Open-label Study of Dupilumab in Patients With Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT01949311

Recruitment Status : Completed

First Posted : September 24, 2013

Results First Posted : October 17, 2023

Last Update Posted : October 17, 2023

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Sponsor:

Collaborator:

Sanofi

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Atopic Dermatitis
Intervention	Drug: Dupilumab
Enrollment	2733

Participant Flow

Recruitment Details
Pre-assignment Details	A total of 1297 participants completed the study and 1380 participants had withdrawn. Withdrawal from study included study terminated by the Sponsor (708), and withdrawal by the participant (375), Adverse Event (107), Lost to Follow-Up (73), Lack of Efficacy (50), Protocol Deviation (34), Pregnancy (20), Physician Decision (9), and reasons not specified (4)


Arm/Group Title	Dupilumab
Arm/Group Description	Participants received repeated dose...
Arm/Group Description	Participants received repeated doses of dupilumab
Period Title: Overall Study
Started	2677
Completed	1297
Not Completed	1380
Reason Not Completed
Lost to Follow-up	73
Terminated by Sponsor	708
Withdrawal by Subject	375
Lack of Efficacy	50
Protocol Deviation	34
Pregnancy	20
Physician Decision	9
Other	4
Adverse Event	107

Baseline Characteristics

Arm/Group Title		Dupilumab
Arm/Group Description		Participants received repeated dose...
Arm/Group Description		Participants received repeated doses of dupilumab
Overall Number of Baseline Participants		2677
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	2677 participants
		39.2 (13.42)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2677 participants
	Female	1066 39.8%
	Male	1611 60.2%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2677 participants
	Hispanic or Latino	94 3.5%
	Not Hispanic or Latino	2532 94.6%
	Unknown or Not Reported	51 1.9%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	2677 participants
	American Indian or Alaska Native	0 0.0%
	Asian	541 20.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	147 5.5%
	White	1936 72.3%
	More than one race	33 1.2%
	Unknown or Not Reported	20 0.7%

Outcome Measures

1.Primary Outcome


Title	Number of Treatment Emergent Adverse Events (TEAEs)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated).


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Number of Events
	14717

2.Primary Outcome


Title	OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product
Description	Adverse events of special interest in this study include: Anaphylactic...
Description	Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time Frame	Up to 24 Weeks

Outcome Measure Data

Analysis Population Description

The sub-study SAF includes all patients who receive new dupilumab drug product in the sub-study.


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab during the Ophthalmology Sub-study
Overall Number of Participants Analyzed	50
Measure Type: Number Unit of Measure: Events
	0

3.Secondary Outcome


Title	Number of Serious Adverse Events (SAEs) of Special Interest
Description	Adverse events of special interest in this study include: Anaphylactic...
Description	Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated).


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Events
	9

4.Secondary Outcome


Title	Rate of AESIs
Description	Rate (events per patient-year) of AESIs ...
Description	Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated).


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Events per Patient-Year
	2.762

5.Secondary Outcome


Title	Number of AESIs
Description	Adverse events of special interest in this study include: Anaphylactic...
Description	Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms)
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated).


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Events
	161

6.Secondary Outcome


Title	Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit
Description	IGA is an assessment scale used to determine severity of hand and foot...
Description	IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration.
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated).


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Baseline of study	Number Analyzed	2677 participants
Baseline of study		12.0
Week 4	Number Analyzed	2650 participants
Week 4		31.1
Week 16	Number Analyzed	2590 participants
Week 16		46.7
Week 36	Number Analyzed	1313 participants
Week 36		46.2
Week 52	Number Analyzed	893 participants
Week 52		53.8
Week 100	Number Analyzed	1019 participants
Week 100		58.2
Week 124	Number Analyzed	478 participants
Week 124		59.6
Week 156	Number Analyzed	116 participants
Week 156		67.2
Week 172	Number Analyzed	187 participants
Week 172		71.1
Week 188	Number Analyzed	62 participants
Week 188		56.5
Week 204	Number Analyzed	101 participants
Week 204		64.4
Week 220	Number Analyzed	138 participants
Week 220		81.2
Week 236	Number Analyzed	10 participants
Week 236		50.0
End of Study (Extension)	Number Analyzed	326 participants
End of Study (Extension)		67.5

7.Secondary Outcome


Title	Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
Description	The EASI score was used to measure the severity and extent of atopic d...
Description	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Baseline of study	Number Analyzed	2647 participants
Baseline of study		33.4
Week 4	Number Analyzed	2620 participants
Week 4		65.3
Week 16	Number Analyzed	2560 participants
Week 16		82.0
Week 36	Number Analyzed	1289 participants
Week 36		85.3
Week 52	Number Analyzed	883 participants
Week 52		88.8
Week 100	Number Analyzed	999 participants
Week 100		91.4
Week 124	Number Analyzed	473 participants
Week 124		92.0
Week 156	Number Analyzed	114 participants
Week 156		89.5
Week 172	Number Analyzed	187 participants
Week 172		94.1
Week 188	Number Analyzed	62 participants
Week 188		96.8
Week 204	Number Analyzed	99 participants
Week 204		90.9
Week 220	Number Analyzed	138 participants
Week 220		93.5
Week 236	Number Analyzed	10 participants
Week 236		100
End of Study (Extension)	Number Analyzed	324 participants
End of Study (Extension)		88.9

8.Secondary Outcome


Title	Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit
Description	Low disease activity state is defined as an IGA score of ≤2 [mil...
Description	Low disease activity state is defined as an IGA score of ≤2 [mild = 2, almost clear = 1, or clear = 0]
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Baseline of study	Number Analyzed	2677 participants
Baseline of study		34.7
Week 4	Number Analyzed	2650 participants
Week 4		70.0
Week 16	Number Analyzed	2590 participants
Week 16		83.0
Week 36	Number Analyzed	1313 participants
Week 36		84.6
Week 52	Number Analyzed	893 participants
Week 52		89.6
Week 100	Number Analyzed	1019 participants
Week 100		90.9
Week 124	Number Analyzed	478 participants
Week 124		93.1
Week 156	Number Analyzed	116 participants
Week 156		94.8
Week 172	Number Analyzed	187 participants
Week 172		96.3
Week 188	Number Analyzed	62 participants
Week 188		96.8
Week 204	Number Analyzed	101 participants
Week 204		96.0
Week 220	Number Analyzed	138 participants
Week 220		97.1
Week 236	Number Analyzed	10 participants
Week 236		90.0
End of Study (Extension)	Number Analyzed	326 participants
End of Study (Extension)		92.6

9.Secondary Outcome


Title	Change From Baseline in EASI Score at Each Visit
Description	The EASI score was used to measure the severity and extent of atopic d...
Description	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Score on a scale
Week 4	Number Analyzed	2650 participants
Week 4		-8.59 (10.196)
Week 16	Number Analyzed	2590 participants
Week 16		-11.89 (12.583)
Week 36	Number Analyzed	1313 participants
Week 36		-17.32 (13.989)
Week 52	Number Analyzed	894 participants
Week 52		-16.46 (13.719)
Week 100	Number Analyzed	1019 participants
Week 100		-17.99 (14.049)
Week 124	Number Analyzed	478 participants
Week 124		-17.68 (13.794)
Week 156	Number Analyzed	116 participants
Week 156		-14.23 (14.358)
Week 172	Number Analyzed	187 participants
Week 172		-13.23 (13.651)
Week 188	Number Analyzed	62 participants
Week 188		-19.24 (11.253)
Week 204	Number Analyzed	101 participants
Week 204		-14.50 (15.615)
Week 220	Number Analyzed	138 participants
Week 220		-12.75 (14.444)
Week 236	Number Analyzed	10 participants
Week 236		-16.69 (9.743)
End of Study (Extension)	Number Analyzed	326 participants
End of Study (Extension)		-13.14 (14.614)

10.Secondary Outcome


Title	Percent Change From Baseline in EASI Score at Each Visit
Description	The EASI score was used to measure the severity and extent of atopic d...
Description	The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Percent of Change
Week 4	Number Analyzed	2584 participants
Week 4		-42.02 (88.963)
Week 16	Number Analyzed	2527 participants
Week 16		-54.82 (316.630)
Week 36	Number Analyzed	1304 participants
Week 36		-60.40 (603.886)
Week 52	Number Analyzed	885 participants
Week 52		-75.76 (73.014)
Week 100	Number Analyzed	1013 participants
Week 100		-82.61 (29.534)
Week 124	Number Analyzed	477 participants
Week 124		-84.15 (27.737)
Week 156	Number Analyzed	115 participants
Week 156		-83.45 (32.410)
Week 172	Number Analyzed	178 participants
Week 172		-74.98 (78.138)
Week 188	Number Analyzed	62 participants
Week 188		-88.72 (15.122)
Week 204	Number Analyzed	101 participants
Week 204		-70.91 (74.941)
Week 220	Number Analyzed	129 participants
Week 220		-30.79 (370.994)
Week 236	Number Analyzed	10 participants
Week 236		-87.56 (10.851)
End of Study (Extension)	Number Analyzed	316 participants
End of Study (Extension)		-55.44 (213.819)

11.Secondary Outcome


Title	Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
Description	EASI-50 was defined as >=50% reduction in EASI scores from baseline...
Description	EASI-50 was defined as >=50% reduction in EASI scores from baseline of the parent study
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Week 4	Number Analyzed	2620 participants
Week 4		86.0
Week 16	Number Analyzed	2560 participants
Week 16		95.0
Week 36	Number Analyzed	1289 participants
Week 36		96.7
Week 52	Number Analyzed	883 participants
Week 52		97.4
Week 100	Number Analyzed	999 participants
Week 100		98.5
Week 124	Number Analyzed	473 participants
Week 124		98.3
Week 156	Number Analyzed	114 participants
Week 156		97.4
Week 172	Number Analyzed	187 participants
Week 172		98.4
Week 188	Number Analyzed	62 participants
Week 188		100
Week 204	Number Analyzed	99 participants
Week 204		94.9
Week 220	Number Analyzed	138 participants
Week 220		97.8
Week 236	Number Analyzed	10 participants
Week 236		100
End of Study (Extension)	Number Analyzed	324 participants
End of Study (Extension)		96.9

12.Secondary Outcome


Title	Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit
Description	EASI-90 was defined as >=90% reduction in EASI scores from baseline...
Description	EASI-90 was defined as >=90% reduction in EASI scores from baseline of the parent study
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Week 4	Number Analyzed	2620 participants
Week 4		38.6
Week 16	Number Analyzed	2560 participants
Week 16		57.7
Week 36	Number Analyzed	1289 participants
Week 36		59.7
Week 52	Number Analyzed	883 participants
Week 52		68.4
Week 100	Number Analyzed	999 participants
Week 100		73.0
Week 124	Number Analyzed	473 participants
Week 124		74.4
Week 156	Number Analyzed	114 participants
Week 156		76.3
Week 172	Number Analyzed	187 participants
Week 172		81.8
Week 188	Number Analyzed	62 participants
Week 188		72.6
Week 204	Number Analyzed	99 participants
Week 204		75.8
Week 220	Number Analyzed	138 participants
Week 220		84.1
Week 236	Number Analyzed	10 participants
Week 236		70.0
End of Study (Extension)	Number Analyzed	324 participants
End of Study (Extension)		76.2

13.Secondary Outcome


Title	Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study
Description	The Pruritus NRS is an assessment tool for patients to report the inte...
Description	The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description

The safety analysis set (SAF) includes all patients who received any study drug; it is based on the treatment received. Participants recorded Pruritus score using IVRS (Interactive Voice Recording System) at specified timepoints


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Score on a Scale
Week 1	Number Analyzed	2150 participants
Week 1		-2.86 (2.492)
Week 4	Number Analyzed	2249 participants
Week 4		-3.81 (2.403)
Week 16	Number Analyzed	1865 participants
Week 16		-4.44 (2.377)
Week 36	Number Analyzed	1924 participants
Week 36		-4.67 (2.365)
Week 52	Number Analyzed	1579 participants
Week 52		-4.76 (2.371)
Week 100	Number Analyzed	875 participants
Week 100		-4.69 (2.315)
Week 124	Number Analyzed	590 participants
Week 124		-4.56 (2.359)
Week 156	Number Analyzed	391 participants
Week 156		-4.37 (2.352)
Week 172	Number Analyzed	291 participants
Week 172		-4.64 (2.256)
Week 188	Number Analyzed	241 participants
Week 188		-4.73 (2.194)
Week 204	Number Analyzed	200 participants
Week 204		-4.83 (2.341)
Week 220	Number Analyzed	192 participants
Week 220		-4.90 (2.231)
Week 236	Number Analyzed	189 participants
Week 236		-4.81 (2.308)
Week 252	Number Analyzed	178 participants
Week 252		-4.89 (2.201)
Week 272	Number Analyzed	135 participants
Week 272		-4.69 (2.238)

14.Secondary Outcome


Title	Percent Change From Baseline in Pruritus NRS
Description	The Pruritus NRS is an assessment tool for patients to report the inte...
Description	The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Percent Change
Week 1	Number Analyzed	1846 participants
Week 1		-9.55 (40.989)
Week 4	Number Analyzed	1859 participants
Week 4		-28.88 (41.792)
Week 16	Number Analyzed	1520 participants
Week 16		-38.96 (47.891)
Week 36	Number Analyzed	1595 participants
Week 36		-41.38 (52.300)
Week 52	Number Analyzed	1316 participants
Week 52		-46.41 (41.912)
Week 100	Number Analyzed	708 participants
Week 100		-50.62 (42.112)
Week 124	Number Analyzed	454 participants
Week 124		-51.47 (39.063)
Week 156	Number Analyzed	297 participants
Week 156		-48.16 (55.076)
Week 172	Number Analyzed	247 participants
Week 172		-50.30 (42.907)
Week 188	Number Analyzed	191 participants
Week 188		-50.56 (43.444)
Week 204	Number Analyzed	169 participants
Week 204		-52.53 (43.465)
Week 220	Number Analyzed	162 participants
Week 220		-51.18 (39.244)
Week 236	Number Analyzed	160 participants
Week 236		-51.67 (37.690)
Week 252	Number Analyzed	148 participants
Week 252		-51.01 (47.328)
Week 272	Number Analyzed	111 participants
Week 272		-46.23 (46.404)

15.Secondary Outcome


Title	Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline
Description	The Pruritus NRS is an assessment tool for patients to report the inte...
Description	The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Week 1	Number Analyzed	2204 participants
Week 1		11.9
Week 4	Number Analyzed	2304 participants
Week 4		28.3
Week 16	Number Analyzed	1908 participants
Week 16		39.3
Week 36	Number Analyzed	1969 participants
Week 36		43.8
Week 52	Number Analyzed	1609 participants
Week 52		45.9
Week 100	Number Analyzed	893 participants
Week 100		51.1
Week 124	Number Analyzed	601 participants
Week 124		48.8
Week 156	Number Analyzed	396 participants
Week 156		46.5
Week 172	Number Analyzed	294 participants
Week 172		54.1
Week 188	Number Analyzed	242 participants
Week 188		52.5
Week 204	Number Analyzed	202 participants
Week 204		56.9
Week 220	Number Analyzed	194 participants
Week 220		51.5
Week 236	Number Analyzed	191 participants
Week 236		51.3
Week 252	Number Analyzed	178 participants
Week 252		56.2
Week 272	Number Analyzed	136 participants
Week 272		50.0

16.Secondary Outcome


Title	Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline
Description	The Pruritus NRS is an assessment tool for patients to report the inte...
Description	The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Measure Type: Number Unit of Measure: Percentage of Participants
Week 1	Number Analyzed	2204 participants
Week 1		7.0
Week 4	Number Analyzed	2304 participants
Week 4		18.6
Week 16	Number Analyzed	1908 participants
Week 16		29.3
Week 36	Number Analyzed	1969 participants
Week 36		33.3
Week 52	Number Analyzed	1609 participants
Week 52		35.4
Week 100	Number Analyzed	893 participants
Week 100		41.4
Week 124	Number Analyzed	601 participants
Week 124		39.4
Week 156	Number Analyzed	396 participants
Week 156		35.6
Week 172	Number Analyzed	294 participants
Week 172		42.9
Week 188	Number Analyzed	242 participants
Week 188		40.9
Week 204	Number Analyzed	202 participants
Week 204		44.1
Week 220	Number Analyzed	194 participants
Week 220		40.2
Week 236	Number Analyzed	191 participants
Week 236		37.2
Week 252	Number Analyzed	178 participants
Week 252		42.7
Week 272	Number Analyzed	136 participants
Week 272		36.0

17.Secondary Outcome


Title	Percentage of Participants Requiring Rescue Treatment: Overall
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

This included all participants who received any study drug.


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Percentage of Participants
	1.7

18.Secondary Outcome


Title	Percentage of Participants Requiring Rescue Treatment: Systemic Treatment
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

This included all participants who received any study drug.


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Percentage of Participants
	1.6

19.Secondary Outcome


Title	Percentage of Participants Requiring Rescue Treatment: Phototherapy
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 272 weeks

Outcome Measure Data

Analysis Population Description

This included all participants who received any study drug.


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	2677
Measure Type: Number Unit of Measure: Percentage of Participants
	0.0747

20.Secondary Outcome


Title	Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI)
Description	The DLQI is a 10-item, validated questionnaire used in clinical practi...
Description	The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description

Administered only to the subset of participants who fluently spoke the language for which a validated translation of the questionnaire was available, at time points according to the Schedule of Events as described in the study protocol. This included all participants who received any study drug.


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Score on a scale
Baseline of Current Study	Number Analyzed	2677 participants
Baseline of Current Study		8.5 (7.11)
Week 12	Number Analyzed	2200 participants
Week 12		-4.9 (5.93)
Week 24	Number Analyzed	1601 participants
Week 24		-6.0 (6.41)
Week 36	Number Analyzed	1300 participants
Week 36		-6.5 (6.51)
Week 48	Number Analyzed	2243 participants
Week 48		-5.6 (6.20)
Week 76	Number Analyzed	415 participants
Week 76		-7.2 (6.41)
Week 100	Number Analyzed	877 participants
Week 100		-7.3 (6.66)
Week 124	Number Analyzed	118 participants
Week 124		-7.9 (6.40)
Week 148	Number Analyzed	11 participants
Week 148		-8.3 (5.14)
End of Study	Number Analyzed	69 participants
End of Study		-3.6 (7.37)

21.Secondary Outcome


Title	Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM)
Description	The POEM is a 7-item, validated questionnaire used in clinical practic...
Description	The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL.
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description

Administered only to the subset of participants who fluently speak the language for which a validated translation of the questionnaire is available. This included all participants who received any study drug.


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Score on a scale
Week 12	Number Analyzed	2205 participants
Week 12		-7.7 (7.32)
Week 24	Number Analyzed	1598 participants
Week 24		-9.3 (7.44)
Week 36	Number Analyzed	1302 participants
Week 36		-10.0 (7.46)
Week 48	Number Analyzed	2247 participants
Week 48		-8.8 (7.46)
Week 76	Number Analyzed	422 participants
Week 76		-11.6 (7.79)
Week 100	Number Analyzed	879 participants
Week 100		-11.4 (7.30)
Week 124	Number Analyzed	118 participants
Week 124		-12.7 (7.11)
Week 148	Number Analyzed	11 participants
Week 148		-10.5 (6.06)
End of Study	Number Analyzed	70 participants
End of Study		-4.5 (10.91)

22.Secondary Outcome


Title	Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D)
Description	The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized...
Description	The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized measure of health status developed by the EuroQOL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The minimum value for the single index utility score is -0.594 (Best imaginable health state) and the maximum value for the single index utility score is 1 (Worst imaginable health state).
Time Frame	Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)"

Outcome Measure Data

Analysis Population Description


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		2677
Mean (Standard Deviation) Unit of Measure: Score on a scale
Week 12	Number Analyzed	1909 participants
Week 12		0.2769 (0.31571)
Week 24	Number Analyzed	1327 participants
Week 24		0.3001 (0.32062)
Week 36	Number Analyzed	1047 participants
Week 36		0.3056 (0.33204)
Week 48	Number Analyzed	1994 participants
Week 48		0.2854 (0.31017)
Week 76	Number Analyzed	314 participants
Week 76		0.2965 (0.30658)
Week 100	Number Analyzed	752 participants
Week 100		0.3217 (0.33832)
Week 124	Number Analyzed	95 participants
Week 124		0.3242 (0.28937)
Week 148	Number Analyzed	7 participants
Week 148		0.3046 (0.26337)
End of Study	Number Analyzed	52 participants
End of Study		0.1864 (0.32838)

23.Secondary Outcome


Title	OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to week 12

Outcome Measure Data

Analysis Population Description

The sub-study ADA population includes all treated patients who receive new dupilumab drug product and have at least one non-missing anti-dupilumab antibody result at any time during the sub-study period after the first dose of new dupilumab drug product.


Arm/Group Title		Dupilumab
Arm/Group Description:		Participants received repeated dose...
Arm/Group Description:		Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed		50
Mean (Standard Deviation) Unit of Measure: mg/L
Week 0	Number Analyzed	50 participants
Week 0		65.9 (40.8)
Week 12	Number Analyzed	48 participants
Week 12		65.4 (34.7)

24.Secondary Outcome


Title	OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product
Description	For participants receiving dupilumab from a new manufacturing process,...
Description	For participants receiving dupilumab from a new manufacturing process, ADA baseline was defined as the baseline visit in the sub-study, or at the end of the main study, dependent on available data.
Time Frame	Up to 24 Weeks

Outcome Measure Data

Analysis Population Description


Arm/Group Title	Dupilumab
Arm/Group Description:	Participants received repeated dose...
Arm/Group Description:	Participants received repeated doses of dupilumab
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	From first dose to end of study (plus extension), approximately 272 weeks
Adverse Event Reporting Description	Participants received repeated doses of dupilumab

Arm/Group Title	Dupilumab
Arm/Group Description	Participants received repeated dose...
Arm/Group Description	Participants received repeated doses of dupilumab
All-Cause Mortality
	Dupilumab
	Affected / at Risk (%)
Total	3/2677 (0.11%)
Serious Adverse Events Serious Adverse Events
	Dupilumab
	Affected / at Risk (%)	# Events
Total	283/2677 (10.57%)
Blood and lymphatic system disorders
Febrile neutropenia ^† 1	1/2677 (0.04%)	1
Haemolytic anaemia ^† 1	1/2677 (0.04%)	1
Thrombocytopenia ^† 1	1/2677 (0.04%)	1
Cardiac disorders
Myocardial infarction ^† 1	3/2677 (0.11%)	3
Atrial fibrillation ^† 1	2/2677 (0.07%)	2
Acute myocardial infarction ^† 1	1/2677 (0.04%)	1
Angina pectoris ^† 1	1/2677 (0.04%)	3
Aortic valve incompetence ^† 1	1/2677 (0.04%)	1
Arrhythmia ^† 1	1/2677 (0.04%)	1
Atrial flutter ^† 1	1/2677 (0.04%)	1
Bundle branch block left ^† 1	1/2677 (0.04%)	1
Chordae tendinae rupture ^† 1	1/2677 (0.04%)	1
Coronary artery disease ^† 1	1/2677 (0.04%)	1
Myocardial ischaemia ^† 1	1/2677 (0.04%)	1
Prinzmetal angina ^† 1	1/2677 (0.04%)	1
Congenital, familial and genetic disorders
Atrial septal defect ^† 1	1/2677 (0.04%)	1
Congenital knee deformity ^† 1	1/2677 (0.04%)	1
Dolichocolon ^† 1	1/2677 (0.04%)	1
Ear and labyrinth disorders
Meniere's disease ^† 1	1/2677 (0.04%)	1
Endocrine disorders
Goitre ^† 1	2/2677 (0.07%)	2
Thyroid mass ^† 1	1/2677 (0.04%)	1
Eye disorders
Cataract ^† 1	3/2677 (0.11%)	3
Ectropion ^† 1	2/2677 (0.07%)	2
Entropion ^† 1	2/2677 (0.07%)	2
Trichiasis ^† 1	2/2677 (0.07%)	2
Atopic keratoconjunctivitis ^† 1	1/2677 (0.04%)	1
Chalazion ^† 1	1/2677 (0.04%)	1
Corneal erosion ^† 1	1/2677 (0.04%)	3
Corneal neovascularisation ^† 1	1/2677 (0.04%)	2
Corneal perforation ^† 1	1/2677 (0.04%)	1
Eyelid cyst ^† 1	1/2677 (0.04%)	1
Keratoconus ^† 1	1/2677 (0.04%)	1
Mydriasis ^† 1	1/2677 (0.04%)	1
Optic neuropathy ^† 1	1/2677 (0.04%)	1
Retinal artery occlusion ^† 1	1/2677 (0.04%)	1
Retinal detachment ^† 1	1/2677 (0.04%)	1
Ulcerative keratitis ^† 1	1/2677 (0.04%)	1
Gastrointestinal disorders
Inguinal hernia ^† 1	5/2677 (0.19%)	5
Colitis ^† 1	2/2677 (0.07%)	2
Large intestine polyp ^† 1	2/2677 (0.07%)	2
Umbilical hernia ^† 1	2/2677 (0.07%)	2
Ascites ^† 1	1/2677 (0.04%)	1
Diarrhoea ^† 1	1/2677 (0.04%)	1
Diverticular perforation ^† 1	1/2677 (0.04%)	1
Enterocolitis ^† 1	1/2677 (0.04%)	1
Haematochezia ^† 1	1/2677 (0.04%)	1
Hiatus hernia ^† 1	1/2677 (0.04%)	1
Incarcerated umbilical hernia ^† 1	1/2677 (0.04%)	1
Intestinal polyp ^† 1	1/2677 (0.04%)	1
Pancreatitis chronic ^† 1	1/2677 (0.04%)	2
General disorders
Death ^† 1	3/2677 (0.11%)	3
Non-cardiac chest pain ^† 1	2/2677 (0.07%)	3
Chest pain ^† 1	1/2677 (0.04%)	1
Cyst ^† 1	1/2677 (0.04%)	1
Device dislocation ^† 1	1/2677 (0.04%)	1
Hepatobiliary disorders
Cholelithiasis ^† 1	4/2677 (0.15%)	4
Acute hepatic failure ^† 1	1/2677 (0.04%)	1
Bile duct stone ^† 1	1/2677 (0.04%)	1
Cholecystitis ^† 1	1/2677 (0.04%)	1
Cholestasis of pregnancy ^† 1	1/2677 (0.04%)	1
Drug-induced liver injury ^† 1	1/2677 (0.04%)	1
Hepatic cirrhosis ^† 1	1/2677 (0.04%)	1
Hepatorenal syndrome ^† 1	1/2677 (0.04%)	1
Jaundice cholestatic ^† 1	1/2677 (0.04%)	1
Immune system disorders
Anaphylactic reaction ^† 1	3/2677 (0.11%)	4
Food allergy ^† 1	2/2677 (0.07%)	2
Contrast media allergy ^† 1	1/2677 (0.04%)	1
Sarcoidosis ^† 1	1/2677 (0.04%)	1
Serum sickness ^† 1	1/2677 (0.04%)	1
Infections and infestations
Appendicitis ^† 1	6/2677 (0.22%)	6
Corona virus infection ^† 1	3/2677 (0.11%)	3
Erysipelas ^† 1	3/2677 (0.11%)	3
Gastroenteritis ^† 1	3/2677 (0.11%)	3
Pilonidal cyst ^† 1	3/2677 (0.11%)	3
Chronic tonsillitis ^† 1	2/2677 (0.07%)	2
Diverticulitis ^† 1	2/2677 (0.07%)	3
Eczema herpeticum ^† 1	2/2677 (0.07%)	2
Influenza ^† 1	2/2677 (0.07%)	2
Peritonsillar abscess ^† 1	2/2677 (0.07%)	2
Pneumonia ^† 1	2/2677 (0.07%)	2
Urosepsis ^† 1	2/2677 (0.07%)	2
Abdominal abscess ^† 1	1/2677 (0.04%)	1
Bronchitis ^† 1	1/2677 (0.04%)	1
Bronchopneumonia ^† 1	1/2677 (0.04%)	1
Cellulitis ^† 1	1/2677 (0.04%)	1
Chronic sinusitis ^† 1	1/2677 (0.04%)	1
Gastroenteritis bacterial ^† 1	1/2677 (0.04%)	1
Hand-foot-and-mouth disease ^† 1	1/2677 (0.04%)	1
Hepatitis A ^† 1	1/2677 (0.04%)	1
Herpes ophthalmic ^† 1	1/2677 (0.04%)	1
Herpes zoster disseminated ^† 1	1/2677 (0.04%)	1
Impetigo ^† 1	1/2677 (0.04%)	1
Infected dermal cyst ^† 1	1/2677 (0.04%)	1
Infective exacerbation of chronic obstructive airways disease ^† 1	1/2677 (0.04%)	1
Keratitis bacterial ^† 1	1/2677 (0.04%)	1
Lung infection ^† 1	1/2677 (0.04%)	1
Parotitis ^† 1	1/2677 (0.04%)	1
Periorbital cellulitis ^† 1	1/2677 (0.04%)	1
Perirectal abscess ^† 1	1/2677 (0.04%)	1
Pyelonephritis ^† 1	1/2677 (0.04%)	1
Superinfection bacterial ^† 1	1/2677 (0.04%)	1
Urinary tract infection ^† 1	1/2677 (0.04%)	1
Viral corneal ulcer ^† 1	1/2677 (0.04%)	1
Wound infection staphylococcal ^† 1	1/2677 (0.04%)	1
Injury, poisoning and procedural complications
Ligament rupture ^† 1	5/2677 (0.19%)	5
Ankle fracture ^† 1	4/2677 (0.15%)	4
Joint dislocation ^† 1	3/2677 (0.11%)	3
Meniscus injury ^† 1	3/2677 (0.11%)	3
Clavicle fracture ^† 1	2/2677 (0.07%)	2
Contusion ^† 1	2/2677 (0.07%)	2
Lower limb fracture ^† 1	2/2677 (0.07%)	2
Upper limb fracture ^† 1	2/2677 (0.07%)	2
Alcohol poisoning ^† 1	1/2677 (0.04%)	1
Comminuted fracture ^† 1	1/2677 (0.04%)	1
Concussion ^† 1	1/2677 (0.04%)	1
Craniocerebral injury ^† 1	1/2677 (0.04%)	1
Fall ^† 1	1/2677 (0.04%)	1
Injury ^† 1	1/2677 (0.04%)	1
Ligament injury ^† 1	1/2677 (0.04%)	1
Ligament sprain ^† 1	1/2677 (0.04%)	1
Limb traumatic amputation ^† 1	1/2677 (0.04%)	1
Muscle injury ^† 1	1/2677 (0.04%)	1
Post procedural haemorrhage ^† 1	1/2677 (0.04%)	1
Pubis fracture ^† 1	1/2677 (0.04%)	1
Rib fracture ^† 1	1/2677 (0.04%)	1
Sternal fracture ^† 1	1/2677 (0.04%)	1
Thermal burn ^† 1	1/2677 (0.04%)	1
Transplant dysfunction ^† 1	1/2677 (0.04%)	1
Traumatic arthrosis ^† 1	1/2677 (0.04%)	1
Traumatic intracranial haemorrhage ^† 1	1/2677 (0.04%)	1
Wound dehiscence ^† 1	1/2677 (0.04%)	1
Investigations
Intraocular pressure increased ^† 1	1/2677 (0.04%)	1
Metabolism and nutrition disorders
Hypokalaemia ^† 1	1/2677 (0.04%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis ^† 1	11/2677 (0.41%)	12
Intervertebral disc protrusion ^† 1	3/2677 (0.11%)	3
Rotator cuff syndrome ^† 1	3/2677 (0.11%)	3
Intervertebral disc disorder ^† 1	2/2677 (0.07%)	2
Arthralgia ^† 1	1/2677 (0.04%)	1
Fibromyalgia ^† 1	1/2677 (0.04%)	1
Foot deformity ^† 1	1/2677 (0.04%)	1
Intervertebral disc degeneration ^† 1	1/2677 (0.04%)	1
Rheumatoid arthritis ^† 1	1/2677 (0.04%)	1
Spinal osteoarthritis ^† 1	1/2677 (0.04%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin ^† 1	8/2677 (0.30%)	14
Mycosis fungoides ^† 1	3/2677 (0.11%)	3
Prostate cancer ^† 1	3/2677 (0.11%)	3
Squamous cell carcinoma ^† 1	3/2677 (0.11%)	3
Uterine leiomyoma ^† 1	3/2677 (0.11%)	3
Basal cell carcinoma ^† 1	2/2677 (0.07%)	2
Breast cancer ^† 1	2/2677 (0.07%)	2
Hodgkin's disease ^† 1	2/2677 (0.07%)	2
Intraductal proliferative breast lesion ^† 1	2/2677 (0.07%)	2
Small cell lung cancer ^† 1	2/2677 (0.07%)	2
Adenocarcinoma of colon ^† 1	1/2677 (0.04%)	1
Bladder transitional cell carcinoma ^† 1	1/2677 (0.04%)	1
Bowen's disease ^† 1	1/2677 (0.04%)	1
Breast cancer female ^† 1	1/2677 (0.04%)	1
Breast cancer stage I ^† 1	1/2677 (0.04%)	1
Colon adenoma ^† 1	1/2677 (0.04%)	1
Colon cancer ^† 1	1/2677 (0.04%)	1
Granular cell tumour ^† 1	1/2677 (0.04%)	1
Hodgkin's disease lymphocyte predominance type stage III ^† 1	1/2677 (0.04%)	1
Laryngeal cancer stage II ^† 1	1/2677 (0.04%)	1
Malignant melanoma ^† 1	1/2677 (0.04%)	1
Ovarian germ cell teratoma benign ^† 1	1/2677 (0.04%)	1
Pancreatic carcinoma metastatic ^† 1	1/2677 (0.04%)	1
Plasma cell myeloma ^† 1	1/2677 (0.04%)	1
Plasmacytoma ^† 1	1/2677 (0.04%)	1
Prostate cancer metastatic ^† 1	1/2677 (0.04%)	1
Seminoma ^† 1	1/2677 (0.04%)	1
Squamous cell carcinoma of the tongue ^† 1	1/2677 (0.04%)	1
T-cell lymphoma ^† 1	1/2677 (0.04%)	1
Uterine cancer ^† 1	1/2677 (0.04%)	1
Nervous system disorders
Syncope ^† 1	5/2677 (0.19%)	6
Migraine ^† 1	2/2677 (0.07%)	2
Amnesia ^† 1	1/2677 (0.04%)	1
Carotid artery stenosis ^† 1	1/2677 (0.04%)	1
Carpal tunnel syndrome ^† 1	1/2677 (0.04%)	1
Cerebrovascular accident ^† 1	1/2677 (0.04%)	1
Dizziness ^† 1	1/2677 (0.04%)	1
Epilepsy ^† 1	1/2677 (0.04%)	1
Generalised tonic-clonic seizure ^† 1	1/2677 (0.04%)	1
Hypoaesthesia ^† 1	1/2677 (0.04%)	1
Intracranial aneurysm ^† 1	1/2677 (0.04%)	1
Ischaemic cerebral infarction ^† 1	1/2677 (0.04%)	1
Migraine with aura ^† 1	1/2677 (0.04%)	1
Nerve compression ^† 1	1/2677 (0.04%)	1
Subarachnoid haemorrhage ^† 1	1/2677 (0.04%)	1
Thalamic infarction ^† 1	1/2677 (0.04%)	1
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous ^† 1	3/2677 (0.11%)	3
Abortion threatened ^† 1	1/2677 (0.04%)	1
Haemorrhage in pregnancy ^† 1	1/2677 (0.04%)	1
Premature separation of placenta ^† 1	1/2677 (0.04%)	1
Psychiatric disorders
Depression ^† 1	4/2677 (0.15%)	4
Panic attack ^† 1	2/2677 (0.07%)	2
Alcohol abuse ^† 1	1/2677 (0.04%)	1
Drug abuse ^† 1	1/2677 (0.04%)	1
Emotional distress ^† 1	1/2677 (0.04%)	1
Major depression ^† 1	1/2677 (0.04%)	1
Psychotic disorder ^† 1	1/2677 (0.04%)	1
"Schizophrenia, paranoid type" ^† 1	1/2677 (0.04%)	1
Suicide attempt ^† 1	1/2677 (0.04%)	1
Renal and urinary disorders
Nephrolithiasis ^† 1	3/2677 (0.11%)	5
Calculus ureteric ^† 1	2/2677 (0.07%)	2
Acute kidney injury ^† 1	1/2677 (0.04%)	1
Calculus urethral ^† 1	1/2677 (0.04%)	1
Haematuria ^† 1	1/2677 (0.04%)	1
IgA nephropathy ^† 1	1/2677 (0.04%)	1
Urethral stenosis ^† 1	1/2677 (0.04%)	1
Reproductive system and breast disorders
Endometriosis ^† 1	2/2677 (0.07%)	2
Cervical dysplasia ^† 1	1/2677 (0.04%)	1
Menometrorrhagia ^† 1	1/2677 (0.04%)	1
Ovarian cyst ^† 1	1/2677 (0.04%)	1
Pelvic pain ^† 1	1/2677 (0.04%)	1
Uterine polyp ^† 1	1/2677 (0.04%)	1
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation ^† 1	4/2677 (0.15%)	4
Asthma ^† 1	3/2677 (0.11%)	3
Chronic obstructive pulmonary disease ^† 1	2/2677 (0.07%)	2
Acute respiratory failure ^† 1	1/2677 (0.04%)	1
Choking ^† 1	1/2677 (0.04%)	1
Nasal septum disorder ^† 1	1/2677 (0.04%)	1
Nasal turbinate hypertrophy ^† 1	1/2677 (0.04%)	1
Pneumothorax spontaneous ^† 1	1/2677 (0.04%)	1
Rhinitis allergic ^† 1	1/2677 (0.04%)	1
Status asthmaticus ^† 1	1/2677 (0.04%)	1
Skin and subcutaneous tissue disorders
Dermatitis atopic ^† 1	6/2677 (0.22%)	7
Erythema nodosum ^† 1	2/2677 (0.07%)	2
Actinic keratosis ^† 1	1/2677 (0.04%)	1
Alopecia areata ^† 1	1/2677 (0.04%)	2
Angioedema ^† 1	1/2677 (0.04%)	1
Drug eruption ^† 1	1/2677 (0.04%)	1
Eczema ^† 1	1/2677 (0.04%)	1
Pruritus generalised ^† 1	1/2677 (0.04%)	1
Skin ulcer ^† 1	1/2677 (0.04%)	1
Surgical and medical procedures
Female sterilisation ^† 1	1/2677 (0.04%)	1
Vascular disorders
Deep vein thrombosis ^† 1	3/2677 (0.11%)	3
Aortic aneurysm ^† 1	1/2677 (0.04%)	1
Aortic arteriosclerosis ^† 1	1/2677 (0.04%)	1
Arteriosclerosis ^† 1	1/2677 (0.04%)	1
Hypertension ^† 1	1/2677 (0.04%)	1
Lymphoedema ^† 1	1/2677 (0.04%)	1
Peripheral arterial occlusive disease ^† 1	1/2677 (0.04%)	1
Varicose vein ^† 1	1/2677 (0.04%)	1
1 Term from vocabulary, MedDRA (18.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Dupilumab
	Affected / at Risk (%)	# Events
Total	1613/2677 (60.25%)
Eye disorders
Conjunctivitis allergic ^† 1	242/2677 (9.04%)	329
General disorders
Injection site reaction ^† 1	138/2677 (5.16%)	506
Infections and infestations
Nasopharyngitis ^† 1	774/2677 (28.91%)	1602
Upper respiratory tract infection ^† 1	365/2677 (13.63%)	567
Conjunctivitis ^† 1	277/2677 (10.35%)	417
Oral herpes ^† 1	200/2677 (7.47%)	463
Nervous system disorders
Headache ^† 1	218/2677 (8.14%)	411
Skin and subcutaneous tissue disorders
Dermatitis atopic ^† 1	446/2677 (16.66%)	787
1 Term from vocabulary, MedDRA (18.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

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Name/Title:	Clinical Trials Administrator
Organization:	Regeneron Pharmaceuticals, Inc.
Phone:	1-844-734-6643
EMail:	clinicaltrials@regeneron.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Blauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2023 Jan;40(1):367-380. doi: 10.1007/s12325-022-02322-y. Epub 2022 Nov 1.

Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3.

Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.

Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaci D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29.

Beck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8.

Beck LA, Thaci D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x.

Layout table for additonal information

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01949311
Other Study ID Numbers:	R668-AD-1225 2013-001449-15 ( EudraCT Number )
First Submitted:	September 20, 2013
First Posted:	September 24, 2013
Results First Submitted:	June 23, 2023
Results First Posted:	October 17, 2023
Last Update Posted:	October 17, 2023

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