Back to resultsA Phase 3 Clinical Study of KHK4827
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK4827
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Subject has voluntarily signed the written informed consent form to participate in this study
- Subject has completed the week 12 evaluation of Study 4827-002
Exclusion Criteria:
- Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
- Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
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
Experimental
Experimental
Arm Label
KHK4827 140mg SC
KHK4827 210mg SC
Arm Description
Outcomes
Primary Outcome Measures
Incidence and types of adverse events and adverse reactions
Laboratory values and vital signs
Development of anti-KHK4827 antibody
Secondary Outcome Measures
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"
sPGA of "clear (0)"
Body surface area involvement (BSA) of lesion
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
Profiles of pharmacokinetics
Concentration of KHK4827 in serum
Full Information
NCT ID
NCT01782924
First Posted
January 27, 2013
Last Updated
February 12, 2015
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01782924
Brief Title
A Phase 3 Clinical Study of KHK4827
Official Title
An Extension Study in Subjects With Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (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 designed to evaluate safety and efficacy of long-term exposure of KHK4827 in subjects with moderate to severe plaque psoriasis who have completed the preceding Study 4827-002.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KHK4827 140mg SC
Arm Type
Experimental
Arm Title
KHK4827 210mg SC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
KHK4827
Primary Outcome Measure Information:
Title
Incidence and types of adverse events and adverse reactions
Time Frame
52 weeks
Title
Laboratory values and vital signs
Time Frame
52 weeks
Title
Development of anti-KHK4827 antibody
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)
Time Frame
52 weeks
Title
A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response
Time Frame
52 weeks
Title
Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"
Time Frame
52 weeks
Title
sPGA of "clear (0)"
Time Frame
52 weeks
Title
Body surface area involvement (BSA) of lesion
Time Frame
52 weeks
Title
American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)
Time Frame
52 weeks
Title
Profiles of pharmacokinetics
Description
Concentration of KHK4827 in serum
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has voluntarily signed the written informed consent form to participate in this study
Subject has completed the week 12 evaluation of Study 4827-002
Exclusion Criteria:
Subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration)
Subject has been judged to be ineligible for participation in the study by the investigators/subinvestigators
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
100-8185
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Clinical Study of KHK4827
We'll reach out to this number within 24 hrs