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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04033367
Registration number
NCT04033367
Ethics application status
Date submitted
16/07/2019
Date registered
26/07/2019
Date last updated
2/11/2022
Titles & IDs
Public title
SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"
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Scientific title
A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
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Secondary ID [1]
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2018-004705-26
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Secondary ID [2]
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LPS15497
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - Placebo
Experimental: 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 Comparator: 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.
Treatment: Drugs: Dupilumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Treatment: Drugs: Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [1]
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DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [2]
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DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, Week 12
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Secondary outcome [3]
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DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, Week 12
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Secondary outcome [4]
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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
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 12
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Secondary outcome [5]
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DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline, Week 12
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Secondary outcome [6]
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DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline, Week 12
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Secondary outcome [7]
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DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Week 12
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Secondary outcome [8]
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DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline, Week 12
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Secondary outcome [9]
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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
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline, Week 12
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Secondary outcome [10]
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DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline, Week 12
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Secondary outcome [11]
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DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Week 12
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Secondary outcome [12]
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DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline, Week 12
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Secondary outcome [13]
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DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline up to 14 days after last IMP administration (i.e., up to Week 12)
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Secondary outcome [14]
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Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
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Assessment method [14]
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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).
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Timepoint [14]
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Baseline up to 14 days after last IMP administration (i.e., up to Week 24)
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Eligibility
Key inclusion criteria
Inclusion criteria:
Participants, male or female 18 years or older,
- with diagnosed chronic AD, demonstrated 1) inadequate response to topical medications,
2) expected severity of AD and 3) sleep disturbance.
- had applied skin emollients (moisturizers) at least 7 days before screening.
- had applied medium potency topical corticosteroids (TCS) on all active AD lesions at
least 7 days before screening.
- willed and able to comply with all clinic visits and study-related procedures.
- provided signed informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
Participants excluded from the study:
- with known hypersensitivity to Dupixent, clinical depression, drug abuse history,
sleep problems not related to AD, irregular sleep pattern, active/acute infections,
severe medical conditions, laboratory abnormalities, any condition that might present
unreasonable risk to participants or interfered with study assessment, or any severe
concomitant illness(es) that would adversely affect the participant's participation in
the study, and contraindications of topical corticosteroids.
- at Baseline, presence of any conditions listed as criteria for study drug
discontinuation.
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/10/2021
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Sample size
Target
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Accrual to date
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Final
188
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number :0360006 - Phillip
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Recruitment hospital [2]
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Investigational Site Number :0360001 - Kogarah
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Recruitment hospital [3]
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Investigational Site Number :0360007 - Woolloongabba
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Recruitment hospital [4]
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Investigational Site Number :0360003 - Carlton
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3053 - Carlton
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Recruitment outside Australia
Country [1]
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Oregon
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United States of America
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South Carolina
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France
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Brest
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France
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Nantes
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France
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Paris
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France
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Toulouse
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Germany
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Bad Bentheim
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Germany
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Frankfurt am Main
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Germany
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Friedrichshafen
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Germany
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Göttingen
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Germany
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Münster
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Israel
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Afula
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Israel
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Jerusalem
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Italy
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Milano
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Reggio Calabria
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Italy
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Roma
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Italy
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Siena
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Spain
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Andalucia
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Spain
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Castilla Y León
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Spain
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Valencia
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Sevilla
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Switzerland
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Bern
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United Arab Emirates
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Abu Dhabi
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United Arab Emirates
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Dubai
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United Kingdom
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Birmingham
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United Kingdom
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Edinburgh, City Of
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Regeneron Pharmaceuticals
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Ethics approval
Ethics application status
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Summary
Brief summary
Primary Objective:
To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to
severe atopic dermatitis (AD).
Secondary Objectives:
To evaluate the effect of dupilumab on objective and subjective quantitative sleep
parameters, AD related outcomes, and daytime consequences of sleep deprivation.
To continue to assess the safety and tolerability throughout the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04033367
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Sciences & Operations
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Address
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04033367
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