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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03985943
Registration number
NCT03985943
Ethics application status
Date submitted
11/06/2019
Date registered
14/06/2019
Titles & IDs
Public title
Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis
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Secondary ID [1]
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RD.06.SPR.118161
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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:
Moderate-to-Severe 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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0
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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 - Placebo
Treatment: Drugs - Nemolizumab
Placebo comparator: Placebo - Placebo
Experimental: Nemolizumab - Nemolizumab Active
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: Nemolizumab
Nemolizumab
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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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Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a More Than Equal to [>=] 2-point Reduction): Intent-To-Treat (ITT) Population
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Assessment method [1]
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IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of atopic dermatitis (AD) and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population
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Assessment method [2]
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IGA success was defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline to Week 16. The IGA is a 5-point scale ranging from 0 (clear) to 4 (severe) used by the Investigator or trained designee to evaluate the global severity of AD and the clinical response to treatment. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered a treatment failure. Participants with missing data at Week 16 were considered non-responders.
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Timepoint [2]
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Week 16
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Primary outcome [3]
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Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
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Assessment method [3]
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EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD 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 \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.
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Timepoint [3]
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Week 16
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Primary outcome [4]
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Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population
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Assessment method [4]
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EASI-75 was defined as \>=75 percent(%) improvement in EASI from baseline to Week 16. EASI evaluates severity of participants AD 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 \& neck, upper limbs, trunk \& lower limbs on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data at Week 16 were considered non-responders. EASI total score is composite score ranging from 0 to 72. Higher scores represent greater severity of AD.
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Timepoint [4]
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Week 16
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Secondary outcome [1]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
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Assessment method [1]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.
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Timepoint [1]
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Week 16
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Secondary outcome [2]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
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Assessment method [2]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
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Assessment method [3]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
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Assessment method [4]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
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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 question 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'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [5]
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Week 16
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Secondary outcome [6]
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Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
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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 question 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'. Weekly average SD NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
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Assessment method [7]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [7]
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Week 4
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Secondary outcome [8]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
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Assessment method [8]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [8]
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Week 4
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Secondary outcome [9]
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Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
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Assessment method [9]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [9]
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Week 4
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Secondary outcome [10]
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Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
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Assessment method [10]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [10]
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Week 4
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Secondary outcome [11]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
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Assessment method [11]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [11]
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Week 2
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Secondary outcome [12]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
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Assessment method [12]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [12]
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Week 2
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Secondary outcome [13]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
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Assessment method [13]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [13]
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Week 1
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Secondary outcome [14]
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Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
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Assessment method [14]
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The PP NRS is a scale that was used by the participants to report the intensity of their pruritus (itch) during the last 24 hours on a scale of 0 to 10, with 0 being 'no itch' and 10 being the 'worst itch imaginable'. Weekly average PP NRS score was calculated using 7 consecutive days diary data and set to missing if less than 4 days data available. If a participant received any rescue therapy, the data after receipt of rescue therapy was considered treatment failure. Participants with missing data were considered non-responders.
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Timepoint [14]
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Week 1
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Eligibility
Key inclusion criteria
Key
* Male or female subjects aged greater than and equal to (>=) 12 years at the screening visit.
* Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for at least 2 years before the screening visit.
* Eczema Area and Severity Index (EASI) score >=16 at the screening and baseline visits.
* Investigator Global Assessment (IGA) score >= 3 (scale of 0 to 4) at the screening and baseline visits.
* AD involvement >= 10 percent (%) of body surface area (BSA) at screening and baseline visits.
* Peak Pruritus Numerical Rating Scale (PPNRS) score of at least 4.0 at the screening and baseline visit.
* Documented recent history of inadequate response to topical medications (topical corticosteroids [TCS] with or without Topical calcineurin inhibitors [TCI]).
* Female subjects of childbearing potential (that is, fertile, following menarche and until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
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Minimum age
12
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 (<) 30 kilograms (kg).
* Exacerbation of asthma requiring hospitalization in the preceding 12 months. Uncontrolled asthma in the preceding 3 months.
* Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit.
* Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
Note: Subjects with chronic, stable use of prophylactic treatment for recurrent herpes viral infection can be included in this clinical study.
* History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, example, monoclonal antibody) or to any of the study drug excipients.
* Any clinically significant issue, based on investigator judgement.
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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 3
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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
27/06/2019
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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
11/08/2022
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Sample size
Target
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Accrual to date
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Final
941
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Galderma Investigational Site 5441 - Darlinghurst
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Recruitment hospital [2]
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Galderma Investigational Site 5759 - Kogarah
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Recruitment hospital [3]
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Galderma Investigational Site 6152 - Westmead
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Recruitment hospital [4]
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Galderma Investigational Site 5638 - Benowa
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Recruitment hospital [5]
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Galderma Investigational Site 6161 - Brisbane
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Recruitment hospital [6]
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Galderma Investigational Site 6159 - Woodville
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Recruitment hospital [7]
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Galderma Investigational Site 6131 - Carlton
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Recruitment hospital [8]
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Galderma Investigational Site 5366 - East Melbourne
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Recruitment hospital [9]
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Galderma Investigational Site 5458 - Parkville
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Recruitment hospital [10]
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Galderma Investigational Site 5453 - Fremantle
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Recruitment hospital [11]
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Galderma Investigational Site 6153 - Victoria Park
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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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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2145 - Westmead
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Recruitment postcode(s) [4]
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4217 - Benowa
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Recruitment postcode(s) [5]
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4102 - Brisbane
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Recruitment postcode(s) [6]
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5011 - Woodville
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Recruitment postcode(s) [7]
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3053 - Carlton
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Recruitment postcode(s) [8]
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3002 - East Melbourne
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Recruitment postcode(s) [9]
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3050 - Parkville
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Recruitment postcode(s) [10]
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6160 - Fremantle
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Recruitment postcode(s) [11]
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6100 - Victoria Park
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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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Arkansas
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California
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Florida
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Georgia
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Idaho
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Illinois
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Indiana
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Kentucky
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Maine
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Michigan
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Missouri
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Montana
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Nebraska
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Nevada
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New York
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North Carolina
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Texas
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Austria
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Canada
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Ontario
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Canada
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Niagara Falls
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Canada
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Ottawa
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Canada
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Saint John
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Waterloo
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Czechia
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Brno
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Náchod
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Czechia
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Olomouc
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Czechia
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Prague
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Czechia
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Praha
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Germany
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Hesse
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Germany
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Niedersachesen
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Germany
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NRW
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Germany
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Schleswig-Holst
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Germany
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Bad Bentheim
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Germany
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Berlin
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Germany
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Bielefeld
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Germany
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Buxtehude
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Germany
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Darmstadt
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Germany
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Dülmen
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Germany
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Münster
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Germany
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Osnabrück
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Germany
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Stuttgart
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Korea, Republic of
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Bucheon
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Korea, Republic of
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Busan
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Korea, Republic of
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Gyeonggi-do
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Incheon
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Korea, Republic of
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Seoul
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Latvia
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Liepaja
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Latvia
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Riga
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Latvia
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Talsi
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Lithuania
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Netherlands
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Groningen
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Hamilton
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New Zealand
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Wellington
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Poland
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Czestochowa
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Katowice
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Poland
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Lublin
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Poland
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Ostrowiec Swietokrzyski
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Poland
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Poznan
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Poland
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Szczecin
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Poland
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Warszawa
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Wroclaw
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Poland
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Lódz
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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Las Palmas De Gran Canaria
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Spain
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Madrid
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Spain
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Pamplona
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United Kingdom
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Barnsley
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United Kingdom
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Blackpool
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United Kingdom
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Cannock
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United Kingdom
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Glasgow
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Stockton-on-Tees
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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
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Summary
Brief summary
The main purpose of the study was to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.
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Trial website
https://clinicaltrials.gov/study/NCT03985943
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/43/NCT03985943/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/43/NCT03985943/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03985943