Phase 2 Study of KHK4577

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: KHK4577

• Registration Number: NCT02004119
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-09-09
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
KHK4577	KHK4577	-

Primary Outcome Measures

Name	Time	Method
Percent improvement from baseline in Eczema Area and Severity Index (EASI)	Pre-dose, Week 1,2,4 and 6

Secondary Outcome Measures

Name	Time	Method
Dermatology Life Quality Index	Pre-dose, Week 1,2,4 and 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
Incidence of patients with adverse events	From Day 1 through Week 6

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin; 🇯🇵 Sapporo, Hokkaido, Japan