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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
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)
Secondary ID [1] 0 0
RD.03.SPR.114322
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
Timepoint [1] 0 0
From Baseline to Week 24
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
Timepoint [1] 0 0
Week 24
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
Timepoint [2] 0 0
From Week 1 to Week 24
Secondary outcome [3] 0 0
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24
Timepoint [4] 0 0
Baseline, Week 24
Secondary outcome [5] 0 0
Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Timepoint [5] 0 0
Baseline, Week 24
Secondary outcome [6] 0 0
Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24
Timepoint [6] 0 0
Baseline, Week 24
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
Timepoint [7] 0 0
From Week 1 to Week 24
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
Timepoint [8] 0 0
From Week 1 to Week 24
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
Timepoint [9] 0 0
From Week 1 to Week 24
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
Timepoint [10] 0 0
From Week 1 to Week 24
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
Timepoint [11] 0 0
Week 1 to Week 24
Secondary outcome [12] 0 0
Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24
Timepoint [12] 0 0
From Baseline to Week 24
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
Timepoint [13] 0 0
At baseline and Week 24
Secondary outcome [14] 0 0
Number of Participants With Adverse Events
Timepoint [14] 0 0
From screening to Follow-up visit (Week 32)/Early termination visit
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
Timepoint [15] 0 0
Baseline to Week 24
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
Timepoint [16] 0 0
Baseline to Week 24
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
Timepoint [17] 0 0
Baseline to Week 24

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/09/2018
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Galderma Investigational Site - Benowa
Recruitment hospital [2] 0 0
Galderma Investigational Site - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigational Site - Melbourne
Recruitment hospital [4] 0 0
Galderma Investigational Site - Phillip
Recruitment postcode(s) [1] 0 0
4217 QLD - Benowa
Recruitment postcode(s) [2] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [3] 0 0
VIC3002 - Melbourne
Recruitment postcode(s) [4] 0 0
ACT2606 - Phillip
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Rhode Island
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Virginia
Country [15] 0 0
Canada
State/province [15] 0 0
Calgary
Country [16] 0 0
Canada
State/province [16] 0 0
Markham
Country [17] 0 0
Canada
State/province [17] 0 0
Oakville
Country [18] 0 0
Canada
State/province [18] 0 0
Ottawa
Country [19] 0 0
Canada
State/province [19] 0 0
Peterborough
Country [20] 0 0
Canada
State/province [20] 0 0
Richmond Hill
Country [21] 0 0
Canada
State/province [21] 0 0
Sainte-Foy
Country [22] 0 0
Canada
State/province [22] 0 0
Waterloo
Country [23] 0 0
France
State/province [23] 0 0
Bordeaux
Country [24] 0 0
France
State/province [24] 0 0
Lille
Country [25] 0 0
France
State/province [25] 0 0
Marseille
Country [26] 0 0
France
State/province [26] 0 0
Nice
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Toulouse
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Darmstadt
Country [31] 0 0
Germany
State/province [31] 0 0
Erlangen
Country [32] 0 0
Germany
State/province [32] 0 0
Frankfurt
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Hannöver
Country [35] 0 0
Germany
State/province [35] 0 0
Heidelberg
Country [36] 0 0
Germany
State/province [36] 0 0
Langenau
Country [37] 0 0
Germany
State/province [37] 0 0
Mainz
Country [38] 0 0
Germany
State/province [38] 0 0
München
Country [39] 0 0
Germany
State/province [39] 0 0
Osnabrück
Country [40] 0 0
Germany
State/province [40] 0 0
Stuttgart
Country [41] 0 0
Poland
State/province [41] 0 0
Katowice
Country [42] 0 0
Poland
State/province [42] 0 0
Kraków
Country [43] 0 0
Poland
State/province [43] 0 0
Lublin
Country [44] 0 0
Poland
State/province [44] 0 0
Warsaw
Country [45] 0 0
Poland
State/province [45] 0 0
Wroclaw
Country [46] 0 0
Poland
State/province [46] 0 0
Lódz

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Galderma R&D
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03100344
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03100344