Phase 2 study of KHK4577
- Conditions
- Atopic dermatitis
- Registration Number
- JPRN-jRCT2080222314
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 90
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy<br>Percent improvement from baseline in Eczema Area and Severity Index (EASI)
- Secondary Outcome Measures
Name Time Method Efficacy, safety and pharmacokinetics<br>- Investigator's Global Assessment score<br>- Dermatology Life Quality Index<br>- Visual Analog Scale (itching)<br>- The incidence of adverse events<br>- Profile of plasma KHK4577 concentration