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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03985943




Registration number
NCT03985943
Ethics application status
Date submitted
11/06/2019
Date registered
14/06/2019
Date last updated
30/11/2020

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

1. Male or female subjects aged = 12 years at the screening visit

Note: Enrollment of subjects aged 12 to 17 years will begin after an IDMC has assessed
interim safety data from the phase 2 study (Protocol 116912) and provided
recommendations to the sponsor, who will then determine the eligibility of this age
group for enrollment in the study.

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

3. EASI score = 16

4. IGA score = 3

5. AD involvement = 10% of BSA

6. Documented recent history of inadequate response to topical medications (TCS with or
without TCI).

7. Female subjects of childbearing potential must agree either to be strictly abstinent
throughout the study and for 12 weeks after the last study drug injection, or to use
an effective and approved method of contraception throughout the study and for 12
weeks after the last study drug injection, or to use an effective 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
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Body weight < 30 kg.

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

3. Cutaneous infection within 1 week or any infection requiring treatment with oral or
parenteral antibiotics, antivirals, antiparasitics, or antifungals within 1 week

4. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product
(plasma-derived or recombinant, eg, monoclonal antibody)

5. Any clinically significant issue, based 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,nVIC,WA
Recruitment hospital [1] 0 0
Galderma Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
Galderma Investigational Site - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigational Site - Westmead
Recruitment hospital [4] 0 0
Galderma Investigational Site - Benowa
Recruitment hospital [5] 0 0
Not yet recruiting - Woodville
Recruitment hospital [6] 0 0
Galderma Investigational Site - Carlton
Recruitment hospital [7] 0 0
Galderma Investigational Site - East Melbourne
Recruitment hospital [8] 0 0
Galderma Investigational Site - Parkville
Recruitment hospital [9] 0 0
Galderma Investigational Site - Fremantle
Recruitment hospital [10] 0 0
Galderma Investigational Site - Victoria Park
Recruitment hospital [11] 0 0
Galderma Investigation Site - Brisbane
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
5011 - Woodville
Recruitment postcode(s) [6] 0 0
3053 - Carlton
Recruitment postcode(s) [7] 0 0
3002 - East Melbourne
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3052 - Parkville
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment postcode(s) [11] 0 0
6100 - Victoria Park
Recruitment postcode(s) [12] 0 0
4102 - Brisbane
Recruitment outside Australia
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Nebraska
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Nevada
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North Carolina
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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
Safety and efficacy of nemolizumab in subjects with moderate-to-severe atopic dermatitis
Trial website
https://clinicaltrials.gov/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
Galderma Research & Development
Address 0 0
Country 0 0
Phone 0 0
817-961-5000
Fax 0 0
Email 0 0
clinical.studies@galderma.com
Contact person for scientific queries

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