Phase 2 Study of KHK4577

Kyowa Kirin

Status and phase

Completed

Phase 2

Conditions

Atopic Dermatitis

Treatments

Drug: Placebo

Drug: KHK4577

Study type

Interventional

Funder types

Industry

Identifiers

NCT02004119

4577-002

Details and patient eligibility

About

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.

Enrollment

93 patients

Sex

All

Ages

20 to 64 years old

Volunteers

No Healthy Volunteers

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.