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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
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
Secondary ID [1] 0 0
RD.06.SPR.118161
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate-to-Severe 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 - Placebo
Treatment: Drugs - Nemolizumab

Placebo comparator: Placebo - Placebo

Experimental: Nemolizumab - Nemolizumab Active


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: Nemolizumab
Nemolizumab
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Percentage of Participants With an Investigator's Global Assessment (IGA) Success (IGA of 0 or 1 and a >= 2-point Reduction): Severe Pruritus Population
Timepoint [2] 0 0
Week 16
Primary outcome [3] 0 0
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at Week 16: ITT Population
Timepoint [3] 0 0
Week 16
Primary outcome [4] 0 0
Percentage of Participants With >=75% Improvement in Eczema Area and Severity Index (EASI-75) at 16: Severe Pruritus Population
Timepoint [4] 0 0
Week 16
Secondary outcome [1] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: ITT Population
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 16: Severe Pruritus Population
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: ITT Population
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Percentage of Participants With <2 Points in Weekly Average PP NRS at Week 16: Severe Pruritus Population
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: ITT Population
Timepoint [5] 0 0
Week 16
Secondary outcome [6] 0 0
Percentage of Participants With an Improvement of Sleep Disturbance Numeric Rating Scale (SD NRS) >=4 at Week 16: Severe Pruritus Population
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: ITT Population
Timepoint [7] 0 0
Week 4
Secondary outcome [8] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 4: Severe Pruritus Population
Timepoint [8] 0 0
Week 4
Secondary outcome [9] 0 0
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: ITT Population
Timepoint [9] 0 0
Week 4
Secondary outcome [10] 0 0
Percentage of Participants With Peak Pruritus Numeric Rating Scale (PP NRS) <2 at Week 4: Severe Pruritus Population
Timepoint [10] 0 0
Week 4
Secondary outcome [11] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: ITT Population
Timepoint [11] 0 0
Week 2
Secondary outcome [12] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 2: Severe Pruritus Population
Timepoint [12] 0 0
Week 2
Secondary outcome [13] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: ITT Population
Timepoint [13] 0 0
Week 1
Secondary outcome [14] 0 0
Percentage of Participants With Improvement of >=4 Points in Weekly Average Peak Pruritus Numeric Rating Scale (PP NRS) at Week 1: Severe Pruritus Population
Timepoint [14] 0 0
Week 1

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.

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

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 3
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
27/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/08/2022
Sample size
Target
Accrual to date
Final
941
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Galderma Investigational Site 5441 - Darlinghurst
Recruitment hospital [2] 0 0
Galderma Investigational Site 5759 - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigational Site 6152 - Westmead
Recruitment hospital [4] 0 0
Galderma Investigational Site 5638 - Benowa
Recruitment hospital [5] 0 0
Galderma Investigational Site 6161 - Brisbane
Recruitment hospital [6] 0 0
Galderma Investigational Site 6159 - Woodville
Recruitment hospital [7] 0 0
Galderma Investigational Site 6131 - Carlton
Recruitment hospital [8] 0 0
Galderma Investigational Site 5366 - East Melbourne
Recruitment hospital [9] 0 0
Galderma Investigational Site 5458 - Parkville
Recruitment hospital [10] 0 0
Galderma Investigational Site 5453 - Fremantle
Recruitment hospital [11] 0 0
Galderma Investigational Site 6153 - Victoria Park
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
4102 - Brisbane
Recruitment postcode(s) [6] 0 0
5011 - Woodville
Recruitment postcode(s) [7] 0 0
3053 - Carlton
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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California
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Florida
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Idaho
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Illinois
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Vienna
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Ontario
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Niagara Falls
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Ottawa
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Saint John
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Alicante
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Barcelona
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Madrid
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Pamplona
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United Kingdom
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Barnsley
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Blackpool
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Cannock
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Glasgow
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Liverpool
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London
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Manchester
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United Kingdom
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Stockton-on-Tees

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03985943