A Phase 3 Clinical Study of KHK 4827

An Extension Study of KHK4827 in Subjects With Plaque Psoriasis (Psoriasis Vulgaris, Psoriatic Arthritis), Pustular Psoriasis (Generalized) and Psoriatic Erythroderma

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris; Psoriatic Arthritis; Pustular; Psoriasis, Palmaris Et Plantaris; Psoriatic Erythroderma
• Intervention / Treatment: Drug: KHK4827 140mg SC; Drug: KHK4827 210mg SC

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chiyoda-ku, Tokyo, Japan, 100-8185
      • For additional information regarding investigative sites for this trial, contact Kyowa Kirin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KHK4827 140mg SC	Drug: KHK4827 140mg SC; Experimental1:KHK4827 140mg subcutaneous injection
Experimental: KHK4827 210mg SC	Drug: KHK4827 210mg SC; Experimental2:KHK4827 210mg subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and types of adverse events and adverse reactions	28 weeks
Anti-KHK4827 antibody	28 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in psoriasis area and severity index (PASI) compared to the data obtained before the first dose of investigational product in this study.	28 weeks
Percent improvement in PASI	28 Weeks
PASI 50, 75, 90, and 100	28 Weeks
Static physician's global assessment (sPGA) of "0 (clear) or 1(almost clear)"	28 Weeks
sPGA of "0 (clear)	28 weeks
Change in body surface area involvement (BSA) of lesion	28 weeks
Clinical Global Impression (CGI)	28 weeks
American College of Rheumatology (ACR) 20	28 weeks
Pustular symptom score	28 weeks
Serum KHK4827 concentration	28 weeks

Collaborators and Investigators

• Sponsor: Kyowa Kirin Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): January 28, 2015
• Study Completion (Actual): July 4, 2016

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimated): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Joint Diseases; Musculoskeletal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Dermatitis; Skin Diseases, Eczematous; Spondylarthropathies; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Arthritis, Psoriatic; Dermatitis, Exfoliative; Dermatologic Agents; Brodalumab
• Other Study ID Numbers: 4827-005