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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/NCT03100344
Registration number
NCT03100344
Ethics application status
Date submitted
29/03/2017
Date registered
4/04/2017
Date last updated
22/10/2019
Titles & IDs
Public title
Dose-ranging Study of Nemolizumab in Atopic Dermatitis
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Scientific title
Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)
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Secondary ID [1]
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RD.03.SPR.114322
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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 - Nemolizumab
Treatment: Drugs - Placebo
Experimental: Group 1 - Nemolizumab (low dose)
Experimental: Group 2 - Nemolizumab (medium dose)
Experimental: Group 3 - Nemolizumab (high dose)
Placebo Comparator: Group 4 - Nemolizumab placebo
Treatment: Drugs: Nemolizumab
Injection every 4 weeks during 24 weeks (last injection at week 20)
Treatment: Drugs: Placebo
Injection every 4 weeks during 24 weeks (last injection at week 20)
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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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Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
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Assessment method [1]
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EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
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Timepoint [1]
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From Baseline to Week 24
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Secondary outcome [1]
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Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS =1 [None - Mild]) at Week 24
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Assessment method [1]
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The 4-point pruritus categorical scale was provided in their local language for the participants to report the intensity of their pruritus. Overall itching was scored as 0 for absence of pruritus and 3 for severe pruritus (bothersome itching/scratching that disturbs sleep). Higher scores indicate worse outcome.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) =4 at Each Timepoint up to Week 24
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Assessment method [2]
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Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
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Timepoint [2]
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From Week 1 to Week 24
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Secondary outcome [3]
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Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
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Assessment method [3]
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SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
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Assessment method [4]
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SCORAD ranges from 0 to 103 and has three components: extent (body surface area [BSA]), signs, and symptoms of AD. The severity of the 6 signs of AD (erythema/darkening, edema/papulation, oozing/crusting, excoriation, lichenification/prurigo and dryness), was assessed, each on a scale ranging from 0 (none) to 3 (severe).The component of extent corresponded to the extent of BSA affected by atopic dermatitis.The BSA involvement of AD was assessed for each part of the body (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]), and was reported as a percentage of all major body sections combined. Participants were also asked to evaluate their symptoms of pruritus and sleep loss (average for the last 3 days/nights), each evaluated on a Visual analog scale (VAS) from 0 to 10. Higher scores indicate worse outcome.
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Timepoint [4]
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Baseline, Week 24
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Secondary outcome [5]
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Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
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Assessment method [5]
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The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
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Timepoint [5]
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Baseline, Week 24
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Secondary outcome [6]
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Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
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Assessment method [6]
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The sleep disturbance NRS is a scale used by the participants to report the degree of their sleep loss related to AD. Participants were asked the following questions in their local language: how would you rate your sleep last night?: On a scale of 0 to 10, with 0 being 'no sleep loss related to signs/symptoms of AD' and 10 being 'I cannot sleep at all due to the signs/symptoms of AD'. Higher scores indicate worse outcome.
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Timepoint [6]
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Baseline, Week 24
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Secondary outcome [7]
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Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24
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Assessment method [7]
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IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.
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Timepoint [7]
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From Week 1 to Week 24
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Secondary outcome [8]
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Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
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Assessment method [8]
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EASI is a composite score ranging from 0 to 72. The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
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Timepoint [8]
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From Week 1 to Week 24
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Secondary outcome [9]
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Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
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Assessment method [9]
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EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
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Timepoint [9]
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From Week 1 to Week 24
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Secondary outcome [10]
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Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24
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Assessment method [10]
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EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification were assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
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Timepoint [10]
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From Week 1 to Week 24
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Secondary outcome [11]
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Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of =2 Points at Each Visit up to Week 24
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Assessment method [11]
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IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used to evaluate the global severity of AD. Higher scores indicate worse outcome.
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Timepoint [11]
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Week 1 to Week 24
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Secondary outcome [12]
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Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
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Assessment method [12]
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EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
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Timepoint [12]
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From Baseline to Week 24
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Secondary outcome [13]
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Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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Assessment method [13]
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Pruritus NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
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Timepoint [13]
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At baseline and Week 24
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Secondary outcome [14]
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Number of Participants With Adverse Events
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Assessment method [14]
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To evaluate the safety of nemolizumab in participants with moderate-to-severe AD
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Timepoint [14]
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From screening to Follow-up visit (Week 32)/Early termination visit
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Secondary outcome [15]
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Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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Assessment method [15]
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Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For maximum itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
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Timepoint [15]
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Baseline to Week 24
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Secondary outcome [16]
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Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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Assessment method [16]
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Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
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Timepoint [16]
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Baseline to Week 24
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Secondary outcome [17]
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Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
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Assessment method [17]
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0
Pruritus NRS is a scale to be used by the participants to report the intensity of their pruritus (itch) during the last 24 hours. For average itch intensity: the scores were provided on a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable'. Higher scores indicate worse outcome.
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Timepoint [17]
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Baseline to Week 24
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Eligibility
Key inclusion criteria
- Male or female subjects = 18 years (or legal age when higher)
- Chronic AD, that has been present for at least 2 years before the visit
- Eczema Area and Severity Index (EASI) score =12
- Investigator Global Assessment (IGA) score = 3
- AD involvement = 10% of Body Surface Area (BSA)
- Severe pruritus on at least 3 of the last 7 days before the visit
- Documented recent history (within 6 months before the visit) of inadequate response to
topical medications
- Female subjects must fulfill one of the criteria below:
- Female subjects of non-childbearing potential
- Female subjects of childbearing potential who agree to a true abstinence or to
use an effective or highly effective method of contraception throughout the
clinical trial and for 120 days after the last study drug administration
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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
- Body weight < 45 kg
- subjects with a medical history of asthma requiring hospitalization in the last 12
months before screening visit and/or whose asthma has not been well-controlled during
the last 3 months before the screening visit and/or Peak Expiratory Flow (PEF) <80% of
the predicted value
- Cutaneous bacterial or viral infection within 1 week before the screening visit or
during the run-in period
- Infection requiring treatment with oral or parenteral antibiotics, antivirals,
antiparasitics or antifungals within 1 week before the screening visit or during the
run-in period
- History of intolerance to low or mid potency TCS or for whom TCS is not advisable
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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 2
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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
14/06/2017
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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
21/09/2018
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Sample size
Target
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Accrual to date
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Final
226
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Galderma Investigational Site - Benowa
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Recruitment hospital [2]
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Galderma Investigational Site - Kogarah
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Recruitment hospital [3]
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Galderma Investigational Site - Melbourne
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Recruitment hospital [4]
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Galderma Investigational Site - Phillip
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Recruitment postcode(s) [1]
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4217 QLD - Benowa
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Recruitment postcode(s) [2]
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NSW 2217 - Kogarah
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Recruitment postcode(s) [3]
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VIC3002 - Melbourne
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Recruitment postcode(s) [4]
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ACT2606 - Phillip
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Arkansas
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California
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Florida
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Georgia
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Illinois
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Kansas
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Louisiana
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Michigan
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New York
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North Carolina
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Rhode Island
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Texas
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Virginia
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Canada
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Calgary
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Canada
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Markham
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Canada
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Oakville
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Canada
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Ottawa
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Canada
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Peterborough
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Canada
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Richmond Hill
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Canada
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Sainte-Foy
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Canada
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Waterloo
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France
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Bordeaux
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France
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Lille
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France
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Marseille
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France
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Nice
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France
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Paris
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France
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Toulouse
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Berlin
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Darmstadt
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Erlangen
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Frankfurt
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Hamburg
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Germany
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Hannöver
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Germany
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Heidelberg
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Germany
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Langenau
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Germany
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Mainz
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Germany
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München
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Germany
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Osnabrück
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Germany
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Stuttgart
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Poland
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Katowice
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Kraków
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Lublin
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Warsaw
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Wroclaw
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Lódz
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Galderma R&D
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic
dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately
controlled with topical treatments.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03100344
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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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Address
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03100344
Download to PDF