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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03725722




Registration number
NCT03725722
Ethics application status
Date submitted
30/10/2018
Date registered
31/10/2018
Date last updated
8/02/2019

Titles & IDs
Public title
Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over an 8-week Treatment Period in Adult Subjects With Atopic Dermatitis.
Scientific title
A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose Ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Applications of Delgocitinib Cream 1, 3, 8, 20 mg/g for 8 Weeks in Adult Subjects With Mild to Severe Atopic Dermatitis.
Secondary ID [1] 0 0
LP0133-1275
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 - Delgocitinib cream
Treatment: Drugs - Delgocitinib cream vehicle

Experimental: Delgocitinib cream 1 mg/g - Delgocitinib cream applied twice daily for 8 weeks

Experimental: Delgocitinib cream 3 mg/g - Delgocitinib cream applied twice daily for 8 weeks

Experimental: Delgocitinib cream 8 mg/g - Delgocitinib cream applied twice daily for 8 weeks

Experimental: Delgocitinib cream 20 mg/g - Delgocitinib cream applied twice daily for 8 weeks

Placebo Comparator: Delgocitinib cream vehicle - Delgocitinib cream vehicle applied twice daily for 8 weeks


Treatment: Drugs: Delgocitinib cream
Cream for topical application

Treatment: Drugs: Delgocitinib cream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

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

Outcomes
Primary outcome [1] 0 0
Change from baseline (Week 0) to Week 8 in Eczema Area and Severity Index (EASI) score. - EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72, with higher values indicating more severe or more extensive condition.
Timepoint [1] 0 0
Week 0 to Week 8
Secondary outcome [1] 0 0
Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with =2-step improvement (vIGA-AD 0/1) from baseline to Week 8. - vIGA-AD is an instrument used in clinical trials to assess the subject's global disease severity and is based on a 5-point scale ranging from 0 (clear) to 4 (severe)
Timepoint [1] 0 0
Week 0 to Week 8
Secondary outcome [2] 0 0
EASI75 at Week 8 - EASI75 is defined as at least 75% reduction in EASI from baseline.
Timepoint [2] 0 0
Week 0 to Week 8
Secondary outcome [3] 0 0
Time to vIGA-AD 0/1 - The time to vIGA-AD 0/1 response is defined as the time from baseline to first assessment of a vIGA-AD 0/1
Timepoint [3] 0 0
Week 0 to Week 8

Eligibility
Key inclusion criteria
Key

- Age 18 years and above.

- Diagnosis of AD as defined by the Hanifin and Rajka 1980 criteria for AD.

- History of AD for =1 year.

- AD involvement of 5-50% treatable body surface area at screening and at baseline
(excluding scalp).

- Disease severity graded as mild to severe according to vIGA-AD (i.e. vIGA-AD =2) at
screening and baseline.

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- AD lesion(s) on scalp at screening and/or baseline.

- Active dermatologic conditions that may confound the diagnosis of AD or would
interfere with assessment of treatment, such as scabies, cutaneous lymphoma, rosacea,
urticaria, or psoriasis.

- Known active allergic or irritant contact dermatitis that is likely to interfere with
the assessment of severity of AD.

- Use of tanning beds or phototherapy within 4 weeks prior to baseline.

- Systemic treatment with immunosuppressive/modulating drugs or corticosteroids within 4
weeks prior to baseline or 3 or more bleach baths any week within 4 weeks prior to
baseline.

- Treatment with topical corticosteroids, topical calcineurin inhibitors, topical
phosphodiesterase-4 inhibitors, or oral antibiotics within 2 weeks prior to baseline.

- Change in systemic antihistamine therapy within 2 weeks prior to baseline i.e. the
subjects must not start antihistamine treatment or change the current dosage regime
within 2 weeks prior to baseline.

- Receipt of live attenuated vaccines within 4 weeks prior to baseline.

- Treatment with any marketed or investigational biologic agents within 6 months or 5
half-lives prior to baseline, or until cell counts return to normal, whichever is
longer.

- History of any active skin infection within 1 week prior to baseline.

- Clinically significant infection (systemic infection or serious skin infection
requiring parenteral treatment) within 4 weeks prior to baseline.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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)
Recruitment hospital [1] 0 0
Leo Pharma Investigational Site - Carlton
Recruitment hospital [2] 0 0
Leo Pharma Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
Leo Pharma Investigational Site - East Melbourne
Recruitment hospital [4] 0 0
Leo Pharma Investigational Site - Hectorville
Recruitment hospital [5] 0 0
Leo Pharma Investigational Site 1 - Kogarah
Recruitment hospital [6] 0 0
Leo Pharma Investigational Site - Kogarah
Recruitment hospital [7] 0 0
Leo Pharma Investigational Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
3002 - East Melbourne
Recruitment postcode(s) [4] 0 0
5073 - Hectorville
Recruitment postcode(s) [5] 0 0
2217 - Kogarah
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
New Brunswick
Country [14] 0 0
Canada
State/province [14] 0 0
Ontaria
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LEO Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a double-blind, multi-centre, randomised, 5-arm, vehicle-controlled, parallel-group
trial. The trial is designed to establish a dose-response signal and investigate the efficacy
and safety of delgocitinib cream in the treatment of adult subjects with mild to severe
atopic dermatitis (AD).
Trial website
https://clinicaltrials.gov/show/NCT03725722
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Expert
Address 0 0
LEO Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
LEO Pharma A/S
Address 0 0
Country 0 0
Phone 0 0
(+1) 877-557-1168
Fax 0 0
Email 0 0
disclosure@leo-pharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03725722