Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis

Kyowa Kirin Co., Ltd.1 site in 1 country93 target enrollmentNovember 2013

ConditionsAtopic Dermatitis

InterventionsPlacebo KHK4577

DrugsKHK4577 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Atopic Dermatitis
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 93
Locations: 1
Primary Endpoint: Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

Eligibility 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.

Arms & Interventions

Placebo

Intervention: Placebo

KHK4577

Intervention: KHK4577

Outcomes

Primary Outcomes

Percent improvement from baseline in Eczema Area and Severity Index (EASI)

Time Frame: Pre-dose, Week 1,2,4 and 6

Secondary Outcomes

Dermatology Life Quality Index(Pre-dose, Week 1,2,4 and 6)
Incidence of patients with adverse events(From Day 1 through Week 6)
Change from baseline in Investigator's Global Assessment score(Pre-dose, Week 1,2,4 and 6)
Visual Analog Scale (itching)(Pre-dose, Week 1,2,4 and 6)
Profile of pharmacokinetics of plasma KHK4577 concentration(pre-dose, Week 1,2,4 and 6)