Trial Outcomes & Findings for Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis (NCT NCT03912259)

NCT ID: NCT03912259

Last Updated: 2023-12-19

Results Overview

The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 165 participants
• Primary outcome timeframe: Baseline, Week 16
• Results posted on: 2023-12-19

Participant Flow

The study was conducted at 25 active centers in China between 19 Dec 2018 and 14 Feb 2020. A total of 165 participants were randomized and treated in the study.

Participants were randomized in a 1:1 ratio to dupilumab or placebo according to a central randomization scheme provided by an interactive response technology.

Participant milestones

Measure	Placebo Q2W Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.	Dupilumab 300 mg Q2W Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Overall Study STARTED	83	82
Overall Study COMPLETED	66	76
Overall Study NOT COMPLETED	17	6

Reasons for withdrawal

Measure	Placebo Q2W Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.	Dupilumab 300 mg Q2W Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Overall Study Adverse Event (AE)	2	4
Overall Study Lack of Efficacy	4	1
Overall Study Withdrawal by Subject	11	1

Baseline Characteristics

Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis

Baseline characteristics by cohort

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.	Total n=165 Participants Total of all reporting groups
Age, Continuous	30.2 years STANDARD_DEVIATION 12.46 • n=5 Participants	31.0 years STANDARD_DEVIATION 10.47 • n=7 Participants	30.6 years STANDARD_DEVIATION 11.49 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	83 Participants n=5 Participants	82 Participants n=7 Participants	165 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Investigator's Global Assessment (IGA) Score IGA = 3	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Investigator's Global Assessment (IGA) Score IGA = 4	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16	4 Participants	22 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

EASI: Measure to assess severity and extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] and lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) and scored separately for each of 4 body regions (head, trunk, upper and lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 16	12 Participants	47 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants Who Achieved >=4 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 16	4 Participants	32 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants Who Achieved >=3 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale Score at Week 16	8 Participants	43 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS	-21.13 percentage change Standard Error 3.610	-48.59 percentage change Standard Error 3.026

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS	-1.64 units on a scale Standard Error 0.272	-3.84 units on a scale Standard Error 0.237

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

EASI: Measure to assess severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3"(severe) & scored separately for each of 4 body regions (head, trunk, upper & lower extremities). Total score ranges from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change From Baseline to Week 16 in EASI Score	-39.44 percentage change Standard Error 4.936	-75.23 percentage change Standard Error 3.879

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

BSA affected by AD was assessed for each section of the body (the possible highest score for each region was: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and reported as a percentage of all major body sections combined. The reported percentage of BSA was combined percentage of all major body sections.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement	-19.25 percentage of body surface area Standard Error 2.557	-37.76 percentage of body surface area Standard Error 2.126

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The DLQI was a validated questionnaire used to measure the impact of AD disease symptoms and treatment on health-related quality of life (QOL). DLQI consisting of a set of 10 questions which assess QOL over the past week. Responses to each questions were assessed on a scale of 0 to 3, where 0 is "not at all" and 3 is "very much". Scores from all 10 questions added up to give total DLQI scores ranged from 0 (not at all) to 30 (very much), higher scores indicated more impact on quality of life.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score	-5.06 units on a scale Standard Error 0.701	-10.33 units on a scale Standard Error 0.625

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a scale ranging from 0 to 4 (0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, 4 = all days). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (severe disease). Higher scores indicated more severe disease and poor quality of life.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM)	-4.04 units on a scale Standard Error 0.788	-12.89 units on a scale Standard Error 0.685

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change From Baseline to Week 2 in Weekly Average of Peak Daily Pruritus NRS	-4.75 percentage change Standard Error 1.802	-15.65 percentage change Standard Error 1.818

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The EQ-5D is a standardized measure of health status which is consists of 2 parts; the descriptive system and the EQ visual analogue scale (EQVAS). The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score between 0 to 1 that quantify health status, where 0 represents "death" and 1 represents "perfect health".

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire (EQ-5D) Index Scores	2.92 percentage change Standard Error 0.692	8.00 percentage change Standard Error 0.562

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analogue scale ranged from 0-100 where 100 indicated "best imaginable health state" and 0 indicated "worst imaginable health state", higher scores indicated better outcome.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores	60.19 percentage change Standard Error 25.154	90.32 percentage change Standard Error 24.775

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The EQ-5D is a standardized measure of health status which consisted of 2 parts; the descriptive system and the EQVAS. The EQ-5D descriptive system includes 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension measured on 3 levels: "no problem" (level 1), "some problems" (level 2), "extreme problems" (level 3). The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state. The 5 dimensional 3-level systems was converted into single index utility score between 0 to 1 that quantify health status, where 0 represents "death" and 1 represents "perfect health".

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Absolute Change From Baseline to Week 16 in EQ-5D Index Scores	0.02 units on a scale Standard Error 0.006	0.06 units on a scale Standard Error 0.004

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The EQ-5D VAS records the respondent's self-rated health on a vertical, visual analogue scale ranged from 0-100 where 100 indicated "best imaginable health state" and 0 indicated "worst imaginable health state", higher scores indicated better outcome.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Absolute Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores	10.75 units on a scale Standard Error 2.689	18.22 units on a scale Standard Error 2.243

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: Analysis was performed on ITT population.

The IGA is an assessment instrument used to rate the severity of AD globally, based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity. In this outcome measure, number of participants who achieved reduction from baseline of >=2 points in IGA score at Week 16 were reported.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants Who Achieve Reduction of IGA Score by >=2 From Baseline to Week 16	7 Participants	39 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Analysis was performed on ITT population.

The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16 Week 8	0 Participants	9 Participants
Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16 Week 2	0 Participants	2 Participants
Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16 Week 4	0 Participants	6 Participants
Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16 Week 12	4 Participants	16 Participants
Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16 Week 16	4 Participants	22 Participants

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Analysis was performed on ITT population.

EASI: Measure to assess severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) & scored separately for each of 4 body regions (head, trunk, upper & lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD. Participants with missing EASI Score at each visit were imputed using MI (Multiple Imputation) method.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 2	-3.27 units on a scale Standard Deviation 7.974	-12.48 units on a scale Standard Deviation 12.640
Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 4	-6.45 units on a scale Standard Deviation 11.838	-19.56 units on a scale Standard Deviation 13.687
Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 8	-9.54 units on a scale Standard Deviation 10.947	-22.45 units on a scale Standard Deviation 12.830
Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 12	-11.23 units on a scale Standard Deviation 12.603	-24.32 units on a scale Standard Deviation 14.191
Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 16	-12.60 units on a scale Standard Deviation 12.484	-25.87 units on a scale Standard Deviation 13.985

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16

Population: Analysis was performed on ITT population.

EASI: Measure to assess severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) & scored separately for each of 4 body regions (head, trunk, upper & lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 2	-10.55 percentage change Standard Error 2.977	-35.69 percentage change Standard Error 2.930
Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 4	-19.28 percentage change Standard Error 3.981	-55.83 percentage change Standard Error 3.684
Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 8	-29.38 percentage change Standard Error 4.147	-65.84 percentage change Standard Error 3.562
Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 12	-35.26 percentage change Standard Error 4.674	-70.36 percentage change Standard Error 4.047
Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Week 16	-39.44 percentage change Standard Error 4.936	-75.23 percentage change Standard Error 3.879

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

EASI: Measure to assess severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) & scored separately for each of 4 body regions (head, trunk, upper & lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16	24 Participants	58 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: Analysis was performed on ITT population.

EASI: Measure to assess severity & extent of AD based on 4 AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation] & lichenification). Each characteristic was assessed for severity by Investigator/designee on scale of "0" (absent) through "3" (severe) & scored separately for each of 4 body regions (head, trunk, upper & lower extremities). Total score range from 0 (minimum) to 72 (maximum), higher scores indicated greater severity of AD.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16	5 Participants	33 Participants

SECONDARY outcome

Timeframe: From Baseline Through Week 16

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. Participants with missing Peak Daily Pruritus NRS Score at each visit were imputed using MI method.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 1	-0.26 units on a scale Standard Error 0.106	-0.63 units on a scale Standard Error 0.107
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 2	-0.38 units on a scale Standard Error 0.135	-1.26 units on a scale Standard Error 0.136
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 3	-0.61 units on a scale Standard Error 0.153	-1.90 units on a scale Standard Error 0.153
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 4	-0.69 units on a scale Standard Error 0.162	-2.26 units on a scale Standard Error 0.159
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 5	-0.88 units on a scale Standard Error 0.191	-2.61 units on a scale Standard Error 0.187
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 6	-0.96 units on a scale Standard Error 0.205	-2.81 units on a scale Standard Error 0.201
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 7	-0.88 units on a scale Standard Error 0.214	-3.14 units on a scale Standard Error 0.208
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 8	-1.04 units on a scale Standard Error 0.212	-3.21 units on a scale Standard Error 0.205
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 9	-1.10 units on a scale Standard Error 0.218	-3.29 units on a scale Standard Error 0.209
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 10	-1.12 units on a scale Standard Error 0.221	-3.38 units on a scale Standard Error 0.210
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 11	-1.24 units on a scale Standard Error 0.231	-3.52 units on a scale Standard Error 0.216
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 12	-1.34 units on a scale Standard Error 0.233	-3.59 units on a scale Standard Error 0.213
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 13	-1.46 units on a scale Standard Error 0.246	-3.65 units on a scale Standard Error 0.223
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 14	-1.53 units on a scale Standard Error 0.264	-3.71 units on a scale Standard Error 0.241
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 15	-1.56 units on a scale Standard Error 0.262	-3.81 units on a scale Standard Error 0.234
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 16	-1.64 units on a scale Standard Error 0.272	-3.84 units on a scale Standard Error 0.237

SECONDARY outcome

Timeframe: From Baseline Through Week 16

Population: Analysis was performed on ITT population.

Pruritus NRS was an assessment tool that was used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period. Participants were asked the following question: how would a participant rate his itch at the worst moment during the previous 24 hours (for maximum itch intensity on a scale of 0 - 10 [0 = no itch; 10 = worst itch imaginable]), higher scores indicated greater severity. Participants with missing peak NRS scores at each visit were imputed using MI method.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 12	-17.07 percentage change Standard Error 3.048	-45.37 percentage change Standard Error 2.735
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 13	-18.80 percentage change Standard Error 3.235	-46.15 percentage change Standard Error 2.845
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 14	-19.63 percentage change Standard Error 3.501	-47.04 percentage change Standard Error 3.061
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 15	-19.96 percentage change Standard Error 3.503	-48.29 percentage change Standard Error 3.009
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 16	-21.13 percentage change Standard Error 3.610	-48.59 percentage change Standard Error 3.026
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 1	-2.95 percentage change Standard Error 1.387	-7.30 percentage change Standard Error 1.405
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 2	-4.75 percentage change Standard Error 1.802	-15.65 percentage change Standard Error 1.818
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 3	-7.92 percentage change Standard Error 2.000	-23.66 percentage change Standard Error 1.988
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 4	-9.10 percentage change Standard Error 2.118	-28.17 percentage change Standard Error 2.069
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 5	-11.56 percentage change Standard Error 2.477	-32.65 percentage change Standard Error 2.410
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 6	-12.41 percentage change Standard Error 2.623	-35.01 percentage change Standard Error 2.543
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 7	-11.37 percentage change Standard Error 2.743	-39.16 percentage change Standard Error 2.642
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 8	-13.22 percentage change Standard Error 2.710	-40.36 percentage change Standard Error 2.594
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 9	-14.03 percentage change Standard Error 2.796	-41.28 percentage change Standard Error 2.655
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 10	-14.24 percentage change Standard Error 2.857	-42.51 percentage change Standard Error 2.682
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 Week 11	-15.72 percentage change Standard Error 2.972	-44.26 percentage change Standard Error 2.746

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on ITT population.

The pruritus categorical scale was a 4-point scale used to assess symptoms of AD. The scale is rated as follows: 0: absence of pruritus; 1: mild pruritus (occasional slight itching/scratching); 2: moderate pruritus (constant or intermittent itching/scratching that does not disturb sleep) and 3: severe pruritus (bothersome itching/scratching that disturbs sleep), higher scores indicated worse outcome.

Outcome measures

Measure	Placebo Q2W n=83 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Participants Who Responded "Absence of Pruritus" or "Mild Pruritus" in the Pruritus Categorical Scale at Week 16	12 Participants	49 Participants

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' represent the number of participants analyzed for each specified row.

Participants who were employed or enrolled in school for full time were asked to report the number of sick leave/missed school days since the last study assessment. Participants were counted as Full time if the participant checked "Full time" at all visits through 16-week treatment period and participants were counted as Part time if the participant checked at least one "Part time" during 16-week treatment period.

Outcome measures

Measure	Placebo Q2W n=58 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=66 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Number of Days of Sick Leave/Missed School Days Full time	0.66 Days Standard Deviation 2.075	0.88 Days Standard Deviation 3.468
Number of Days of Sick Leave/Missed School Days Part time	11.14 Days Standard Deviation 20.923	7.44 Days Standard Deviation 9.202

SECONDARY outcome

Timeframe: Week 16

Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure and 'number analyzed' represent the number of participants analyzed for each specified row.

Participants who were employed or enrolled in school for full time were asked to report the number of sick leave/missed school days since the last study assessment. Participants were counted as Full time if the participant checked "Full time" at all visits through 16-week treatment period and participants were counted as Part time if the participant checked at least one "Part time" during 16-week treatment period.

Outcome measures

Measure	Placebo Q2W n=58 Participants Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=66 Participants Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Percentage of Participants With at Least One Day Sick Leave/Missed School Days Full time	14.9 percentage of participants	22.4 percentage of participants
Percentage of Participants With at Least One Day Sick Leave/Missed School Days Part time	72.7 percentage of participants	75.0 percentage of participants

Adverse Events

Placebo Q2W

Serious events: 4 serious events

Other events: 57 other events

Deaths: 0 deaths

Dupilumab 300 mg Q2W

Serious events: 1 serious events

Other events: 56 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo Q2W n=83 participants at risk Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 participants at risk Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Immune system disorders Anaphylactic Reaction	1.2% 1/83 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	0.00% 0/82 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Musculoskeletal and connective tissue disorders Connective Tissue Disorder	1.2% 1/83 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	0.00% 0/82 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.00% 0/83 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	1.2% 1/82 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Respiratory, thoracic and mediastinal disorders Asthma	1.2% 1/83 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	0.00% 0/82 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Skin and subcutaneous tissue disorders Dermatitis Atopic	1.2% 1/83 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	0.00% 0/82 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).

Other adverse events

Measure	Placebo Q2W n=83 participants at risk Placebo matched to dupilumab 600 mg (loading dose), SC on Day 1 followed by placebo matched to dupilumab 300 mg, Q2W for 16 weeks.	Dupilumab 300 mg Q2W n=82 participants at risk Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
Eye disorders Conjunctivitis Allergic	1.2% 1/83 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	8.5% 7/82 • Number of events 7 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Gastrointestinal disorders Diarrhoea	2.4% 2/83 • Number of events 2 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	6.1% 5/82 • Number of events 5 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Infections and infestations Conjunctivitis	4.8% 4/83 • Number of events 4 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	9.8% 8/82 • Number of events 8 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Infections and infestations Folliculitis	7.2% 6/83 • Number of events 6 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	1.2% 1/82 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Infections and infestations Nasopharyngitis	2.4% 2/83 • Number of events 2 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	7.3% 6/82 • Number of events 8 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Infections and infestations Upper Respiratory Tract Infection	12.0% 10/83 • Number of events 13 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	17.1% 14/82 • Number of events 16 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Investigations Blood Uric Acid Increased	6.0% 5/83 • Number of events 6 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	1.2% 1/82 • Number of events 1 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Investigations Protein Urine Present	10.8% 9/83 • Number of events 9 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	11.0% 9/82 • Number of events 10 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).
Skin and subcutaneous tissue disorders Dermatitis Atopic	49.4% 41/83 • Number of events 54 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).	43.9% 36/82 • Number of events 51 • All AEs were collected from signature of the informed consent form up to end of study regardless of seriousness or relationship to investigational product. Time frame for reporting of treatment emergent adverse events (TEAEs) was from first dose up to 28 weeks. TEAEs are defined as AEs that developed or worsened during the treatment-emergent period. Safety population included all randomized participants received any investigational medicinal product (IMP). Participants were analyzed according to the treatment they actually received (as treated).

Additional Information

Trial Transparency Team

Sanofi

Phone: 800-633-1610

Email: Contact-US@sanofi.com

Results disclosure agreements

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Restriction type: OTHER