Atopic Dermatitis
Conditions
Brief summary
This study is an randomized double-blind placebo-controlled study to evaluate the efficacy and the safety of oral KHK4577 for 6 weeks in patients with atopic dermatitis. Pharmacokinetics of KHK4577 will also be assessed.
Interventions
DRUGKHK4577
DRUGPlacebo
Sponsors
Kyowa Kirin Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Subject has signed voluntarily the written informed consent form to participate in this study. * Subject has been diagnosed as atopic dermatitis according to Guidelines for Management of Atopic Dermatitis (2009). * Rajka & Langeland criteria of \>/= 4.5 at screening visit * Investigator's Global Assessment (IGA) score of \>/= 3 at screening visit
Exclusion criteria
* Evidence of skin disorders/conditions that would interfere with the assessment of the effect of the study drug. * Subject received photochemotherapy or systemic immunosuppressants within 2 weeks prior to informed consent. * Subject has any active infectious disease(except localized infection) which needs to treat with systemic antibiotics(eg. antibacterial, antifungal or antiviral drugs) within 4 weeks prior to informed consent. * Subject has complications / history of drug abuse or alcoholism. * Subject has drug allergy or history of allergic reaction to a drug medicine. * Subject has a significant concurrent medical conditions as defined in the study protocol. * Subject is breast-feeding, pregnant or planning to become pregnant in this study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent improvement from baseline in Eczema Area and Severity Index (EASI) | Pre-dose, Week 1,2,4 and 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Investigator's Global Assessment score | Pre-dose, Week 1,2,4 and 6 |
| Dermatology Life Quality Index | Pre-dose, Week 1,2,4 and 6 |
| Visual Analog Scale (itching) | Pre-dose, Week 1,2,4 and 6 |
| Incidence of patients with adverse events | From Day 1 through Week 6 |
| Profile of pharmacokinetics of plasma KHK4577 concentration | pre-dose, Week 1,2,4 and 6 |
Countries
Japan
Outcome results
None listed