Back to resultsA Phase 3 Clinical Study of KHK 4827
Primary Purpose
Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KHK4827 140mg SC
KHK4827 210mg SC
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Subject has voluntarily signed the written informed consent form to participate in this study
- Subject has completed the week 52 evaluation either in Study 003 or 004
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/sub investigators
Sites / Locations
- For additional information regarding investigative sites for this trial, contact Kyowa 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
Anti-KHK4827 antibody
Secondary Outcome Measures
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
Percent improvement in PASI
PASI 50, 75, 90, and 100
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
sPGA of "0 (clear)
Change in body surface area involvement (BSA) of lesion
Clinical Global Impression (CGI)
American College of Rheumatology (ACR) 20
Pustular symptom score
Serum KHK4827 concentration
Full Information
NCT ID
NCT02052609
First Posted
January 30, 2014
Last Updated
August 24, 2023
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02052609
Brief Title
A Phase 3 Clinical Study of KHK 4827
Official Title
An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 28, 2015 (Actual)
Study Completion Date
July 4, 2016 (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 the safety and efficacy of long-term exposure to KHK4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed Study 4827-003 (Study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the Study 4827-004 (Study 004).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris, Psoriatic Arthritis, Pustular; Psoriasis, Palmaris Et Plantaris, Psoriatic Erythroderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
155 (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 140mg SC
Intervention Description
Experimental1:KHK4827 140mg subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
KHK4827 210mg SC
Intervention Description
Experimental2:KHK4827 210mg subcutaneous injection
Primary Outcome Measure Information:
Title
Incidence and types of adverse events and adverse reactions
Time Frame
28 weeks
Title
Anti-KHK4827 antibody
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.
Time Frame
28 weeks
Title
Percent improvement in PASI
Time Frame
28 Weeks
Title
PASI 50, 75, 90, and 100
Time Frame
28 Weeks
Title
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"
Time Frame
28 Weeks
Title
sPGA of "0 (clear)
Time Frame
28 weeks
Title
Change in body surface area involvement (BSA) of lesion
Time Frame
28 weeks
Title
Clinical Global Impression (CGI)
Time Frame
28 weeks
Title
American College of Rheumatology (ACR) 20
Time Frame
28 weeks
Title
Pustular symptom score
Time Frame
28 weeks
Title
Serum KHK4827 concentration
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 52 evaluation either in Study 003 or 004
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/sub investigators
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact Kyowa 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 KHK 4827
We'll reach out to this number within 24 hrs