Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03912259
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).
Secondary Objectives:
* To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD.
* To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
* To evaluate dupilumab immunogenicity.
- Detailed Description
The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Q2W Emollient (moisturizer) 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 Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks. Dupilumab 300 mg Q2W Emollient (moisturizer) Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks. Placebo Q2W Placebo 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.
- Primary Outcome Measures
Name Time Method 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 Baseline, Week 16 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement Baseline to Week 16 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.
Absolute Change From Baseline to Week 16 in EQ-5D Index Scores Baseline to Week 16 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".
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 16 Baseline, Week 16 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.
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 Baseline, Week 16 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.
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 Baseline, Week 16 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.
Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores Baseline to Week 16 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.
Absolute Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores Baseline to Week 16 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.
Number of Participants Who Achieve Reduction of IGA Score by >=2 From Baseline to Week 16 Baseline to Week 16 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.
Percentage Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS Baseline, Week 16 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.
Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS Baseline, Week 16 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.
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score Baseline to Week 16 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.
Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM) Baseline to Week 16 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.
Percentage Change From Baseline to Week 2 in Weekly Average of Peak Daily Pruritus NRS Baseline to Week 2 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.
Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire (EQ-5D) Index Scores Baseline to Week 16 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".
Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16 Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 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.
Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16 Baseline, Week 16 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.
Percentage Change From Baseline to Week 16 in EASI Score Baseline to Week 16 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.
Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 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.
Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16 Baseline, Week 16 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.
Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16 Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 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.
Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 From Baseline Through Week 16 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.
Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16 From Baseline Through Week 16 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.
Number of Participants Who Responded "Absence of Pruritus" or "Mild Pruritus" in the Pruritus Categorical Scale at Week 16 Week 16 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.
Percentage of Participants With at Least One Day Sick Leave/Missed School Days Week 16 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.
Number of Days of Sick Leave/Missed School Days Week 16 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.
Trial Locations
- Locations (27)
Investigational Site Number 1560006
🇨🇳Changsha, China
Investigational Site Number 1560030
🇨🇳Lianyungang, China
Investigational Site Number 1560021
🇨🇳Changchun, China
Investigational Site Number 1560019
🇨🇳Beijing, China
Investigational Site Number 1560023
🇨🇳Shanghai, China
Investigational Site Number 1560018
🇨🇳Shanghai, China
Investigational Site Number 1560008
🇨🇳Shenyang, China
Investigational Site Number 1560003
🇨🇳Beijing, China
Investigational Site Number 1560012
🇨🇳Xi'An, China
Investigational Site Number 1560025
🇨🇳Yancheng, China
Investigational Site Number 1560001
🇨🇳Beijing, China
Investigational Site Number 1560004
🇨🇳Beijing, China
Investigational Site Number 1560026
🇨🇳Hangzhou, China
Investigational Site Number 1560010
🇨🇳Beijing, China
Investigational Site Number 1560017
🇨🇳Chongqing, China
Investigational Site Number 1560007
🇨🇳Hangzhou, China
Investigational Site Number 1560013
🇨🇳Jinan, China
Investigational Site Number 1560020
🇨🇳Kunming, China
Investigational Site Number 1560029
🇨🇳Ningbo, China
Investigational Site Number 1560016
🇨🇳Shanghai, China
Investigational Site Number 1560015
🇨🇳Shanghai, China
Investigational Site Number 1560002
🇨🇳Shenyang, China
Investigational Site Number 1560005
🇨🇳Shenyang, China
Investigational Site Number 1560028
🇨🇳Wuxi, China
Investigational Site Number 1560024
🇨🇳Shenzhen, China
Investigational Site Number 1560027
🇨🇳Tianjin, China
Investigational Site Number 1560022
🇨🇳Nanjing, China