Study of Dupilumab in Adult Participants With Active Eosi... | NCT02379052

NCT02379052

Status Module

Sponsor/Collaborators Module

Name	Class
Sanofi	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dupilumab 300 mg QW	Experimental	Participants received SC dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.	Drug: Dupilumab
Placebo	Experimental	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Dupilumab	Drug		Dupilumab 300 mg QW	DUPIXENT® REGN668(SAR231893)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10	The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).	Baseline, Week 10

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10	The SDI is a PRO used to determine frequency/ intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).

Eligibility Module

Eligibility Criteria

Key inclusion criteria:

Documented diagnosis of EoE by endoscopy prior to or at screening
History of on average at least 2 episodes of dysphagia (with intake of solids off anti-inflammatory therapy) per week in the 4 weeks prior to screening and on average at least 2 episodes of documented dysphagia per week in the weeks between screening and baseline; dysphagia is defined as trouble swallowing solid food, or having solid food stick, by participant report
Must remain on a stabilized diet for at least 6 weeks prior to screening and during the course of the study; stable diet is defined as no initiation of single or multiple elimination diets or reintroduction of previously eliminated food groups
Documented history of or presence of any of the following: allergic disease (e.g, allergic asthma, allergic rhinitis, atopic dermatitis (AD), or food allergies), peripheral eosinophil counts ≥0.25 GI/L, or serum total Immunoglobulin E (IgE) ≥100 kU/L

Key Exclusion Criteria:

Prior participation in a dupilumab (anti-IL-4R) clinical trial
Other causes of esophageal eosinophilia or the following diseases: hypereosinophilic syndromes, Churg-Strauss vasculitis, and eosinophilic gastroenteritis
History of achalasia, active Helicobacter pylori infection, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery prior to screening
Any esophageal stricture unable to be passed with a standard, diagnostic, adult (9 to10 mm) upper endoscope or any critical esophageal stricture that requires dilation at screening
History of bleeding disorders or esophageal varices
Use of chronic aspirin, nonsteroidal agents, or anti-coagulants within 2 weeks prior to screening. Participants should not stop these agents solely to become eligible for entry into this study
Treatment with an investigational drug within 2 months or within 5 half-lives (if known), whichever is longer, prior to screening
Use of systemic corticosteroids within 3 months or swallowed topical corticosteroids within 3 months prior to screening
Use of inhaled (pulmonary or nasal) topical corticosteroids within 3 months prior to screening and during the study, except stable dose for at least 3 months prior to screening biopsy, which cannot be changed during the study
Treatment with oral immunotherapy (OIT) within 6 months prior to screening
Allergen immunotherapy unless on stable dose for at least 1 year prior to screening
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

Note: The list of inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a participant's potential participation in this clinical trial.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trial Management	Regeneron Pharmaceuticals	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42031097	Derived	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.
35636689

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
FG001	Dupilumab 300 mg QW

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 10, 2017	Feb 13, 2020

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

The full analysis set (FAS) included all randomized patients. Efficacy analyses were based on the treatment allocated by the interactive voice response system (IVRS)/ interactive web response system (IWRS) at randomization (as randomized).

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
BG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-1.3± 0.57 OG001-3.0± 0.53

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	A 2-step multiple imputation (MI) method addressed missing values ([seeds = 12345 & 54321 in the 2 steps respectively; number of imputations=50]).	0.0304		Least Squares (LS) Mean Difference	-1.7			2-Sided	95	-3.22	-0.16			The confidence interval (CI) with p-value is based on treatment difference (dupilumab vs. placebo) of the LS mean using analysis of covariance (ANCOVA) model with baseline measurement as covariate and the treatment as fixed factor.		Superiority

Secondary

Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10

Full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 10

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12

The SDI is a PRO used to determine frequency/intensity of dysphagia (recall period 1-wk). Frequency of dysphagia events is graded on a 5-pt scale: 0=none, 1=1x/wk, 2=several/wk, 3=1x/day, 4=several/day; intensity is graded on a 6-pt scale: 0=swallowing unrestricted, 1=slight sensation of resistance, 2=slight retching with delay, 3=short period of obstruction necessitating intervention, 4=longer-lasting period of obstruction removable by vomiting, 5=long-lasting complete obstruction requiring endoscopic intervention. Total score ranges from 0-9 (higher score indicates worsening symptoms).

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Score on a Scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percent Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percentage of Participants Achieving a Reduction of ≥ 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 10

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Number

Percentage of Participants

Baseline, Week 10

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percentage of Participants Achieving a Reduction of ≥ 3 Points in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score From Baseline at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Number

Percentage of Participants

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 10

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 10

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Score on a Scale

Baseline, Week 10

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percent Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Absolute Change From Baseline in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Score on a Scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percentage of Participants Achieving ≥ 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 10

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Number

Percentage of Participants

Baseline, Week 10

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percentage of Participants Achieving ≥ 40% Improvement in Weekly Reported Eosinophilic Esophagitis Activity Index (EEsAI) Patient Reported Outcome (PRO) Score From Baseline at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Number

Percentage of Participants

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percent Change From Baseline in Peak Esophageal Intraepithelial Eosinophils of 3 Esophageal Regions at Week 12

Peak eosinophils/high power field (eos/hpf) was determined by counting eosinophils in the most inflamed areas of each esophageal region sampled at each time point and calculating the change in the peak count at each site.

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Percent Change

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Units	Counts
Participants

Secondary

Absolute Change From Baseline in Eosinophilic Esophagitis-Endoscopic Reference Score (EoE-EREFS) by Feature at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Score on a Scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Change From Baseline in Adult Eosinophilic Esophagitis Quality of Life Questionnaire (EoE-QOL-A) Score at Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Least Squares Mean

Standard Error

Score on a Scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Secondary

Percentage of Participants With Use of Rescue Medication or Procedure (e.g., Esophageal Dilation) Through Week 12

FAS included all randomized participants. Efficacy analyses were based on the treatment allocated by the IVRS/IWRS at randomization (as randomized).

Posted

Number

Percent of Participants

Baseline through Week 12

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

Units	Counts
Participants	OG000

Secondary

Percent of Participants With Treatment-Emergent Adverse Events (TEAEs) During the Study

Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that developed or worsened or became serious during the on-treatment period (time from the first dose of study drug up to the end of study (Week 28). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-participant hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.

The safety analysis set (SAF) included all randomized participants who received any study drug, and were analyzed as treated.

Posted

Number

Percent of Participants

Baseline through Week 28

ID	Title	Description
OG000	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.
OG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.

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	Placebo	Participants received matching placebo once weekly (qw) during the 12-week double-blind treatment phase. Participants received 2 injections on day 1, followed by weekly injections.	0	24	0	24	14	24
EG001	Dupilumab 300 mg QW	Participants received subcutaneous (SC) dupilumab 300 mg during the 12-week double-blind treatment phase. Participants received 2 injections (300-mg initial dose, followed by a 300-mg loading dose) on day 1, followed by weekly injections.	0	23	3	23	18	23

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Food allergy	Immune system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0011 events1 affected23 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0011 events1 affected23 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0011 events1 affected23 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ear pain	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0012 events2 affected23 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected24 at risk EG0011 events1 affected23 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0012 events2 affected23 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0012 events2 affected23 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected24 at risk EG0011 events1 affected23 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected24 at risk EG0010 events0 affected23 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0013 events2 affected23 at risk
Injection site erythema	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected24 at risk EG00129 events8 affected23 at risk
Injection site inflammation	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0019 events3 affected23 at risk
Injection site pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected24 at risk EG0018 events2 affected23 at risk
Injection site rash	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG00110 events3 affected23 at risk
Injection site urticaria	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG00110 events2 affected23 at risk
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0012 events2 affected23 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0013 events2 affected23 at risk
Influenza	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected24 at risk EG0010 events0 affected23 at risk
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected24 at risk EG0015 events5 affected23 at risk
Sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected24 at risk EG0011 events1 affected23 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0003 events3 affected24 at risk EG0013 events3 affected23 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0012 events2 affected23 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0012 events2 affected23 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0013 events2 affected23 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0003 events2 affected24 at risk EG0010 events0 affected23 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0002 events2 affected24 at risk EG0011 events1 affected23 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected24 at risk EG0013 events2 affected23 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected24 at risk EG0012 events2 affected23 at risk

ID	Term
D057765	Eosinophilic Esophagitis

Ancestor Terms

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D005759	Gastroenteritis
D004802	Eosinophilia
D007960	Leukocyte Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

ID	Term
C582203	dupilumab

Units	Counts
Participants	OG00024 OG00123

Units	Counts
Participants	OG00024 OG00123

Facility	Status	City	State	ZIP	Country	Contacts
		Idaho Falls	Idaho		United States