Phase 2 Study of KHK4577

NCT ID: NCT02004119

Last Updated: 2018-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

KHK4577

Group Type EXPERIMENTAL

KHK4577

Intervention Type DRUG

Interventions

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KHK4577

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Sapporo, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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4577-002

Identifier Type: -

Identifier Source: org_study_id

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