Phase 2 Study of KHK4577

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.

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:

• 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.