United States
Regeneron Study Site
Boise
Idaho
83706
United States
Regeneron Study Site
Idaho Falls
Idaho
83404
United States
Regeneron Study Site #1
Chicago
Illinois
60611
United States
Regeneron Study Site #2
Chicago
Illinois
60611
United States
Regeneron Study Site
Park Ridge
Illinois
60068
United States
Regeneron Study Site
Urbana
Illinois
61801
United States
Regeneron Study Site
Indianapolis
Indiana
46202
United States
Regeneron Study Site
Clive
Iowa
50325
United States
Regeneron Study Site
Iowa City
Iowa
52242
United States
Regeneron Study Site
Topeka
Kansas
66606
United States
Regeneron Study Site
Hagerstown
Maryland
21742
United States
Regeneron Study Site
Boston
Massachusetts
02111
United States
Regeneron Study Site
Worcester
Massachusetts
01655
United States
Regeneron Study Site
Ann Arbor
Michigan
48109
United States
Regeneron Study Site
Chesterfield
Michigan
48047
United States
Regeneron Study Site
Plymouth
Minnesota
55446
United States
Regeneron Study Site
Rochester
Minnesota
55905
United States
Regeneron Study Site
Lincoln
Nebraska
68505
United States
Regeneron Study Site
Omaha
Nebraska
68130
United States
Regeneron Study Site
Great Neck
New York
11021
United States
Regeneron Study Site
Great Neck
New York
11023
United States
Regeneron Study Site
New York
New York
10016
United States
Regeneron Study Site
New York
New York
10029
United States
Regeneron Study Site
New York
New York
10032
United States
Regeneron Study Site
The Bronx
New York
10461
United States
Regeneron Study Site
Chapel Hill
North Carolina
27599
United States
Regeneron Study Site
Cincinnati
Ohio
45229
United States
Regeneron Study Site
Dayton
Ohio
45415
United States
Regeneron Study Site
Dublin
Ohio
43016
United States
Regeneron Study Site
Mentor
Ohio
44060
United States
Regeneron Study Site
Hershey
Pennsylvania
17033
United States
Regeneron Study Site
Philadelphia
Pennsylvania
19104
United States
Regeneron Study Site
Charleston
South Carolina
29425
United States
Regeneron Study Site
Greenville
South Carolina
29615
United States
Regeneron Study Site
Johnson City
Tennessee
37604
United States
Regeneron Study Site
Memphis
Tennessee
38103
United States
Regeneron Study Site
Dallas
Texas
75207
United States
Regeneron Study Site
Fort Worth
Texas
76104
United States
Regeneron Study Site
Garland
Texas
75044
United States
Regeneron Study Site
Houston
Texas
77030
United States
Regeneron Study Site
San Antonio
Texas
78229
United States
Regeneron Study Site
Salt Lake City
Utah
84132
United States
Regeneron Study Site
Charlottesville
Virginia
22903
United States
Regeneron Study Site
Roanoke
Virginia
24013
United States
Regeneron Study Site
Seattle
Washington
98115
United States
Regeneron Study Site
Milwaukee
Wisconsin
53226
United States
Regeneron Study Site
Camperdown
New South Wales
2050
Australia
Regeneron Study Site
Woolloongabba
Queensland
4102
Australia
Regeneron Study Site
Elizabeth Vale
South Australia
5112
Australia
Regeneron Study Site
Melbourne
Victoria
3052
Australia
Regeneron Study Site
Bruges
8310
Belgium
Regeneron Study Site
Edegem
2650
Belgium
Regeneron Study Site
Leuven
03000
Belgium
Regeneron Study Site
London
Ontario
N6A5W9
Canada
Regeneron Study Site
Ottawa
Ontario
K1G6S6
Canada
Regeneron Study Site
Montreal
Quebec
H3T1C5
Canada
Regeneron Study Site
Hamilton
L8S 1G5
Canada
Regeneron Study Site
Pessac
33604 Cedex
France
Regeneron Study Site
Toulouse
TSA 50032-31059
France
Regeneron Study Site
Hanover
30459
Germany
Regeneron Study Site
Magdeburg
39120
Germany
Regeneron Study Site
Munich
81675
Germany
Regeneron Study Site
Genoa
16132
Italy
Regeneron Study Site
Milan
20122
Italy
Regeneron Study Site
Naples
80100
Italy
Regeneron Study Site
Pisa
56124
Italy
Regeneron Study Site
Rome
00161
Italy
Regeneron Study Site
Rome
00165
Italy
Regeneron Study Site
Rozzano
20089
Italy
Regeneron Study Site
Amsterdam
1105 AZ
Netherlands
Regeneron Study Site
Maastricht
6229HX
Netherlands
Regeneron Study Site
Nijmegen
6525GA
Netherlands
Regeneron Study Site
Tomelloso
Ciudad Real
13700
Spain
Regeneron Study Site
Barcelona
08036
Spain
Regeneron Study Site
Madrid
28006
Spain
Regeneron Study Site
Stockholm
141 86
Sweden
Regeneron Study Site
Zurich
CH-8091
Switzerland
Regeneron Study Site
London
Whitechapel
E1 1BB
United Kingdom
Regeneron Study Site
Barnsley
Yorkshire
S752EP
United Kingdom
Lim WK, Wipperman MF, Rothenberg ME, Collins MH, Hamon SC, Chehade M, Spergel JM, Gayvert KM, Ehmann PJ, Horowitz JE, Farrell AB, Dellon ES, Maloney J, Radin A, Louisias M, Wolfe K, Akinlade B, Ajithdoss DK, Herman G, Yancopoulos GD, Hamilton JD. Dupilumab normalizes the eosinophilic esophagitis disease transcriptome. J Allergy Clin Immunol. 2026 Apr 22:S0091-6749(26)00263-0. doi: 10.1016/j.jaci.2026.01.033. Online ahead of print.
Bredenoord AJ, Dellon ES, Schlag C, Cianferoni A, Xia C, Pela T, Durrani S, Radwan A, Jacob-Nara JA. Dupilumab is efficacious for eosinophilic esophagitis irrespective of prior swallowed budesonide or fluticasone, or prior treatments used alongside swallowed topical corticosteroids: results from the phase 3, randomized, placebo-controlled, LIBERTY EoE TREET trial. Expert Rev Gastroenterol Hepatol. 2025 Jan-Feb;19(2):197-209. doi: 10.1080/17474124.2025.2461516. Epub 2025 Feb 5.
Spergel JM, Chehade M, Dellon ES, Bredenoord AJ, Sun X, Glotfelty L, Shabbir A, Tilton ST, McCann E. Dupilumab Improves Health-Related Quality of Life and a Range of Symptoms in Patients With Eosinophilic Esophagitis. Am J Gastroenterol. 2024 Dec 1;119(12):2398-2407. doi: 10.14309/ajg.0000000000002924. Epub 2024 Jun 28.
Bredenoord AJ, Dellon ES, Hirano I, Lucendo AJ, Schlag C, Sun X, Glotfelty L, Mannent L, Maloney J, Laws E, Mortensen E, Shabbir A. Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: a subgroup analysis of the phase 3 LIBERTY EoE TREET study. Gut. 2024 Feb 23;73(3):398-406. doi: 10.1136/gutjnl-2023-330220.
McCann E, Chehade M, Spergel JM, Yaworsky A, Symonds T, Stokes J, Tilton ST, Sun X, Kamat S. Validation of the novel Eosinophilic Esophagitis Impact Questionnaire. J Patient Rep Outcomes. 2023 Nov 27;7(1):120. doi: 10.1186/s41687-023-00654-z.
Rothenberg ME, Dellon ES, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Sun X, Hamilton JD, Mortensen E, Laws E, Maloney J, Mannent LP, McCann E, Liu X, Glotfelty L, Shabbir A. Efficacy and safety of dupilumab up to 52 weeks in adults and adolescents with eosinophilic oesophagitis (LIBERTY EoE TREET study): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):990-1004. doi: 10.1016/S2468-1253(23)00204-2. Epub 2023 Aug 31.
Dellon ES, Rothenberg ME, Collins MH, Hirano I, Chehade M, Bredenoord AJ, Lucendo AJ, Spergel JM, Aceves S, Sun X, Kosloski MP, Kamal MA, Hamilton JD, Beazley B, McCann E, Patel K, Mannent LP, Laws E, Akinlade B, Amin N, Lim WK, Wipperman MF, Ruddy M, Patel N, Weinreich DR, Yancopoulos GD, Shumel B, Maloney J, Giannelou A, Shabbir A. Dupilumab in Adults and Adolescents with Eosinophilic Esophagitis. N Engl J Med. 2022 Dec 22;387(25):2317-2330. doi: 10.1056/NEJMoa2205982.
FG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
FG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
FG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
FG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
FG005
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
FG007
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
FG008
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
FG00039 subjects
FG00142 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
Completed week 24 visit for Part A
FG00036 subjects
FG00137 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Week 24 not performed due to Coronavirus Disease-2019 (COVID-19)
FG0001 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Unconfirmed early termination visit
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Part B
Type
Comment
Milestone Data
STARTED
Started Part B (Participants from Part A were not eligible for Part B)
FG0000 subjects
FG0010 subjects
FG00279 subjects
FG00381 subjects
FG00480 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
COMPLETED
Completed week 24 visit for Part B
FG0000 subjects
FG0010 subjects
FG00274 subjects
FG00379 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
Part C (& Follow-up)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG00537 subjects
FG00640 subjects
FG00737 subjects
FG00837 subjects
FG00979 subjects
FG01074 subjects
Completed Week 52 (End of Treatment)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
COMPLETED
Completed follow-up (end of study)
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part A Full analysis set (FAS) includes all randomized participants in Part A; Part B FAS includes all randomized participants in Part B. Participants who participated in Part A were not eligible to participate in Part B.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
BG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
BG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
BG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
BG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00039
BG00142
BG00279
BG00381
BG00480
BG005321
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Part A: Age
Part A Full Analysis Set (FAS): All randomized participants in Part A
Number
Participants
Title
Denominators
Categories
≥ 12 to < 18 years old
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG003
Age, Customized
Part B: Age
Part B FAS: All randomized participants in Part B
Number
Participants
Title
Denominators
Categories
≥ 12 to < 18 years old
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Sex: Female, Male
Part A: Sex: Female, Male
Part A FAS: All randomized participants in Part A
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG002
Sex: Female, Male
Part B: Sex: Female, Male
Part B FAS: All randomized participants in Part B
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Ethnicity (NIH/OMB)
Part A: Ethnicity (NIH/OMB)
Part A FAS: All randomized participants in Part A
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG002
Ethnicity (NIH/OMB)
Part B: Ethnicity (NIH/OMB)
Part B FAS: All randomized participants in Part B
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Race/Ethnicity, Customized
Part A: Race
Part A FAS: All randomized participants in Part A
Number
Participants
Title
Denominators
Categories
White
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG002
Race/Ethnicity, Customized
Part B: Race
Part B FAS: All randomized participants in Part B
Number
Participants
Title
Denominators
Categories
White
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Part A: Dysphagia Symptom Questionnaire (DSQ) Total Score
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Part A FAS: All randomized participants in Part A
Mean
Standard Deviation
Score on a Scale
Title
Denominators
Categories
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG002
Part B: Dysphagia Symptom Questionnaire (DSQ) Total Score
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less frequent or less severe dysphagia.
Part B FAS: All randomized participants in Part B
Mean
Standard Deviation
Score on a Scale
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Part A: Peak Eosinophils (eos) Count of Three Regions per High-power Field (/hpf)
Part A FAS: All randomized participants in Part A
Mean
Standard Deviation
Eosinophils/high-power field (eos/hpf)
Title
Denominators
Categories
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG002
Part B: Peak Eosinophils (eos) Count of Three Regions per High-power Field (/hpf)
Part B FAS: All randomized participants in Part B
Mean
Standard Deviation
Eosinophils/high-power field (eos/hpf)
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Part A: Eosinophilic Esophagitis (EoE) Histological Grade Calculated Mean Score (0 - 3)
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part A FAS: All randomized participants in Part A
Mean
Standard Deviation
Score on a Scale
Title
Denominators
Categories
ParticipantsBG00039
ParticipantsBG001
Part B: Eosinophilic Esophagitis (EoE) Histological Grade Calculated Mean Score (0 - 3)
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part B FAS: All randomized participants in Part B
Mean
Standard Deviation
Score on a Scale
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
Part A: Eosinophilic Esophagitis (EoE) Histological Stage Calculated Mean Score (0 - 3)
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part A FAS: All randomized participants in Part A
Mean
Standard Deviation
Score on a Scale
Title
Denominators
Categories
ParticipantsBG00039
ParticipantsBG001
Part B: Eosinophilic Esophagitis (EoE) Histological Stage Calculated Mean Score (0 - 3)
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part B FAS: All randomized participants in Part B
Mean
Standard Deviation
Score on a Scale
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG001
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 Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Part A Full Analysis Set (FAS): All participants randomized to Part A (Participants considered non-responder after rescue treatment use and multiple imputation (MI) method for missing due to COVID-19); Part B FAS: All participants randomized to Part B (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)
Posted
Number
95% Confidence Interval
Percentage of Participants
At week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG003
Title
Denominators
Categories
Title
Measurements
OG0005.1(0.63 to 17.32)
OG00159.5(43.28 to 74.37)
OG0026.3(2.09 to 14.16)
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
OG001
Cochran-Mantel-Haenszel
<0.0001
Difference in proportion
55.3
2-Sided
95
39.58
71.04
Difference is dupilumab minus placebo
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
Primary
Absolute Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Part A Full Analysis Set (FAS): All participant randomized to Part A (MI method with data set to missing after rescue treatment use); Part B FAS: All participants randomized to Part B (MI method with data set to missing after rescue treatment use)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Part A FAS (Worst-observation carried forward [WOCF]-MI method with data set to missing after rescue treatment use); Part B FAS (WOCF-MI method with WOCF for rescue treatment use and missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)
Posted
Least Squares Mean
95% Confidence Interval
Percentage of Change
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Percent Change From Baseline in DSQ Total Score at Week 24
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)
Posted
Least Squares Mean
95% Confidence Interval
Percentage of Change
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG002
Part B: Placebo
Secondary
Absolute Change From Baseline in Eosinophilic Esophagitis Histology Scoring System (EoEHSS) Mean Grade Score at Week 24
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part A FAS (WOCF-MI method with data set to missing after rescue treatment use); Part B FAS (WOCF-MI method with WOCF for rescue treatment use and missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Absolute Change From Baseline in EoEHSS Mean Stage Score at Week 24
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part A FAS (WOCF-MI Method With Data Set to Missing After Rescue Treatment Use); Part B FAS (WOCF-MI Method with WOCF for Rescue Treatment Use and Missing Not Due to COVID-19 and MI Method for Missing or Dosing Interruption Due to COVID-19)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Absolute Change From Baseline in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 24
EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Part A FAS (WOCF-MI Method With Data Set to Missing After Rescue Treatment Use); Part B FAS (WOCF-MI Method with WOCF for Rescue Treatment Use and Missing Not Due to COVID-19 and MI Method for Missing or Dosing Interruption Due to COVID-19)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Part A FAS (Participants considered non-responder after rescue treatment use and MI method for missing due to COVID-19); Part B FAS (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19).
Posted
Number
95% Confidence Interval
Percentage of Participants
At week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Normalized Enrichment Score (NES) for the Relative Change From Baseline in the EoE Diagnostic Panel (EDP) at Week 24
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Part A FAS (Participants with NES Score in Part A; Last observation carried forward [LOCF] method with data set to missing after rescue treatment use); Part B FAS (Participants with NES Score in Part B; LOCF method with data set to missing after rescue treatment use)
Posted
Number
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
NES for the Relative Change From Baseline in the Type 2 Inflammation Signature (T2INF) at Week 24
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Part A FAS (Participants with NES Score in Part A; LOCF Method with data set to missing after rescue treatment use); Part B FAS (Participants with NES Score in Part B; LOCF method with data set to missing after rescue treatment use)
Posted
Number
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 24
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Part A FAS (Participants considered non-responder after rescue treatment use and MI method for missing due to COVID-19); Part B FAS (Participants considered non-responder after rescue treatment use or missing not due to COVID-19 and MI method for missing or dosing interruption due to COVID-19)
Posted
Number
95% Confidence Interval
Percentage of Participants
At week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Absolute Change From Baseline in Health-related Quality of Life (QoL) Average Score as Measured by EoE Impact Questionnaire (EoE-IQ) at Week 24
The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE Symptom Questionnaire (EoE-SQ) at Week 24
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 24
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
Part A FAS (MI method with data set to missing after rescue treatment use); Part B FAS (MI method with data set to missing after rescue treatment use)
Posted
Least Squares Mean
95% Confidence Interval
Score on a Scale
Baseline and week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Percentage of Participants Who Received Rescue Treatment During the Placebo-controlled, Double-blind Treatment Period at Week 24
Part A FAS; Part B FAS
Posted
Number
95% Confidence Interval
Percentage of Participants
At week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Absolute Change From Baseline in Esophageal Distensibility Plateau Measured by Functional Lumen Imaging, if Collected, at Week 24
Due to only 7 participants in Part B with change from baseline at week 24 data available across 3 treatment groups, results are not reported to protect the confidentiality of the participants.
Posted
At week 24
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Secondary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤6 Eosinophils Per High-power Field (Eos/Hpf) in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Number
Percentage of Participants
At week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Absolute Change in Dysphagia Symptom Questionnaire (DSQ) Total Score at Week 52
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Percent Change in DSQ Total Score at Week 52
The DSQ is used to measure the frequency and intensity of dysphagia. DSQ scores can range from 0 to 84, with a lower score indicating less-frequent or less-severe dysphagia.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Percentage of Change
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Absolute Change in EoE Endoscopic Reference Total Score (EoE-EREFS) at Week 52
EoE esophageal characteristics analyzed based on the EoE-EREFS, a scoring system for inflammatory and remodeling features of disease. The overall total score ranges from 0 to 18 with higher number indicating worse disease.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Median
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Percent Change in Peak Esophageal Intraepithelial Eosinophil Count (Eos/Hpf) in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal). A greater esophageal intraepithelial eosinophil count from baseline indicates worsening disease.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Percentage of Change
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Secondary
Absolute Change in EoE Histology Scoring System (EoEHSS) Mean Grade Score at Week 52
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Absolute Change in EoEHSS Mean Stage Score at Week 52
Severity (grade) and extent (stage) of esophageal abnormalities were scored by blinded, central pathologists using a 4-point scale (0 normal; 3 maximum change) for eight features: eosinophil density, basal zone hyperplasia, eosinophil abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells and lamina propria fibrosis (absent/present). Higher score indicates greater severity and extent of histological abnormalities.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Secondary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of <15 Eos/Hpf in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Number
Percentage of Participants
At week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Percentage of Participants Achieving Peak Esophageal Intraepithelial Eosinophil Count of ≤1 Eos/Hpf in All Three Regions at Week 52
Esophageal intraepithelial eosinophil count obtained by esophageal endoscopy with biopsies (all 3 esophageal regions: proximal, mid, and distal).
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Number
Percentage of Participants
At week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Absolute Change in Health-related QOL as Measured by EoE-IQ at Week 52
The EoE-IQ measures impact of EoE on emotional, social, work & school, & sleep aspects. Participants were asked to respond to 11 questions based on experience living with EoE during past 7 days. Response to each item is on a 5-point scale (1=Not at all [impacted] 2=A little, 3=Somewhat, 4=Quite a bit, 5=Extremely [impacted]). The average score is the sum of non-missing responses divided by the number of items with non-missing responses. The average score can range from 1 to 5; a higher score is indicative of a more negative impact.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Absolute Change From Baseline in Severity of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the severity of each symptom based on the worst experience in the past 7 days is on a scale of 0 to 10 (higher is worse). The EoE-SQ severity score is calculated as the sum of the severity scores from questions 1 to 3 (chest pain, stomach pain, burning feeling in chest), which could range from 0 to 30; a higher score is indicative of more severe symptoms.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Absolute Change From Baseline in Frequency of EoE Symptoms Other Than Dysphagia as Measured by EoE-SQ at Week 52
The EoE-SQ asks about symptoms that participants with EoE may have (chest pain, stomach pain, burning feeling in chest, food or liquid coming back up into throat, throwing up) during the past 7 days. Response to the frequency of each symptom is on a 5-point scale (1 = 'Never', 2 = 'One day', 3 = ' 2-6 days', 4 = 'Once a day', 5 = 'More than once a day'). The EoE-SQ frequency score is calculated as the sum of the frequency scores from the 5 items which could range from 5 to 25; a higher score is indicative of higher frequency of symptoms.
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Mean
Standard Deviation
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Percentage of Participants Who Received Rescue Medication During the 28-week Extended Active Treatment Period
Posted
Number
Percentage of Participants
Baseline (of Part C) to week 28
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Secondary
NES for the Relative Change From Baseline in EoE Diagnostic Panel (EDP) at Week 52
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Median
Full Range
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Secondary
NES for the Relative Change in the Type 2 Inflammation Signature (T2INF) at Week 52
NES reflects the degree to which the activity level of a set of disease transcripts is overrepresented at the extremes (top or bottom) of the entire ranked list of transcripts within a sample and is normalized by accounting for the number of transcripts in the set. An NES of 0 indicates no change from baseline, a negative score reflects a reduction in the disease score (more like normal) and a positive score reflects worsening (more active disease).
Part C safety analysis set (SAF): All participants who were randomized in Part A/B, entered Part C, and received any study drug in Part C.
Posted
Median
Full Range
Score on a Scale
Baseline (of previous study part) and week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Secondary
Concentration of Functional Dupilumab in Serum at Week 52
The PK analysis set (PKAS) for Part A and Part C included all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug in the corresponding study part. The PKAS for Part B and Part C included all randomized participants who received any study drug and who had at least one non-missing drug concentration result following the first dose of study drug in the corresponding study part.
Posted
Mean
Standard Deviation
milligrams per liter (mg/L)
Baseline (of Part C) up to week 52
ID
Title
Description
OG000
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Secondary
Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response
Number of treatment-emergent ADA responses to dupilumab reported.
ADA analysis set (AAS) Parts A & C: All participants who received any study drug & had at least 1 non-missing ADA result from dupilumab ADA assay after first dose of study drug in corresponding study part (according to treatment actually received); AAS Parts B & C: All participants who received any study drug & had at least 1 non-missing ADA result from dupilumab ADA assay after first dose of study drug in corresponding study part (according to treatment actually received).
Posted
Number
Events
Baseline (of previous study part) up to week 52
ID
Title
Description
OG000
Part A: Placebo
Participants received placebo matching dupilumab subcutaneously (SC) during Part A (a 24-week double-blind treatment period [DBTP]). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG001
Part A: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part A (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Time Frame
From day of first dose up to 12 weeks after end of treatment visit (week 52)
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
Part A: Placebo
Participants received placebo matching dupilumab SC during Part A (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part A entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.
0
39
2
39
28
39
EG001
Part A: Dupilumab 300 mg QW
Participants received dupilumab 300 mg SC QW during Part A (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part A entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.
0
42
2
42
26
42
EG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part B entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.
0
78
1
78
41
78
EG003
Part B: Dupilumab 300 mg Q2W
Participants received dupilumab 300 mg Q2W SC during Part B (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part B entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.
0
81
2
81
57
81
EG004
Part B: Dupilumab 300 mg QW
Participants received dupilumab 300 mg SC QW during Part B (24-week DBTP). At end of week 24 visit (one-week after last dose of study drug during DBTP), eligible participants from Part B entered into 28-week extended treatment (Part C) and 12-week follow-up. Participants who did not enter into Part C, entered follow-up period.
0
80
5
80
50
80
EG005
Part C: Dupilumab 300 mg Q2W (Placebo in Part B)
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
0
37
1
37
19
37
EG006
Part C: Dupilumab 300 mg QW (Placebo in Part A or B)
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up. Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
0
74
3
74
44
74
EG007
Part C: Dupilumab 300 mg Q2W (Part B Regimen Continued)
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
0
79
1
79
47
79
EG008
Part C: Dupilumab 300 mg QW (Part A or B Regimen Continued)
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up. Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
0
114
4
114
62
114
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Suicidal ideation
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG0032 events2 affected81 at risk
EG0040 events0 affected80 at risk
EG0050 events0 affected37 at risk
EG0060 events0 affected74 at risk
EG0070 events0 affected79 at risk
EG0080 events0 affected114 at risk
Depression suicidal
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected78 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Campylobacter colitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Blood creatine phosphokinase abnormal
Investigations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Substance use disorder
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Chest pain
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Pneumonia mycoplasmal
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Open globe injury
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Injection site erythema
General disorders
MedDRA (25.0)
Systematic Assessment
EG00022 events6 affected39 at risk
EG00112 events4 affected42 at risk
EG00242 events9 affected78 at risk
EG00393 events18 affected81 at risk
EG00425 events8 affected80 at risk
EG00532 events2 affected37 at risk
EG00613 events6 affected74 at risk
EG00736 events6 affected79 at risk
EG00821 events10 affected114 at risk
Injection site reaction
General disorders
MedDRA (25.0)
Systematic Assessment
EG00019 events5 affected39 at risk
EG00145 events9 affected42 at risk
EG00269 events16 affected78 at risk
EG003
Injection site pain
General disorders
MedDRA (25.0)
Systematic Assessment
EG0006 events3 affected39 at risk
EG0019 events5 affected42 at risk
EG00221 events4 affected78 at risk
EG003
Injection site oedema
General disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0017 events2 affected42 at risk
EG0027 events3 affected78 at risk
EG003
Injection site pruritus
General disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected42 at risk
EG0025 events3 affected78 at risk
EG003
Injection site bruising
General disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events1 affected39 at risk
EG0012 events1 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Injection site swelling
General disorders
MedDRA (25.0)
Systematic Assessment
EG0005 events1 affected39 at risk
EG0017 events5 affected42 at risk
EG00210 events2 affected78 at risk
EG003
Pyrexia
General disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0012 events2 affected42 at risk
EG0021 events1 affected78 at risk
EG003
Fatigue
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected42 at risk
EG00220 events4 affected78 at risk
EG003
Injection site urticaria
General disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0024 events2 affected78 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0004 events4 affected39 at risk
EG0016 events5 affected42 at risk
EG0024 events3 affected78 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected78 at risk
EG003
COVID-19
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0014 events4 affected42 at risk
EG0022 events2 affected78 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0005 events4 affected39 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected78 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0004 events4 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0004 events3 affected39 at risk
EG0012 events1 affected42 at risk
EG0027 events7 affected78 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0003 events2 affected39 at risk
EG0011 events1 affected42 at risk
EG0024 events4 affected78 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0012 events2 affected42 at risk
EG00212 events8 affected78 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0012 events2 affected42 at risk
EG0026 events4 affected78 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0029 events4 affected78 at risk
EG003
Headache
Nervous system disorders
MedDRA (25.0)
Systematic Assessment
EG00011 events4 affected39 at risk
EG0017 events2 affected42 at risk
EG00228 events9 affected78 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected42 at risk
EG0027 events6 affected78 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0011 events1 affected42 at risk
EG0022 events2 affected78 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (25.0)
Systematic Assessment
EG0002 events2 affected39 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected78 at risk
EG003
Hypertension
Vascular disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected78 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA (25.0)
Systematic Assessment
EG0001 events1 affected39 at risk
EG0010 events0 affected42 at risk
EG0023 events3 affected78 at risk
EG003
Eosinophilic oesophagitis
Gastrointestinal disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Food allergy
Immune system disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected78 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (25.0)
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected78 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.
Subject randomized, but did not receive study drug; did not qualify for study
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG00532 subjects
FG00638 subjects
FG00734 subjects
FG00836 subjects
FG00974 subjects
FG01065 subjects
FG0040 subjects
FG00530 subjects
FG00635 subjects
FG00733 subjects
FG00836 subjects
FG00967 subjects
FG01064 subjects
0 subjects
FG0057 subjects
FG0065 subjects
FG0074 subjects
FG0081 subjects
FG00912 subjects
FG01010 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0106 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0063 subjects
FG0071 subjects
FG0080 subjects
FG0097 subjects
FG0102 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
COVID-19 related
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0101 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0009
BG00111
BG00520
≥ 18 to < 40 years old
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG00022
BG00113
BG00535
≥ 40 to < 65 years old
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0008
BG00118
BG00526
≥ 65 years old
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0000
BG0010
BG0050
79
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG00226
BG00327
BG00426
BG00579
≥ 18 to < 40 years old
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG00238
BG00335
BG00438
BG005
≥ 40 to < 65 years old
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG00215
BG00318
BG00415
BG005
≥ 65 years old
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0020
BG0031
BG0041
BG005
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
Female
BG00018
BG00114
BG00532
Male
BG00021
BG00128
BG00549
79
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
Female
BG00221
BG00336
BG00430
BG00587
Male
BG00258
BG00345
BG00450
BG005153
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
Hispanic or Latino
BG0001
BG0014
BG0055
Not Hispanic or Latino
BG00038
BG00138
BG00576
Unknown or Not Reported
BG0000
BG0010
BG0050
79
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
Hispanic or Latino
BG0025
BG0033
BG0045
BG00513
Not Hispanic or Latino
BG00274
BG00377
BG00475
BG005226
Unknown or Not Reported
BG0020
BG0031
BG0040
BG0051
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG00037
BG00141
BG00578
Black or African American
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0001
BG0011
BG0052
Asian
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0000
BG0010
BG0050
Other
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0001
BG0010
BG0051
Not reported
ParticipantsBG00039
ParticipantsBG00142
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0000
BG0010
BG0050
79
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG00272
BG00374
BG00471
BG005217
Black or African American
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0023
BG0033
BG0042
BG005
Asian
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0021
BG0031
BG0043
BG005
Other
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0022
BG0032
BG0043
BG005
Not reported
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0021
BG0031
BG0041
BG005
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG00035.1± 12.11
BG00132.2± 12.66
BG00533.6± 12.41
79
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG00236.1± 10.55
BG00335.6± 12.24
BG00438.4± 10.70
BG00536.7± 11.22
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG00096.5± 54.69
BG00182.6± 41.02
BG00589.3± 48.29
79
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG00284.3± 41.20
BG00387.7± 49.37
BG00489.2± 46.67
BG00587.1± 45.76
42
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0001.324± 0.4676
BG0011.260± 0.4088
BG0051.291± 0.4365
0
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0021.226± 0.3996
BG0031.245± 0.3721
BG0041.305± 0.3882
BG0051.259± 0.3865
42
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG00581
Title
Measurements
BG0001.376± 0.3972
BG0011.299± 0.3334
BG0051.336± 0.3653
0
ParticipantsBG00279
ParticipantsBG00381
ParticipantsBG00480
ParticipantsBG005240
Title
Measurements
BG0021.216± 0.3608
BG0031.248± 0.3182
BG0041.294± 0.3256
BG0051.253± 0.3353
81
OG00480
60.5
(49.01 to 71.19)
OG00458.8(47.18 to 69.65)
<0.0001
Difference in proportion
56.0
2-Sided
95
43.44
68.54
Difference is dupilumab minus placebo
Superiority
OG002
OG004
Cochran-Mantel-Haenszel
<0.0001
Difference in proportion
53.5
2-Sided
95
41.20
65.79
Difference is dupilumab minus placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-9.60(-15.056 to -4.136)
OG001-21.92(-26.870 to -16.967)
OG002-13.86(-17.605 to -10.120)
OG003-14.37(-18.018 to -10.723)
OG004-23.78(-27.427 to -20.131)
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
0.0004
LS Mean Difference
-12.32
2-Sided
95
-19.107
-5.537
Dupilumab group vs. Placebo
Superiority
OG002
OG003
ANCOVA
0.8393
LS Mean Difference
-0.51
2-Sided
95
-5.423
4.406
Dupilumab group vs. Placebo
Superiority
OG002
OG004
ANCOVA
<0.0001
LS Mean Difference
-9.92
2-Sided
95
-14.811
-5.022
Dupilumab group vs. Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-2.98(-17.886 to 11.921)
OG001-71.24(-84.863 to -57.613)
OG0028.38(-11.677 to 28.433)
OG003-70.84(-87.095 to -54.585)
OG004-80.24(-96.589 to -63.895)
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
LS Mean Difference
-68.26
2-Sided
95
-86.896
-49.615
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
OG003
ANCOVA
<0.0001
LS Mean Difference
-79.22
2-Sided
95
-103.098
-55.338
Dupilumab 300 mg Q2W vs Placebo
Superiority
OG002
OG004
ANCOVA
<0.0001
LS Mean Difference
-88.62
2-Sided
95
-112.194
-65.046
Dupilumab 300 mg QW vs Placebo
Superiority
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-31.68(-47.545 to -15.818)
OG001-69.17(-83.578 to -54.752)
OG002-41.43(-51.749 to -31.116)
OG003-45.78(-55.658 to -35.904)
OG004-64.32(-74.267 to 54.382)
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
0.0002
LS Mean Difference
-37.48
2-Sided
95
-57.222
-17.745
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
OG003
ANCOVA
0.5243
LS Mean Difference
-4.35
2-Sided
95
-17.734
9.038
Dupilumab 300 mg Q2W vs Placebo
Superiority
OG002
OG004
ANCOVA
0.0008
LS Mean Difference
-22.89
2-Sided
95
-36.272
-9.513
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-0.001(-0.1166 to 0.1139)
OG001-0.761(-0.8732 to -0.6484)
OG002-0.148(-0.2379 to -0.0584)
OG003-0.814(-0.8958 to -0.7317)
OG004-0.830(-0.9136 to -0.7463)
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
LS Mean Difference
-0.759
2-Sided
95
-0.9061
-0.6127
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
OG003
ANCOVA
<0.0001
LS Mean Difference
-0.666
2-Sided
95
-0.7773
-0.5538
Dupilumab 300 mg Q2W vs Placebo
Superiority
OG002
OG004
ANCOVA
<0.0001
LS Mean Difference
-0.682
2-Sided
95
-0.7929
-0.5707
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-0.012(-0.1243 to 0.0995)
OG001-0.753(-0.8627 to -0.6441)
OG002-0.132(-0.2179 to -0.0464)
OG003-0.793(-0.8713 to -0.7144)
OG004-0.804(-0.8839 to -0.7237)
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
LS Mean Difference
-0.741
2-Sided
95
-0.8842
-0.5978
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
OG003
ANCOVA
<0.0001
LS Mean Difference
-0.661
2-Sided
95
-0.7674
-0.5540
Dupilumab 300 mg Q2W vs Placebo
Superiority
OG002
OG004
ANCOVA
<0.0001
LS Mean Difference
-0.672
2-Sided
95
-0.7778
-0.5655
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-0.3(-1.11 to 0.50)
OG001-3.2(-3.98 to -2.38)
OG002-0.6(-1.37 to 0.12)
OG003-4.6(-5.24 to -3.89)
OG004-4.5(-5.17 to -3.77)
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
LS Mean Difference
-2.9
2-Sided
95
-3.91
-1.84
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
OG003
ANCOVA
<0.0001
LS Mean Difference
-3.9
2-Sided
95
-4.86
-3.02
Dupilumab 300 mg Q2W vs Placebo
Superiority
OG002
OG004
ANCOVA
<0.0001
LS Mean Difference
-3.8
2-Sided
95
-4.77
-2.93
Dupilumab 300 mg QW vs Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG0007.7(1.62 to 20.87)
OG00164.3(48.03 to 78.45)
OG0027.6(2.84 to 15.80)
OG00379.0(68.54 to 87.27)
OG00482.5(72.38 to 90.09)
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
<0.0001
Difference in proportion
57.5
2-Sided
95
41.69
73.33
Difference is Dupilumab minus Placebo
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.0001
Difference in proportion
72.4
2-Sided
95
61.05
83.70
Difference is Dupilumab minus Placebo
Superiority
OG002
OG004
Cochran-Mantel-Haenszel
<0.0001
Difference in proportion
74.9
2-Sided
95
64.25
85.50
Difference is Dupilumab minus Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00029
OG00131
OG00241
OG00344
OG00440
Title
Denominators
Categories
Title
Measurements
OG000-0.160
OG001-2.660
OG002-0.730
OG003-2.675
OG004-2.665
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
Wilcoxon rank-sum test
<0.0001
Hodges-Lehmann estimator
-2.250
2-Sided
95
-2.7200
-1.7300
Median Difference is Dupilumab minus Placebo
Superiority
OG002
OG003
Wilcoxon rank-sum test
<0.0001
Hodges-Lehmann estimator
-1.840
2-Sided
95
-2.4200
-1.1100
Median Difference is Dupilumab minus Placebo
Superiority
OG002
OG004
Wilcoxon rank-sum test
<0.0001
Hodges-Lehmann estimator
-1.850
2-Sided
95
-2.4400
-1.1500
Median Difference is Dupilumab minus Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00029
OG00131
OG00241
OG00344
OG00440
Title
Denominators
Categories
Title
Measurements
OG000-0.320
OG001-1.970
OG002-0.640
OG003-1.950
OG004-1.930
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
Wilcoxon rank-sum test
<0.0001
Hodges-Lehmann estimator
-1.590
2-Sided
95
-1.7400
-1.2700
Median Difference is Dupilumab minus Placebo
Superiority
OG002
OG003
Wilcoxon rank-sum test
<0.0001
Hodges-Lehmann estimator
-1.255
2-Sided
95
-1.7300
-1.0500
Median Difference is Dupilumab minus Placebo
Superiority
OG002
OG004
Wilcoxon rank-sum test
<0.0001
Hodges-Lehmann estimator
-1.275
2-Sided
95
-1.8200
-1.0700
Median Difference is Dupilumab minus Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.00 to 9.03)
OG00121.4(10.30 to 36.81)
OG0021.3(0.03 to 6.85)
OG00327.2(17.87 to 38.19)
OG00428.8(19.18 to 39.95)
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
0.0017
Difference in proportion
21.9
2-Sided
95
9.42
34.38
Difference is Dupilumab minus Placebo
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
<0.0001
Difference in proportion
27.6
2-Sided
95
17.20
38.09
Difference is Dupilumab minus Placebo
Superiority
OG002
OG004
Cochran-Mantel-Haenszel
<0.0001
Difference in proportion
28.9
2-Sided
95
18.36
39.46
Difference is Dupilumab minus Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-0.246(-0.4659 to -0.0266)
OG001-0.614(-0.8140 to -0.4149)
OG002-0.578(-0.6977 to -0.4585)
OG003-0.593(-0.7152 to -0.4706)
OG004-0.887(-1.0050 to -0.7685)
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
0.0077
LS Mean Difference
-0.368
2-Sided
95
-0.6388
-0.0975
Dupilumab group vs Placebo
Superiority
OG002
OG003
ANCOVA
0.8586
LS Mean Difference
-0.015
2-Sided
95
-0.1782
0.1485
Dupilumab group vs. Placebo
Superiority
OG002
OG004
ANCOVA
0.0002
LS Mean Difference
-0.309
2-Sided
95
-0.4703
-0.1471
Dupilumab group vs. Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-3.9(-5.46 to -2.31)
OG001-5.8(-7.24 to -4.44)
OG002-4.0(-5.16 to -2.80)
OG003-4.5(-5.59 to -3.32)
OG004-5.4(-6.60 to 4.27)
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
0.0467
LS Mean Difference
-2.0
2-Sided
95
-3.87
-0.03
Dupilumab group vs. Placebo
Superiority
OG002
OG003
ANCOVA
0.5469
LS Mean Difference
-0.5
95
-2.03
1.08
Dupilumab group vs. Placebo
Superiority
OG002
OG004
ANCOVA
0.0718
LS Mean Difference
-1.5
2-Sided
95
-3.0
0.13
Dupilumab group vs. Placebo
Superiority
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG000-1.7(-2.67 to -0.71)
OG001-3.4(-4.29 to -2.53)
OG002-2.6(-3.25 to -1.87)
OG003-3.0(-3.69 to -2.36)
OG004-3.9(-4.61 to -3.25)
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
0.0051
LS Mean Difference
-1.7
2-Sided
95
-2.93
-0.52
Dupilumab group vs. Placebo
Superiority
OG002
OG003
ANCOVA
0.3152
LS Mean Difference
-0.5
2-Sided
95
-1.38
0.44
Dupilumab group vs. Placebo
Superiority
OG002
OG004
ANCOVA
0.0037
LS Mean Difference
-1.4
2-Sided
95
-2.30
0.45
Dupilumab group vs. Placebo
Superiority
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG00039
OG00142
OG00279
OG00381
OG00480
Title
Denominators
Categories
Title
Measurements
OG00012.8(4.30 to 27.43)
OG0010.0(0.00 to 8.41)
OG0022.5(0.31 to 8.85)
OG0031.2(0.03 to 6.69)
OG0042.5(0.30 to 8.74)
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
0.0170
Difference in proportion
-12.7
2-Sided
95
-23.21
-2.26
Difference is Dupilumab minus Placebo
Superiority
OG002
OG003
Cochran-Mantel-Haenszel
0.5493
Difference in proportion
-1.3
2-Sided
95
-5.51
2.93
Difference is Dupilumab minus Placebo
Superiority
OG002
OG004
Cochran-Mantel-Haenszel
0.9887
Difference in proportion
0.0
2-Sided
95
-4.9
5.02
Difference is Dupilumab minus Placebo
Superiority
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00134
OG00232
OG00337
OG00473
OG00565
Title
Denominators
Categories
Title
Measurements
OG00060.0
OG00155.9
OG00271.9
OG00367.6
OG00474.0
OG00584.6
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00023
OG00129
OG00227
OG00324
OG00452
OG00554
Title
Denominators
Categories
Title
Measurements
OG000-21.71± 17.143
OG001-23.44± 16.149
OG002-23.69± 13.737
OG003-27.25± 11.457
OG004-20.87± 16.387
OG005-30.26± 15.389
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00023
OG00129
OG00227
OG00324
OG00452
OG00554
Title
Denominators
Categories
Title
Measurements
OG000-65.87± 49.705
OG001-75.93± 36.892
OG002-71.01± 37.256
OG003-78.13± 31.003
OG004-61.19± 44.447
OG005-80.74± 32.866
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00135
OG00231
OG00337
OG00473
OG00563
Title
Denominators
Categories
Title
Measurements
OG000-3.9± 2.74
OG001-4.1± 3.37
OG002-4.3± 3.21
OG003-6.1± 3.60
OG004-5.2± 3.40
OG005-5.3± 2.85
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00134
OG00232
OG00337
OG00473
OG00565
Title
Denominators
Categories
Title
Measurements
OG000-83.76± 24.996
OG001-88.59± 13.506
OG002-91.20± 13.037
OG003-84.21± 42.169
OG004-84.78± 40.973
OG005-95.85± 4.037
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00134
OG00232
OG00337
OG00473
OG00565
Title
Denominators
Categories
Title
Measurements
OG000-0.873± 0.5506
OG001-0.873± 0.3537
OG002-0.779± 0.4292
OG003-0.906± 0.3936
OG004-0.838± 0.4039
OG005-0.968± 0.4293
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00134
OG00232
OG00337
OG00473
OG00565
Title
Denominators
Categories
Title
Measurements
OG000-0.874± 0.4630
OG001-0.891± 0.2770
OG002-0.710± 0.3783
OG003-0.871± 0.3510
OG004-0.809± 0.3434
OG005-0.932± 0.3730
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00134
OG00232
OG00337
OG00473
OG00565
Title
Denominators
Categories
Title
Measurements
OG00070.0
OG00182.4
OG00287.5
OG00378.4
OG00483.6
OG005100
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00030
OG00134
OG00232
OG00337
OG00473
OG00565
Title
Denominators
Categories
Title
Measurements
OG00026.7
OG00129.4
OG00240.6
OG00316.2
OG00431.5
OG00530.8
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00027
OG00127
OG00231
OG00335
OG00467
OG00556
Title
Denominators
Categories
Title
Measurements
OG000-0.954± 0.6690
OG001-0.911± 0.6344
OG002-1.021± 0.7169
OG003-0.858± 0.6360
OG004-0.773± 0.6217
OG005-0.935± 0.6883
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00027
OG00127
OG00232
OG00335
OG00468
OG00557
Title
Denominators
Categories
Title
Measurements
OG000-7.2± 6.46
OG001-5.9± 6.80
OG002-6.2± 6.42
OG003-5.9± 6.47
OG004-4.7± 5.99
OG005-6.4± 6.86
OG002
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00027
OG00127
OG00232
OG00335
OG00468
OG00557
Title
Denominators
Categories
Title
Measurements
OG000-4.3± 3.78
OG001-3.2± 3.50
OG002-4.0± 3.54
OG003-3.8± 3.62
OG004-3.6± 3.45
OG005-4.7± 4.03
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00037
OG00140
OG00237
OG00337
OG00479
OG00574
Title
Denominators
Categories
Title
Measurements
OG0008.1
OG0010
OG0022.7
OG0032.7
OG0040
OG0051.4
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00027
OG00130
OG00217
OG00324
OG00460
OG00549
Title
Denominators
Categories
Title
Measurements
OG000-2.580(-2.87 to -0.45)
OG001-2.670(-2.83 to -1.09)
OG002-2.28(-2.8 to -0.8)
OG003-2.62(-2.9 to -2.1)
OG004-2.64(-2.9 to 1.2)
OG005-2.69(-2.9 to -0.6)
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00027
OG00130
OG00217
OG00324
OG00460
OG00549
Title
Denominators
Categories
Title
Measurements
OG000-1.940(-2.11 to -0.42)
OG001-1.970(-2.07 to -0.95)
OG002-1.76(-2.1 to -1.0)
OG003-1.96(-2.1 to -1.5)
OG004-1.95(-2.1 to 0.3)
OG005-1.97(-2.2 to -0.7)
OG003
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Units
Counts
Participants
OG00034
OG00138
OG00236
OG00337
OG00477
OG00569
Title
Denominators
Categories
Week 32
ParticipantsOG00028
ParticipantsOG00124
ParticipantsOG00231
ParticipantsOG00335
ParticipantsOG00471
ParticipantsOG00558
Title
Measurements
OG000101± 44.6
OG001205± 76.8
OG00246.0± 33.1
OG003
Week 52
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00233
ParticipantsOG00337
OG002
Part B: Placebo
Participants received placebo matching dupilumab SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG003
Part B: Dupilumab 300 mg SC Q2W
Participants received dupilumab 300 mg once every 2 weeks (Q2W) SC during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG004
Part B: Dupilumab 300 mg SC QW
Participants received dupilumab 300 milligrams (mg) SC once per week (QW) during Part B (a 24-week DBTP). At end of double-blind treatment visit, week 24 (one-week after last dose of study drug during the DBTP), eligible participants may enter into Part C. Participants who do not enter Part C will enter a 12-week follow-up period.
OG005
Part A/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part A, received dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW in Part A continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG007
Part B/C: Placebo / Dupilumab 300 mg Q2W
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg Q2W for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
OG008
Part B/C: Placebo / Dupilumab 300 mg QW
Participants randomized to placebo in Part B were re-randomized in a 1:1 ratio to receive dupilumab 300 mg QW for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg Q2W in Part B continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.
Participants randomized to dupilumab 300 mg QW during Part B, continued to receive the same regimen for 28-week extended treatment (Part C) followed by 12-week follow-up. Participants who did not enter into Part C, entered follow-up.