Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
Query!
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)
Query!
Secondary ID [1]
0
0
RD.03.SPR.114322
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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)
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
From Baseline to Week 24
Query!
Secondary outcome [1]
0
0
Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS =1 [None - Mild]) at Week 24
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 24
Query!
Secondary outcome [2]
0
0
Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) =4 at Each Timepoint up to Week 24
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From Week 1 to Week 24
Query!
Secondary outcome [3]
0
0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Baseline, Week 24
Query!
Secondary outcome [4]
0
0
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Baseline, Week 24
Query!
Secondary outcome [5]
0
0
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Baseline, Week 24
Query!
Secondary outcome [6]
0
0
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Baseline, Week 24
Query!
Secondary outcome [7]
0
0
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
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
From Week 1 to Week 24
Query!
Secondary outcome [8]
0
0
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
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
From Week 1 to Week 24
Query!
Secondary outcome [9]
0
0
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
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
From Week 1 to Week 24
Query!
Secondary outcome [10]
0
0
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
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
From Week 1 to Week 24
Query!
Secondary outcome [11]
0
0
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
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Week 1 to Week 24
Query!
Secondary outcome [12]
0
0
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
From Baseline to Week 24
Query!
Secondary outcome [13]
0
0
Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
At baseline and Week 24
Query!
Secondary outcome [14]
0
0
Number of Participants With Adverse Events
Query!
Assessment method [14]
0
0
To evaluate the safety of nemolizumab in participants with moderate-to-severe AD
Query!
Timepoint [14]
0
0
From screening to Follow-up visit (Week 32)/Early termination visit
Query!
Secondary outcome [15]
0
0
Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Query!
Assessment method [15]
0
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 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.
Query!
Timepoint [15]
0
0
Baseline to Week 24
Query!
Secondary outcome [16]
0
0
Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Query!
Assessment method [16]
0
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.
Query!
Timepoint [16]
0
0
Baseline to Week 24
Query!
Secondary outcome [17]
0
0
Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24
Query!
Assessment method [17]
0
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.
Query!
Timepoint [17]
0
0
Baseline to Week 24
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
14/06/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
21/09/2018
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
226
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Galderma Investigational Site - Benowa
Query!
Recruitment hospital [2]
0
0
Galderma Investigational Site - Kogarah
Query!
Recruitment hospital [3]
0
0
Galderma Investigational Site - Melbourne
Query!
Recruitment hospital [4]
0
0
Galderma Investigational Site - Phillip
Query!
Recruitment postcode(s) [1]
0
0
4217 QLD - Benowa
Query!
Recruitment postcode(s) [2]
0
0
NSW 2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
VIC3002 - Melbourne
Query!
Recruitment postcode(s) [4]
0
0
ACT2606 - Phillip
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Louisiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New York
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
North Carolina
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Rhode Island
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Virginia
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Calgary
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Markham
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Oakville
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Ottawa
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Peterborough
Query!
Country [20]
0
0
Canada
Query!
State/province [20]
0
0
Richmond Hill
Query!
Country [21]
0
0
Canada
Query!
State/province [21]
0
0
Sainte-Foy
Query!
Country [22]
0
0
Canada
Query!
State/province [22]
0
0
Waterloo
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Bordeaux
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Lille
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Marseille
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Nice
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Paris
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Toulouse
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Berlin
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Darmstadt
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Erlangen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Frankfurt
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Hamburg
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Hannöver
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Heidelberg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Langenau
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Mainz
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
München
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Osnabrück
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Stuttgart
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Katowice
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Kraków
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Lublin
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Warsaw
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Wroclaw
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Lódz
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Galderma R&D
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03100344
Query!
Trial related presentations / publications
Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/44/NCT03100344/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/44/NCT03100344/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03100344
Download to PDF