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NCT02004119 Clinical Trial

Phase 2 Study of KHK4577

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02004119
Other study ID # 4577-002
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 2013
Est. completion date December 2014

Study information
Verified date August 2018
Source Kyowa Hakko Kirin Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 20 Years to 64 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• KHK4577

• Placebo

Locations
Country Name City State
Japan For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin Sapporo Hokkaido

Sponsors (1)
Lead Sponsor Collaborator
Kyowa Hakko Kirin Co., Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent improvement from baseline in Eczema Area and Severity Index (EASI) Pre-dose, Week 1,2,4 and 6
Secondary Change from baseline in Investigator's Global Assessment score Pre-dose, Week 1,2,4 and 6
Secondary Dermatology Life Quality Index Pre-dose, Week 1,2,4 and 6
Secondary Visual Analog Scale (itching) Pre-dose, Week 1,2,4 and 6
Secondary Incidence of patients with adverse events From Day 1 through Week 6
Secondary Profile of pharmacokinetics of plasma KHK4577 concentration pre-dose, Week 1,2,4 and 6
See also
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