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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/NCT03725722




Registration number
NCT03725722
Ethics application status
Date submitted
30/10/2018
Date registered
31/10/2018
Date last updated
8/07/2021

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.
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 TS) From Baseline to Week 8.
Timepoint [1] 0 0
Week 0 to Week 8
Secondary outcome [2] 0 0
EASI75 at Week 8
Timepoint [2] 0 0
Week 0 to Week 8
Secondary outcome [3] 0 0
Time to vIGA-AD TS
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/05/2020
Sample size
Target
Accrual to date
Final
251
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
New Brunswick
Country [12] 0 0
Canada
State/province [12] 0 0
Ontaria
Country [13] 0 0
Canada
State/province [13] 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/ct2/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
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/NCT03725722