Phase 2 Study of KHK4577

September 9, 2018 updated by: Kyowa Kirin Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0063
        • For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: KHK4577
Drug: KHK4577

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Time Frame: Pre-dose, Week 1,2,4 and 6
Pre-dose, Week 1,2,4 and 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

September 9, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4577-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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