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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/NCT03985943




Registration number
NCT03985943
Ethics application status
Date submitted
11/06/2019
Date registered
14/06/2019
Date last updated
21/09/2023

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
Proportion of subjects with an IGA success (IGA of 0 or 1) and a = 2-point reduction
Timepoint [1] 0 0
Baseline to Week 16
Primary outcome [2] 0 0
Proportion of subjects with EASI-75
Timepoint [2] 0 0
Baseline to Week 16
Secondary outcome [1] 0 0
Proportion of subjects with an improvement of PP NRS = 4
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Proportion of subjects with PP NRS < 2
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Proportion of subjects with an improvement of sleep disturbance NRS (SD NRS) = 4
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
Proportion of subjects with an improvement of PP NRS = 4
Timepoint [4] 0 0
Week 4
Secondary outcome [5] 0 0
Proportion of subjects with PP NRS < 2
Timepoint [5] 0 0
Week 4
Secondary outcome [6] 0 0
Proportion of subjects with an improvement of PP NRS = 4
Timepoint [6] 0 0
Week 2
Secondary outcome [7] 0 0
Proportion of subjects with an improvement of PP NRS = 4
Timepoint [7] 0 0
Week 1
Secondary outcome [8] 0 0
Proportion of subjects with EASI-75 and improvement of PP NRS = 4
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
Proportion of subjects with IGA success and improvement of PP NRS = 4
Timepoint [9] 0 0
Week 16

Eligibility
Key inclusion criteria
Key

- Male or female subjects aged = 12 years at the screening visit Note: Enrollment of
subjects aged 12 to 17 years has been opened after the IDMC has assessed interim
safety data from the phase 2 study (Protocol 116912) and provided recommendations to
the sponsor, who then determined the eligibility of this age group for enrollment in
the study

- Chronic AD that has been documented for at least 2 years

- EASI score = 16

- IGA score = 3

- AD involvement = 10% of BSA

- PPNRS score of at least 4.0 at the screening and baseline visit

- Documented recent history of inadequate response to topical medications (TCS with or
without 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 kg

- Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical
study

- 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 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, eg, 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
30/06/2019
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 6160 - Parkville
Recruitment hospital [11] 0 0
Galderma Investigational Site 5453 - Fremantle
Recruitment hospital [12] 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
3052 - Parkville
Recruitment postcode(s) [11] 0 0
6160 - Fremantle
Recruitment postcode(s) [12] 0 0
6100 - Victoria Park
Recruitment outside Australia
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Newcastle
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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
The main purpose of the study is 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03985943
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03985943