Atopic dermatitis
Conditions
Interventions
investigational material(s)
Generic name etc : KHK4577
INN of investigational material :
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational materi
Sponsors
Kyowa Hakko Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| Efficacy Percent improvement from baseline in Eczema Area and Severity Index (EASI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy, safety and pharmacokinetics - Investigator's Global Assessment score - Dermatology Life Quality Index - Visual Analog Scale (itching) - The incidence of adverse events - Profile of plasma KHK4577 concentration | — |
Outcome results
None listed