Trial Outcomes & Findings for SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients" (NCT NCT04033367)
NCT ID: NCT04033367
Last Updated: 2025-09-17
Results Overview
Sleep quality NRS was used to assess the quality of the participant's previous night's sleep. It was collected on a 11-point scale ranged from 0 (worst possible sleep) to 10 (best possible sleep), where higher score indicated better outcome. Percent change from Baseline in sleep quality NRS at Week 12 was reported in this outcome measure.
COMPLETED
PHASE4
188 participants
Baseline, Week 12
2025-09-17
Participant Flow
Study was conducted at 46 centers in 10 countries. A total of 267 participants were screened between 22 August 2019 and 13 April 2021, of which 188 participants were enrolled and randomized. A total of 79 participants failed screening mainly due to not meeting eligibility criteria.
Participants were randomly assigned to receive either dupilumab or placebo in a 2:1 ratio via interactive voice response system.
Participant milestones
| Measure |
Dupilumab/Dupilumab
Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
|
Placebo/Dupilumab
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
|
|---|---|---|
|
DB Period (Up to Week 12)
STARTED
|
127
|
61
|
|
DB Period (Up to Week 12)
COMPLETED
|
122
|
60
|
|
DB Period (Up to Week 12)
NOT COMPLETED
|
5
|
1
|
|
OLE Period (Week 12 to Week 24)
STARTED
|
122
|
60
|
|
OLE Period (Week 12 to Week 24)
COMPLETED
|
117
|
59
|
|
OLE Period (Week 12 to Week 24)
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Dupilumab/Dupilumab
Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
|
Placebo/Dupilumab
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
|
|---|---|---|
|
DB Period (Up to Week 12)
Adverse Event
|
1
|
1
|
|
DB Period (Up to Week 12)
Withdrawal by Subject
|
4
|
0
|
|
OLE Period (Week 12 to Week 24)
Withdrawal by Subject
|
4
|
1
|
|
OLE Period (Week 12 to Week 24)
Other-unspecified
|
1
|
0
|
Baseline Characteristics
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
Baseline characteristics by cohort
| Measure |
Dupilumab/Dupilumab
n=127 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
|
Placebo/Dupilumab
n=61 Participants
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 14.68 • n=93 Participants
|
34.5 years
STANDARD_DEVIATION 15.36 • n=4 Participants
|
35.7 years
STANDARD_DEVIATION 14.89 • n=27 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on modified intent-to-treat (mITT) analysis set which included all randomized participants with a treatment kit number allocated and recorded in the IRT database, regardless of whether the treatment kit was used or not, who had a Baseline and at least one post-baseline measurement. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Sleep quality NRS was used to assess the quality of the participant's previous night's sleep. It was collected on a 11-point scale ranged from 0 (worst possible sleep) to 10 (best possible sleep), where higher score indicated better outcome. Percent change from Baseline in sleep quality NRS at Week 12 was reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Dupilumab
n=122 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=60 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
|
-47.71 percent change
Standard Deviation 27.240
|
-32.98 percent change
Standard Deviation 29.536
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
Peak Pruritus NRS was an assessment tool that was used by participants to report the intensity of their pruritus (itch) during a 24-hour recall period. Participants were asked the following question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?". Participants answered the question at the specified time point (for the last 24 hours) on the scale of 0 (no itch) to 10 (worst itch imaginable), where higher scores indicated greater severity.
Outcome measures
| Measure |
DB Period: Dupilumab
n=110 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=48 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12
|
-52.45 percent change
Standard Deviation 30.614
|
-23.29 percent change
Standard Deviation 30.075
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
SCORAD is a validated scoring index for AD, which consists of 3 components i.e., A =extent or affected body surface area (BSA) assessed as a percentage of each defined body area and reported as the sum of all areas, with a maximum score of 100%. B=severity of 6 specific symptoms of AD (redness, swelling, oozing/crusting, excoriation, skin thickening/lichenification, dryness) assessed using the following scale: none (0), mild (1), moderate (2), or severe (3) (for a maximum of 18 total points) and C=subjective symptoms scored by participants on VAS, where "0" is no itch (or no sleeplessness) and "10" is the worst imaginable itch (or sleeplessness) with a maximum score of 20. SCORAD total score was calculated using these 3 aspects: extent (A: 0-100), severity (B: 0-18), and subjective symptoms (C: 0-20) using the formula: A/5 + 7\*B/2+ C to give the SCORAD total score range of 0 to 103, where 0 = no disease to 103 = severe disease. Higher values of SCORAD represent worse outcome.
Outcome measures
| Measure |
DB Period: Dupilumab
n=109 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=48 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12
|
-37.78 score on a scale
Standard Deviation 17.743
|
-20.55 score on a scale
Standard Deviation 17.944
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
SCORAD is a validated scoring index for AD, which combines extent (A, 0-100), severity (B, 0-18), and subjective symptoms (C, 0-20) based on itch and sleeplessness, each scored (0-10). The SCORAD for an individual was calculated by the formula: A/5 + 7B/2 + C (can range from 0 to 103). Subjective symptoms (i.e., itch and sleeplessness/sleep loss) were each scored by the participant using a VAS ranging from 0 to 10, where "0" is no itch (or no sleep loss) and "10" is the worst imaginable itch (or sleeplessness). Change from Baseline in SCORAD sleeplessness/sleep loss VAS score is reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Dupilumab
n=108 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=47 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12
|
-4.85 score on a scale
Standard Deviation 2.953
|
-2.31 score on a scale
Standard Deviation 3.024
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
PROMIS is a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Level 2, sleep disturbance measure. In this study, 8- item PROMIS Sleep Related Impairment SF8a that assesses the domain of sleep related impairment in the past 7 days in individuals aged 18 and older, was used. Each item asks the participant to rate the severity of the participant's sleep related impairment during the past 7 days (at each specified visit) on a 5-point scale (1 = not at all; 2 = a little bit; 3 = somewhat; 4 = quite a bit; and 5 = very much) with raw score ranging from 8 to 40; higher scores indicating greater severity of sleep impairment. PROMIS T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. Possible range for T-score is 30 to 80, with higher scores indicating greater severity of sleep impairment.
Outcome measures
| Measure |
DB Period: Dupilumab
n=103 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=54 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a (SF8a) Total T-Score at Week 12
|
-11.42 T-score
Standard Deviation 6.710
|
-7.77 T-score
Standard Deviation 7.240
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. TST (in minutes) was calculated using the formula: Time of waking up for the day minus time of falling sleep minus Wake After Sleep Onset (WASO), where WASO = time awake after initial sleep onset but before the final awakening for the day. Data for WASO was collected from Question 3 of the Sleep Diary: "Considering all the times you woke up last night, how much time were you awake in total?". Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in TST at Week 12 is reported.
Outcome measures
| Measure |
DB Period: Dupilumab
n=108 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=47 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12
|
9.00 minutes
Standard Deviation 70.987
|
-6.36 minutes
Standard Deviation 55.620
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. SE was calculated using the formula: (TST divided by \[Time of waking up for the day - Time of trying to fall sleep\]) multiplied by 100 percent (%). TST (in minutes) was calculated using the formula: Time of waking up for the day minus time of falling sleep minus Wake After Sleep Onset (WASO), where WASO = time awake after initial sleep onset but before the final awakening for the day. Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in SE at Week 12 is reported.
Outcome measures
| Measure |
DB Period: Dupilumab
n=108 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=47 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12
|
1.81 percentage of time in bed spent asleep
Standard Deviation 6.593
|
1.53 percentage of time in bed spent asleep
Standard Deviation 6.018
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. WASO = time awake (in minutes) after initial sleep onset but before the final awakening for the day. Data for WASO was collected from Question 3 of the Sleep Diary: "Considering all the times you woke up last night, how much time were you awake in total?". Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in WASO at Week 12 is reported.
Outcome measures
| Measure |
DB Period: Dupilumab
n=108 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=47 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12
|
-6.79 minutes
Standard Deviation 22.786
|
-9.19 minutes
Standard Deviation 24.661
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
A sleep diary was designed to gather information about participant's daily sleep pattern. It measured night-time sleep assessments. SOL (in minutes) was calculated using the formula: Time of falling sleep - Time of trying to fall sleep. Baseline and Post-baseline weekly average data were calculated based on the mean of the data over the 7 days prior to and including the day at the Baseline or at the end of the corresponding week. In this outcome measure, change from Baseline in SOL at Week 12 is reported.
Outcome measures
| Measure |
DB Period: Dupilumab
n=108 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=47 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12
|
-1.44 minutes
Standard Deviation 19.983
|
-3.37 minutes
Standard Deviation 21.477
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Percentage of participants with EASI-50 (\>=50% improvement from Baseline in EASI score) at Week 12 is reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Dupilumab
n=109 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=48 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Percentage of Participants With Eczema Area Severity Index-50 (EASI-50) (Greater Than or Equal to [>=] 50% Improvement From Baseline) at Week 12
|
89.0 percentage of participants
|
58.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
EASI evaluates severity of participants with AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\] and lower limbs \[including buttocks\]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each body region: 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), and 6 (90% to 100%). Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. Percentage of participants with EASI-75 (\>=75% improvement from Baseline in EASI score) at Week 12 is reported in this outcome measure.
Outcome measures
| Measure |
DB Period: Dupilumab
n=109 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=48 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12
|
60.6 percentage of participants
|
29.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
The POEM was a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults with AD. The format is participant response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (i.e., 0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day'). 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 |
DB Period: Dupilumab
n=90 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=39 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12
|
-13.63 score on a scale
Standard Deviation 7.496
|
-4.44 score on a scale
Standard Deviation 6.824
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Analysis was performed on mITT set. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.
DLQI was a 10-item questionnaire that measures the impact of skin disease. Each question was evaluated on a 4-point scale ranged from 0 to 3 where, 0 = not at all, 1= a little, 2= a lot, 3= very much, where higher scores indicated more impact on quality of life. Scores from all 10 questions were added up to give DLQI total score range from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of participants.
Outcome measures
| Measure |
DB Period: Dupilumab
n=90 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=39 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
|
-11.82 score on a scale
Standard Deviation 6.503
|
-7.54 score on a scale
Standard Deviation 6.801
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last IMP administration (i.e., up to Week 12)Population: Analysis was performed on safety analysis set (SAS) which included all randomized participants who actually received at least 1 dose or partial dose of the IMP and analyzed according to the treatment actually received.
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (from the first investigational medicinal product \[IMP\] administration to the last IMP administration + 14 days) in DB period.
Outcome measures
| Measure |
DB Period: Dupilumab
n=127 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=61 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TEAEs
|
72 Participants
|
41 Participants
|
|
DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TESAEs
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 14 days after last IMP administration (i.e., up to Week 24)Population: Analysis was performed on SAS.
An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. SAEs were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (from the first IMP administration to the last IMP administration + 14 days).
Outcome measures
| Measure |
DB Period: Dupilumab
n=127 Participants
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
DB Period: Placebo
n=61 Participants
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
|---|---|---|
|
Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TEAEs
|
89 Participants
|
46 Participants
|
|
Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Any TESAEs
|
3 Participants
|
1 Participants
|
Adverse Events
DB Period: Placebo
DB Period: Dupilumab
OLE Period: Placebo/Dupilumab
OLE Period: Dupilumab/Dupilumab
Serious adverse events
| Measure |
DB Period: Placebo
n=61 participants at risk
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
DB Period: Dupilumab
n=127 participants at risk
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
OLE Period: Placebo/Dupilumab
n=60 participants at risk
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
|
OLE Period: Dupilumab/Dupilumab
n=122 participants at risk
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
|
|---|---|---|---|---|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/61 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.79%
1/127 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/60 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/122 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/61 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/127 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/60 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.82%
1/122 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/61 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/127 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/60 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.82%
1/122 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/61 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.79%
1/127 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/60 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/122 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma
|
1.6%
1/61 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/127 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/60 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.00%
0/122 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
Other adverse events
| Measure |
DB Period: Placebo
n=61 participants at risk
Participants received placebo matching to dupilumab injection SC on day 1 then followed by placebo injection SC q2w up to Week 10.
|
DB Period: Dupilumab
n=127 participants at risk
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10.
|
OLE Period: Placebo/Dupilumab
n=60 participants at risk
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
|
OLE Period: Dupilumab/Dupilumab
n=122 participants at risk
Participants received dupilumab 600 mg (loading dose) injection SC on Day 1 followed by dupilumab 300 mg injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
|
|---|---|---|---|---|
|
Infections and infestations
Conjunctivitis
|
4.9%
3/61 • Number of events 3 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
9.4%
12/127 • Number of events 12 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
11.7%
7/60 • Number of events 7 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
2.5%
3/122 • Number of events 3 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Infections and infestations
Nasopharyngitis
|
4.9%
3/61 • Number of events 3 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
1.6%
2/127 • Number of events 2 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
6.7%
4/60 • Number of events 4 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
1.6%
2/122 • Number of events 2 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/61 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
0.79%
1/127 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
10.0%
6/60 • Number of events 6 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
12.3%
15/122 • Number of events 15 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Nervous system disorders
Headache
|
8.2%
5/61 • Number of events 5 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
7.1%
9/127 • Number of events 10 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
5.0%
3/60 • Number of events 3 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
1.6%
2/122 • Number of events 2 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
13.1%
8/61 • Number of events 10 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
3.1%
4/127 • Number of events 6 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
1.7%
1/60 • Number of events 1 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
2.5%
3/122 • Number of events 4 • From the first IMP administration up to Week 12 (for DB period arms) and from first IMP administration in OLE period up to Week 24 (for OLE period arms)
Reported AEs were TEAEs that occurred/worsened in grade or became serious during TEAE period (defined as the time from the first IMP administration in DB period to the last IMP administration in OLE period + 14 days). Analysis was performed on SAS.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER