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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
30/06/2020

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