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Phase 2 Study of KHK4577

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
KHK4577
Placebo
Sponsored by
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

KHK4577

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Investigator's Global Assessment score
Dermatology Life Quality Index
Visual Analog Scale (itching)
Incidence of patients with adverse events
Profile of pharmacokinetics of plasma KHK4577 concentration

Full Information

First Posted
December 3, 2013
Last Updated
September 9, 2018
Sponsor
Kyowa Kirin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02004119
Brief Title
Phase 2 Study of KHK4577
Official Title
Randomized Double-blind Placebo-controlled Study of KHK4577 in Patients With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
KHK4577
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK4577
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent improvement from baseline in Eczema Area and Severity Index (EASI)
Time Frame
Pre-dose, Week 1,2,4 and 6
Secondary Outcome Measure Information:
Title
Change from baseline in Investigator's Global Assessment score
Time Frame
Pre-dose, Week 1,2,4 and 6
Title
Dermatology Life Quality Index
Time Frame
Pre-dose, Week 1,2,4 and 6
Title
Visual Analog Scale (itching)
Time Frame
Pre-dose, Week 1,2,4 and 6
Title
Incidence of patients with adverse events
Time Frame
From Day 1 through Week 6
Title
Profile of pharmacokinetics of plasma KHK4577 concentration
Time Frame
pre-dose, Week 1,2,4 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase 2 Study of KHK4577

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