A Phase 3 Clinical Study of KHK4827

Psoriasis Clinical Trial

Official title:

An Extension Study in Subjects With Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782924
• Other study ID #: 4827-003
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2013
• Last updated: February 12, 2015
• Start date: March 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• KHK4827

Locations

Country	Name	City	State
Japan	For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin	Chiyoda-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and types of adverse events and adverse reactions		52 weeks	Yes
Primary	Laboratory values and vital signs		52 weeks	Yes
Primary	Development of anti-KHK4827 antibody		52 weeks	Yes
Secondary	Percent improvement from baseline in Psoriasis Area and Severity Index (PASI)		52 weeks	No
Secondary	A 50% improvement in PASI (PASI 50), PASI 75, PASI 90 and PASI 100 response		52 weeks	No
Secondary	Static physician's global assessment (sPGA) of "clear or almost clear (0 or 1)"		52 weeks	No
Secondary	sPGA of "clear (0)"		52 weeks	No
Secondary	Body surface area involvement (BSA) of lesion		52 weeks	No
Secondary	American College of Rheumatology (ACR) 20 (only in subjects with psoriasis arthritis)		52 weeks	No
Secondary	Profiles of pharmacokinetics	Concentration of KHK4827 in serum	52 weeks	No